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Suvi T Vaara - One of the best experts on this subject based on the ideXlab platform.

  • protocol and statistical analysis plan for the restricted Fluid Therapy versus standard treatment in acute kidney injury reverse aki randomized controlled pilot trial
    Acta Anaesthesiologica Scandinavica, 2020
    Co-Authors: Eric Hoste, Suvi T Vaara, Marlies Ostermann, Tuomas Selander, Laurent Bitker, Antoine G Schneider, Elettra Poli, Michael Joannidis
    Abstract:

    Background Fluid accumulation frequently coexists with acute kidney injury (AKI) and is associated with increased risk for AKI progression and mortality. Among septic shock patients, restricted use of resuscitation Fluid has been reported to reduce the risk of worsening of AKI. Restrictive Fluid Therapy, however, has not been studied in the setting of established AKI. Here, we present the protocol and statistical analysis plan of the REstricted Fluid Therapy VERsus Standard trEatment in Acute Kidney Injury-the REVERSE-AKI trial that compares a restrictive Fluid Therapy regimen to standard Therapy in critically ill patients with AKI. Methods REVERSE-AKI is an investigator-initiated, multinational, open-label, randomized, controlled, feasibility pilot trial conducted in seven ICUs in five countries. We aim to randomize 100 critically ill patients with AKI to a restrictive Fluid treatment regimen vs standard management. In the restrictive Fluid Therapy regimen, the daily Fluid balance target is neutral or negative. The primary outcome is the cumulative Fluid balance assessed after 72 hours from randomization. Secondary outcomes include safety, feasibility, duration, and severity of AKI, and outcome at 90 days (mortality and dialysis dependence). Conclusions This is the first multinational trial investigating the feasibility and safety of a restrictive Fluid Therapy regimen in critically ill patients with AKI. Trial registration clinical.trials.gov NCT03251131.

Maxime Cannesson - One of the best experts on this subject based on the ideXlab platform.

  • hydroxyethyl starch for perioperative goal directed Fluid Therapy in 2020 a narrative review
    BMC Anesthesiology, 2020
    Co-Authors: Bernd Saugel, Maxime Cannesson, Alexandre Joosten, Amelie Delaporte, Sean Coeckelenbergh, Brenton Alexander, J Duranteau, Jean Louis Vincent
    Abstract:

    Background Perioperative Fluid management - including the type, dose, and timing of administration -directly affects patient outcome after major surgery. The objective of Fluid administration is to optimize intravascular Fluid status to maintain adequate tissue perfusion. There is continuing controversy around the perioperative use of crystalloid versus colloid Fluids. Unfortunately, the importance of Fluid volume, which significantly influences the benefit-to-risk ratio of each chosen solution, has often been overlooked in this debate. Main text The volume of Fluid administered during the perioperative period can influence the incidence and severity of postoperative complications. Regrettably, there is still huge variability in Fluid administration practices, both intra-and inter-individual, among clinicians. Goal-directed Fluid Therapy (GDFT), aimed at optimizing flow-related variables, has been demonstrated to have some clinical benefit and has been recommended by multiple professional societies. However, this approach has failed to achieve widespread adoption. A closed-loop Fluid administration system designed to assist anesthesia providers in consistently applying GDFT strategies has recently been developed and tested. Such an approach may change the crystalloid versus colloid debate. Because colloid solutions have a more profound effect on intravascular volume and longer plasma persistence, their use in this more "controlled" context could be associated with a lower Fluid balance, and potentially improved patient outcome. Additionally, most studies that have assessed the impact of a GDFT strategy on the outcome of high-risk surgical patients have used hydroxyethyl starch (HES) solutions in their protocols. Some of these studies have demonstrated beneficial effects, while none of them has reported severe complications. Conclusions The type and volume of Fluid used for perioperative management need to be individualized according to the patient's hemodynamic status and clinical condition. The amount of Fluid given should be guided by well-defined physiologic targets. Compliance with a predefined hemodynamic protocol may be optimized by using a computerized system. The type of Fluid should also be individualized, as should any drug Therapy, with careful consideration of timing and dose. It is our perspective that HES solutions remain a valid option for Fluid Therapy in the perioperative context because of their effects on blood volume and their reasonable benefit/risk profile.

  • hydroxyethyl starch for perioperative goal directed Fluid Therapy in 2020 a narrative review
    BMC Anesthesiology, 2020
    Co-Authors: Bernd Saugel, Maxime Cannesson, Alexandre Joosten, Amelie Delaporte, Sean Coeckelenbergh, Brenton Alexander, J Duranteau, Jean Louis Vincent
    Abstract:

    Perioperative Fluid management – including the type, dose, and timing of administration –directly affects patient outcome after major surgery. The objective of Fluid administration is to optimize intravascular Fluid status to maintain adequate tissue perfusion. There is continuing controversy around the perioperative use of crystalloid versus colloid Fluids. Unfortunately, the importance of Fluid volume, which significantly influences the benefit-to-risk ratio of each chosen solution, has often been overlooked in this debate. The volume of Fluid administered during the perioperative period can influence the incidence and severity of postoperative complications. Regrettably, there is still huge variability in Fluid administration practices, both intra-and inter-individual, among clinicians. Goal-directed Fluid Therapy (GDFT), aimed at optimizing flow-related variables, has been demonstrated to have some clinical benefit and has been recommended by multiple professional societies. However, this approach has failed to achieve widespread adoption. A closed-loop Fluid administration system designed to assist anesthesia providers in consistently applying GDFT strategies has recently been developed and tested. Such an approach may change the crystalloid versus colloid debate. Because colloid solutions have a more profound effect on intravascular volume and longer plasma persistence, their use in this more “controlled” context could be associated with a lower Fluid balance, and potentially improved patient outcome. Additionally, most studies that have assessed the impact of a GDFT strategy on the outcome of high-risk surgical patients have used hydroxyethyl starch (HES) solutions in their protocols. Some of these studies have demonstrated beneficial effects, while none of them has reported severe complications. The type and volume of Fluid used for perioperative management need to be individualized according to the patient’s hemodynamic status and clinical condition. The amount of Fluid given should be guided by well-defined physiologic targets. Compliance with a predefined hemodynamic protocol may be optimized by using a computerized system. The type of Fluid should also be individualized, as should any drug Therapy, with careful consideration of timing and dose. It is our perspective that HES solutions remain a valid option for Fluid Therapy in the perioperative context because of their effects on blood volume and their reasonable benefit/risk profile.

  • crystalloid versus colloid for intraoperative goal directed Fluid Therapy using a closed loop system a randomized double blinded controlled trial in major abdominal surgery
    Anesthesiology, 2018
    Co-Authors: Alexandre Joosten, Amelie Delaporte, Brigitte Ickx, Karim Touihri, Ida Stany, Luc Barvais, Luc Van Obbergh, Patricia Loi, Joseph Rinehart, Maxime Cannesson
    Abstract:

    Background:The type of Fluid and volume regimen given intraoperatively both can impact patient outcome after major surgery. This two-arm, parallel, randomized controlled, double-blind, bi-center superiority study tested the hypothesis that when using closed-loop assisted goal-directed Fluid Therapy,

  • goal directed Fluid Therapy with closed loop assistance during moderate risk surgery using noninvasive cardiac output monitoring a pilot study
    BJA: British Journal of Anaesthesia, 2015
    Co-Authors: Maxime Cannesson, Alexandre Joosten, Trish Huynh, Cecilia Canales, Koichi Suehiro, Joseph Rinehart
    Abstract:

    Background. Goal directed Fluid Therapy (GDFT) has been shown to improve outcomes in moderate to high-risk surgery. However, most of the present GDFT protocols based on cardiac output optimization use invasive devices and the protocols may require significant practitioner attention and intervention to apply them accurately. The aim of this prospective pilot study was to evaluate the clinical feasibility of GDFT using a closed-loop Fluid administration system with a non-invasive cardiac output monitoring device (Nexfin TM , BMEYE, Amsterdam, Netherlands). Methods. Patients scheduled for elective moderate risk surgery under general anaesthesia were enrolled. The primary anaesthesia team managing the case selected GDFT targets using the controller interface and all patients received a baseline 3 ml kg 21 h 21 crystalloid infusion. Colloid solutions were delivered by the closed-loop system for intravascular volume expansion using data from the Nexfin TM monitor. Compliance with GDFT management was defined as acceptable when a patient spent more than 85% of the surgery time in a preload independent state (defined as pulse pressure variation ,13%) or when average cardiac index during surgery was .2.5 litre min 21 m 22 . Results. A total of 13 patients were included in the study group. All patients met the established criteria for delivery of GDFT for greater than 85% of case time. The median length of stay in the hospital was 5 [3‐6] days.

  • perioperative Fluid Therapy a statement from the international Fluid optimization group
    Perioperative medicine (London England), 2015
    Co-Authors: Lais Helena Camacho Navarro, Timothy E Miller, Joshua A Bloomstone, Jose Otavio Costa Auler, Maxime Cannesson, Giorgio Della Rocca, Tong J Gan, Michael P Kinsky, Sheldon Magder, M G Mythen
    Abstract:

    Perioperative Fluid Therapy remains a highly debated topic. Its purpose is to maintain or restore effective circulating blood volume during the immediate perioperative period. Maintaining effective circulating blood volume and pressure are key components of assuring adequate organ perfusion while avoiding the risks associated with either organ hypo- or hyperperfusion. Relative to perioperative Fluid Therapy, three inescapable conclusions exist: overhydration is bad, underhydration is bad, and what we assume about the Fluid status of our patients may be incorrect. There is wide variability of practice, both between individuals and institutions. The aims of this paper are to clearly define the risks and benefits of Fluid choices within the perioperative space, to describe current evidence-based methodologies for their administration, and ultimately to reduce the variability with which perioperative Fluids are administered. Based on the abovementioned acknowledgements, a group of 72 researchers, well known within the field of Fluid resuscitation, were invited, via email, to attend a meeting that was held in Chicago in 2011 to discuss perioperative Fluid Therapy. From the 72 invitees, 14 researchers representing 7 countries attended, and thus, the international Fluid Optimization Group (FOG) came into existence. These researches, working collaboratively, have reviewed the data from 162 different Fluid resuscitation papers including both operative and intensive care unit populations. This manuscript is the result of 3 years of evidence-based, discussions, analysis, and synthesis of the currently known risks and benefits of individual Fluids and the best methods for administering them. The results of this review paper provide an overview of the components of an effective perioperative Fluid administration plan and address both the physiologic principles and outcomes of Fluid administration. We recommend that both perioperative Fluid choice and Therapy be individualized. Patients should receive Fluid Therapy guided by predefined physiologic targets. Specifically, Fluids should be administered when patients require augmentation of their perfusion and are also volume responsive. This paper provides a general approach to Fluid Therapy and practical recommendations.

Alexandre Joosten - One of the best experts on this subject based on the ideXlab platform.

  • hydroxyethyl starch for perioperative goal directed Fluid Therapy in 2020 a narrative review
    BMC Anesthesiology, 2020
    Co-Authors: Bernd Saugel, Maxime Cannesson, Alexandre Joosten, Amelie Delaporte, Sean Coeckelenbergh, Brenton Alexander, J Duranteau, Jean Louis Vincent
    Abstract:

    Perioperative Fluid management – including the type, dose, and timing of administration –directly affects patient outcome after major surgery. The objective of Fluid administration is to optimize intravascular Fluid status to maintain adequate tissue perfusion. There is continuing controversy around the perioperative use of crystalloid versus colloid Fluids. Unfortunately, the importance of Fluid volume, which significantly influences the benefit-to-risk ratio of each chosen solution, has often been overlooked in this debate. The volume of Fluid administered during the perioperative period can influence the incidence and severity of postoperative complications. Regrettably, there is still huge variability in Fluid administration practices, both intra-and inter-individual, among clinicians. Goal-directed Fluid Therapy (GDFT), aimed at optimizing flow-related variables, has been demonstrated to have some clinical benefit and has been recommended by multiple professional societies. However, this approach has failed to achieve widespread adoption. A closed-loop Fluid administration system designed to assist anesthesia providers in consistently applying GDFT strategies has recently been developed and tested. Such an approach may change the crystalloid versus colloid debate. Because colloid solutions have a more profound effect on intravascular volume and longer plasma persistence, their use in this more “controlled” context could be associated with a lower Fluid balance, and potentially improved patient outcome. Additionally, most studies that have assessed the impact of a GDFT strategy on the outcome of high-risk surgical patients have used hydroxyethyl starch (HES) solutions in their protocols. Some of these studies have demonstrated beneficial effects, while none of them has reported severe complications. The type and volume of Fluid used for perioperative management need to be individualized according to the patient’s hemodynamic status and clinical condition. The amount of Fluid given should be guided by well-defined physiologic targets. Compliance with a predefined hemodynamic protocol may be optimized by using a computerized system. The type of Fluid should also be individualized, as should any drug Therapy, with careful consideration of timing and dose. It is our perspective that HES solutions remain a valid option for Fluid Therapy in the perioperative context because of their effects on blood volume and their reasonable benefit/risk profile.

  • hydroxyethyl starch for perioperative goal directed Fluid Therapy in 2020 a narrative review
    BMC Anesthesiology, 2020
    Co-Authors: Bernd Saugel, Maxime Cannesson, Alexandre Joosten, Amelie Delaporte, Sean Coeckelenbergh, Brenton Alexander, J Duranteau, Jean Louis Vincent
    Abstract:

    Background Perioperative Fluid management - including the type, dose, and timing of administration -directly affects patient outcome after major surgery. The objective of Fluid administration is to optimize intravascular Fluid status to maintain adequate tissue perfusion. There is continuing controversy around the perioperative use of crystalloid versus colloid Fluids. Unfortunately, the importance of Fluid volume, which significantly influences the benefit-to-risk ratio of each chosen solution, has often been overlooked in this debate. Main text The volume of Fluid administered during the perioperative period can influence the incidence and severity of postoperative complications. Regrettably, there is still huge variability in Fluid administration practices, both intra-and inter-individual, among clinicians. Goal-directed Fluid Therapy (GDFT), aimed at optimizing flow-related variables, has been demonstrated to have some clinical benefit and has been recommended by multiple professional societies. However, this approach has failed to achieve widespread adoption. A closed-loop Fluid administration system designed to assist anesthesia providers in consistently applying GDFT strategies has recently been developed and tested. Such an approach may change the crystalloid versus colloid debate. Because colloid solutions have a more profound effect on intravascular volume and longer plasma persistence, their use in this more "controlled" context could be associated with a lower Fluid balance, and potentially improved patient outcome. Additionally, most studies that have assessed the impact of a GDFT strategy on the outcome of high-risk surgical patients have used hydroxyethyl starch (HES) solutions in their protocols. Some of these studies have demonstrated beneficial effects, while none of them has reported severe complications. Conclusions The type and volume of Fluid used for perioperative management need to be individualized according to the patient's hemodynamic status and clinical condition. The amount of Fluid given should be guided by well-defined physiologic targets. Compliance with a predefined hemodynamic protocol may be optimized by using a computerized system. The type of Fluid should also be individualized, as should any drug Therapy, with careful consideration of timing and dose. It is our perspective that HES solutions remain a valid option for Fluid Therapy in the perioperative context because of their effects on blood volume and their reasonable benefit/risk profile.

  • crystalloid versus colloid for intraoperative goal directed Fluid Therapy using a closed loop system a randomized double blinded controlled trial in major abdominal surgery
    Anesthesiology, 2018
    Co-Authors: Alexandre Joosten, Amelie Delaporte, Brigitte Ickx, Karim Touihri, Ida Stany, Luc Barvais, Luc Van Obbergh, Patricia Loi, Joseph Rinehart, Maxime Cannesson
    Abstract:

    Background:The type of Fluid and volume regimen given intraoperatively both can impact patient outcome after major surgery. This two-arm, parallel, randomized controlled, double-blind, bi-center superiority study tested the hypothesis that when using closed-loop assisted goal-directed Fluid Therapy,

  • goal directed Fluid Therapy with closed loop assistance during moderate risk surgery using noninvasive cardiac output monitoring a pilot study
    BJA: British Journal of Anaesthesia, 2015
    Co-Authors: Maxime Cannesson, Alexandre Joosten, Trish Huynh, Cecilia Canales, Koichi Suehiro, Joseph Rinehart
    Abstract:

    Background. Goal directed Fluid Therapy (GDFT) has been shown to improve outcomes in moderate to high-risk surgery. However, most of the present GDFT protocols based on cardiac output optimization use invasive devices and the protocols may require significant practitioner attention and intervention to apply them accurately. The aim of this prospective pilot study was to evaluate the clinical feasibility of GDFT using a closed-loop Fluid administration system with a non-invasive cardiac output monitoring device (Nexfin TM , BMEYE, Amsterdam, Netherlands). Methods. Patients scheduled for elective moderate risk surgery under general anaesthesia were enrolled. The primary anaesthesia team managing the case selected GDFT targets using the controller interface and all patients received a baseline 3 ml kg 21 h 21 crystalloid infusion. Colloid solutions were delivered by the closed-loop system for intravascular volume expansion using data from the Nexfin TM monitor. Compliance with GDFT management was defined as acceptable when a patient spent more than 85% of the surgery time in a preload independent state (defined as pulse pressure variation ,13%) or when average cardiac index during surgery was .2.5 litre min 21 m 22 . Results. A total of 13 patients were included in the study group. All patients met the established criteria for delivery of GDFT for greater than 85% of case time. The median length of stay in the hospital was 5 [3‐6] days.

  • closed loop assisted versus manual goal directed Fluid Therapy during high risk abdominal surgery a case control study with propensity matching
    Critical Care, 2015
    Co-Authors: Joseph Rinehart, Alexandre Joosten, Marc Lilot, Trish Huynh, Cecilia Canales, David K Imagawa, Aram N Demirjian, Maxime Cannesson
    Abstract:

    Goal-directed Fluid Therapy strategies have been shown to benefit moderate- to high-risk surgery patients. Despite this, these strategies are often not implemented. The aim of this study was to assess a closed-loop Fluid administration system in a surgical cohort and compare the results with those for matched patients who received manual management. Our hypothesis was that the patients receiving closed-loop assistance would spend more time in a preload-independent state, defined as percentage of case time with stroke volume variation less than or equal to 12%. Patients eligible for the study were all those over 18 years of age scheduled for hepatobiliary, pancreatic or splenic surgery and expected to receive intravascular arterial blood pressure monitoring as part of their anesthetic care. The closed-loop resuscitation target was selected by the primary anesthesia team, and the system was responsible for implementation of goal-directed Fluid Therapy during surgery. Following completion of enrollment, each study patient was matched to a non–closed-loop assisted case performed during the same time period using a propensity match to reduce bias. A total of 40 patients were enrolled, 5 were ultimately excluded and 25 matched pairs were selected from among the remaining 35 patients within the predefined caliper distance. There was no significant difference in Fluid administration between groups. The closed-loop group spent a significantly higher portion of case time in a preload-independent state (95 ± 6% of case time versus 87 ± 14%, P =0.008). There was no difference in case mean or final stroke volume index (45 ± 10 versus 43 ± 9 and 45 ± 11 versus 42 ± 11, respectively) or mean arterial pressure (79 ± 8 versus 83 ± 9). Case end heart rate was significantly lower in the closed-loop assisted group (77 ± 10 versus 88 ± 13, P =0.003). In this case–control study with propensity matching, clinician use of closed-loop assistance resulted in a greater portion of case time spent in a preload-independent state throughout surgery compared with manual delivery of goal-directed Fluid Therapy. ClinicalTrials.gov Identifier: NCT02020863 . Registered 19 December 2013

Michael Joannidis - One of the best experts on this subject based on the ideXlab platform.

  • protocol and statistical analysis plan for the restricted Fluid Therapy versus standard treatment in acute kidney injury reverse aki randomized controlled pilot trial
    Acta Anaesthesiologica Scandinavica, 2020
    Co-Authors: Eric Hoste, Suvi T Vaara, Marlies Ostermann, Tuomas Selander, Laurent Bitker, Antoine G Schneider, Elettra Poli, Michael Joannidis
    Abstract:

    Background Fluid accumulation frequently coexists with acute kidney injury (AKI) and is associated with increased risk for AKI progression and mortality. Among septic shock patients, restricted use of resuscitation Fluid has been reported to reduce the risk of worsening of AKI. Restrictive Fluid Therapy, however, has not been studied in the setting of established AKI. Here, we present the protocol and statistical analysis plan of the REstricted Fluid Therapy VERsus Standard trEatment in Acute Kidney Injury-the REVERSE-AKI trial that compares a restrictive Fluid Therapy regimen to standard Therapy in critically ill patients with AKI. Methods REVERSE-AKI is an investigator-initiated, multinational, open-label, randomized, controlled, feasibility pilot trial conducted in seven ICUs in five countries. We aim to randomize 100 critically ill patients with AKI to a restrictive Fluid treatment regimen vs standard management. In the restrictive Fluid Therapy regimen, the daily Fluid balance target is neutral or negative. The primary outcome is the cumulative Fluid balance assessed after 72 hours from randomization. Secondary outcomes include safety, feasibility, duration, and severity of AKI, and outcome at 90 days (mortality and dialysis dependence). Conclusions This is the first multinational trial investigating the feasibility and safety of a restrictive Fluid Therapy regimen in critically ill patients with AKI. Trial registration clinical.trials.gov NCT03251131.

Rinaldo Bellomo - One of the best experts on this subject based on the ideXlab platform.

  • liberal versus restrictive intravenous Fluid Therapy for early septic shock rationale for a randomized trial
    Annals of Emergency Medicine, 2018
    Co-Authors: Wesley H Self, Rinaldo Bellomo, Matthew W Semler, Samuel M Brown, Bennett P Deboisblanc, Matthew C Exline, Adit A Ginde, Colin K Grissom, David R Janz, Alan E Jones
    Abstract:

    Prompt intravenous Fluid Therapy is a fundamental treatment for patients with septic shock. However, the optimal approach for administering intravenous Fluid in septic shock resuscitation is unknown. Two competing strategies are emerging: a liberal Fluids approach, consisting of a larger volume of initial Fluid (50 to 75 mL/kg [4 to 6 L in an 80-kg adult] during the first 6 hours) and later use of vasopressors, versus a restrictive Fluids approach, consisting of a smaller volume of initial Fluid (≤30 mL/kg [≤2 to 3 L]), with earlier reliance on vasopressor infusions to maintain blood pressure and perfusion. Early Fluid Therapy may enhance or maintain tissue perfusion by increasing venous return and cardiac output. However, Fluid administration may also have deleterious effects by causing edema within vital organs, leading to organ dysfunction and impairment of oxygen delivery. Conversely, a restrictive Fluids approach primarily relies on vasopressors to reverse hypotension and maintain perfusion while limiting the administration of Fluid. Both strategies have some evidence to support their use but lack robust data to confirm the benefit of one strategy over the other, creating clinical and scientific equipoise. As part of the National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury Network, we designed a randomized clinical trial to compare the liberal and restrictive Fluids strategies, the Crystalloid Liberal or Vasopressor Early Resuscitation in Sepsis trial. The purpose of this article is to review the current literature on approaches to early Fluid resuscitation in adults with septic shock and outline the rationale for the upcoming trial.

  • intravenous Fluid Therapy in critically ill adults
    Nature Reviews Nephrology, 2018
    Co-Authors: Simon Finfer, John Myburgh, Rinaldo Bellomo
    Abstract:

    Intravenous Fluid Therapy is one of the most common interventions in acutely ill patients. Each day, over 20% of patients in intensive care units (ICUs) receive intravenous Fluid resuscitation, and more than 30% receive Fluid resuscitation during their first day in the ICU. Virtually all hospitalized patients receive intravenous Fluid to maintain hydration and as diluents for drug administration. Until recently, the amount and type of Fluids administered were based on a theory described over 100 years ago, much of which is inconsistent with current physiological data and emerging knowledge. Despite their widespread use, various Fluids for intravenous administration have entered clinical practice without a robust evaluation of their safety and efficacy. High-quality, investigator-initiated studies have revealed that some of these Fluids have unacceptable toxicity; as a result, several have been withdrawn from the market (while others, controversially, are still in use). The belief that dehydration and hypovolaemia can cause or worsen kidney and other vital organ injury has resulted in liberal approaches to Fluid Therapy and the view that Fluid overload and tissue oedema are 'normal' during critical illness; this is quite possibly harming patients. Increasing evidence indicates that restrictive Fluid strategies might improve outcomes.

  • effect of 0 9 saline or plasma lyte 148 as crystalloid Fluid Therapy in the intensive care unit on blood product use and postoperative bleeding after cardiac surgery
    Journal of Cardiothoracic and Vascular Anesthesia, 2017
    Co-Authors: Sumeet K Reddy, Rinaldo Bellomo, Michael Bailey, Richard Beasley, Diane Mackle, Alex Psirides, Paul J Young
    Abstract:

    Objective To evaluate the effect of Plasma-Lyte 148 (PL-148) compared with 0.9% saline (saline) on blood product use and postoperative bleeding in patients admitted to the intensive care unit (ICU) following cardiac surgery. Design A post hoc subgroup analysis conducted within a multicenter, double-blind, cluster-randomized, double-crossover study (study 1) and a prospective, single-center nested-cohort study (study 2). Setting Tertiary-care hospitals. Participants Adults admitted to the ICU after cardiac surgery requiring crystalloid Fluid Therapy as part of the 0.9% saline vs. PL-148 for ICU Fluid Therapy (SPLIT) trial. Interventions Blinded saline or PL-148 for 4 alternating 7-week blocks. Measurements and Main Results 954 patients were included in study 1; 475 patients received PL-148, and 479 received saline. 128 of 475 patients (26.9%) in the PL-148 group received blood or a blood product compared with 94 of 479 patients (19.6%) in the saline group (OR [95% confidence interval], 1.51 [1.11-2.05]; p = 0.008). In study 2, 131 patients were allocated to PL-148 and 120 patients were allocated to saline. There were no differences between groups in chest drain output from the time of arrival in the ICU until 12 hours postoperatively (geometric mean, 566 mL for the PL-148 group v 547 mL in the saline group; p = 0.60). Conclusions The findings did not support the hypothesis that using PL-148 for Fluid Therapy in ICU following cardiac surgery reduces transfusion requirements compared to saline. The significantly increased proportion of patients receiving blood or blood product with allocation to PL-148 compared to saline was unexpected and requires verification through further research.

  • the plasma lyte 148 v saline plus study protocol a multicentre randomised controlled trial of the effect of intensive care Fluid Therapy on mortality
    Critical Care and Resuscitation, 2017
    Co-Authors: Naomi Hammond, John Myburgh, Rinaldo Bellomo, Diane Mackle, Martin Gallagher, David Gattas, Parisa Glass, Sharon Micallef, Manoj Saxena, Colman Taylor
    Abstract:

    Background: 0.9% sodium chloride (saline) is the most commonly administered resuscitation Fluid on a global basis but emerging evidence suggests that its high chloride content may have important adverse effects. Objective: To describe the study protocol for the Plasma- Lyte 148 v Saline study, which will test the hypothesis that in critically ill adult patients the use of Plasma-Lyte 148 (a buffered crystalloid solution) for Fluid Therapy results in different 90-day all-cause mortality when compared with saline. Design and setting: We will conduct this multicentre, blinded, randomised controlled trial in approximately 50 intensive care units in Australia and New Zealand. We will randomly assign 8800 patients to either Plasma-Lyte 148 or saline for all resuscitation Fluid, maintenance Fluid and compatible drug dilution Therapy while in the ICU for up to 90 days after randomisation. Outcome measures: The primary outcome is 90-day all-cause mortality; secondary outcomes include mean and peak creatinine concentration, incidence of renal replacement Therapy, incidence and duration of vasoactive drug treatment, duration of mechanical ventilation, ICU and hospital length of stay, and quality of life and health services use at 6 months. Results and conclusions: The PLUS study will provide high-quality data on the comparative safety and efficacy of Plasma-Lyte 148 compared with saline for resuscitation and compatible crystalloid Fluid Therapy in critically ill adult patients.

  • a rational approach to Fluid Therapy in sepsis
    Survey of Anesthesiology, 2016
    Co-Authors: Paul E Marik, Rinaldo Bellomo
    Abstract:

    Aggressive Fluid resuscitation to achieve a central venous pressure (CVP) greater than 8 mm Hg has been promoted as the standard of care, in the management of patients with severe sepsis and septic shock. However recent clinical trials have demonstrated that this approach does not improve the outcome of patients with severe sepsis and septic shock. Pathophysiologically, sepsis is characterized by vasoplegia with loss of arterial tone, venodilation with sequestration of blood in the unstressed blood compartment and changes in ventricular function with reduced compliance and reduced preload responsiveness. These data suggest that sepsis is primarily not a volume-depleted state and recent evidence demonstrates that most septic patients are poorly responsive to Fluids. Furthermore, almost all of the administered Fluid is sequestered in the tissues, resulting in severe oedema in vital organs and, thereby, increasing the risk of organ dysfunction. These data suggest that a physiologic, haemodynamically guided conservative approach to Fluid Therapy in patients with sepsis would be prudent and would likely reduce the morbidity and improve the outcome of this disease.