Dataset Information

Restrictive versus Liberal Fluid Therapy for Post-Cesarean Acute Kidney Injury in Severe Preeclampsia: a Pilot Randomized Clinical Trial.

ABSTRACT: OBJECTIVES:The aim of this study was to determine whether a restrictive compared to a liberal fluid therapy will increase postoperative acute kidney injury (AKI) in patients with severe preeclampsia. METHODS:A total of 46 patients (mean age, 32 years; standard deviation, 6.8 years) with severe preeclampsia were randomized to liberal (1500 ml of lactated Ringer's, n=23) or restrictive (250 ml of lactated Ringer's, n=23) intravenous fluid regimen during cesarean section. The primary outcome was the development of a postoperative renal dysfunction defined by AKI Network stage ?1. Serum cystatin C and neutrophil gelatinase-associated lipocalin (NGAL) were evaluated at postoperative days 1 and 2. ClinicalTrials.gov: NCT02214186. RESULTS:The rate of postoperative AKI was 43.5% in the liberal fluid group and 43.5% in the restrictive fluid group (p=1.0). Intraoperative urine output was higher in the liberal (116 ml/h, IQR 69-191) than in the restrictive fluid group (80 ml/h, IQR 37-110, p<0.05). In both groups, serum cystatin C did not change from postoperative day 1 compared to the preoperative period and significantly decreased on postoperative day 2 compared to postoperative day 1 (p<0.05). In the restrictive fluid group, NGAL levels increased on postoperative day 1 compared to the preoperative period (p<0.05) and decreased on postoperative day 2 compared to postoperative day 1 (p<0.05). CONCLUSION:Among patients with severe preeclampsia, a restrictive fluid regimen during cesarean section was not associated with increased postoperative AKI.

SUBMITTER: Silva WAD

PROVIDER: S-EPMC7362722 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Restrictive versus Liberal Fluid Therapy for Post-Cesarean Acute Kidney Injury in Severe Preeclampsia: a Pilot Randomized Clinical Trial.

Silva Wallace Andrino da WAD Varela Carlo Victor A CVA Pinheiro Aline Macedo AM Scherer Paula Castro PC Francisco Rossana P V RPV Torres Marcelo Luis Abramides MLA Carmona Maria José C MJC Bliacheriene Fernando F Andrade Lúcia C LC Pelosi Paolo P Malbouisson Luiz Marcelo S LMS

Clinics (Sao Paulo, Brazil) 20200722

<h4>Objectives</h4>The aim of this study was to determine whether a restrictive compared to a liberal fluid therapy will increase postoperative acute kidney injury (AKI) in patients with severe preeclampsia.<h4>Methods</h4>A total of 46 patients (mean age, 32 years; standard deviation, 6.8 years) with severe preeclampsia were randomized to liberal (1500 ml of lactated Ringer's, n=23) or restrictive (250 ml of lactated Ringer's, n=23) intravenous fluid regimen during cesarean section. The primary ...[more]

PMID: 32725073

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Project description:IntroductionObservational studies have linked slower and faster net ultrafiltration (UFNET) rates during kidney replacement therapy (KRT) with mortality in critically ill patients with acute kidney injury (AKI) and fluid overload. To inform the design of a larger randomised trial of patient-centered outcomes, we conduct a feasibility study to examine restrictive and liberal approaches to UFNET during continuous KRT (CKRT).Methods and analysisThis study is an investigator-initiated, unblinded, 2-arm, comparative-effectiveness, stepped-wedged, cluster randomised trial among 112 critically ill patients with AKI treated with CKRT in 10 intensive care units (ICUs) across 2 hospital systems. In the first 6 months, all ICUs started with a liberal UFNET rate strategy. Thereafter, one ICU is randomised to the restrictive UFNET rate strategy every 2 months. In the liberal group, the UFNET rate is maintained between 2.0 and 5.0 mL/kg/hour; in the restrictive group, the UFNET rate is maintained between 0.5 and 1.5 mL/kg/hour. The three coprimary feasibility outcomes are (1) between-group separation in mean delivered UFNET rates; (2) protocol adherence; and (3) patient recruitment rate. Secondary outcomes include daily and cumulative fluid balance, KRT and mechanical ventilation duration, organ failure-free days, ICU and hospital length of stay, hospital mortality and KRT dependence at hospital discharge. Safety endpoints include haemodynamics, electrolyte imbalance, CKRT circuit issues, organ dysfunction related to fluid overload, secondary infections and thrombotic and haematological complications.Ethics and disseminationThe University of Pittsburgh Human Research Protection Office approved the study, and an independent Data and Safety Monitoring Board monitors the study. A grant from the United States National Institute of Diabetes and Digestive and Kidney Diseases sponsors the study. The trial results will be submitted for publication in peer-reviewed journals and presented at scientific conferences.Trial registration numberThis trial has been prospectively registered with clinicaltrials.gov (NCT05306964). Protocol version identifier and date: 1.5; 13 June 2023.

Project description:Liberal fluid strategies in critically ill patients are associated with harm, thought to be due to endothelial and glycocalyx injury. As the restrictive versus liberal fluid therapy for major abdominal surgery trial not only failed to report survival benefit with restrictive fluids but was associated with a higher rate of acute kidney injury, we hypothesized that factors other than endothelial and glycocalyx injury were likely to account for these findings. Consequently, we measured injury biomarkers in a cohort of the restrictive versus liberal fluid therapy for major abdominal surgery trial.DesignThe restrictive versus liberal fluid therapy for major abdominal surgery trial was an international, randomized, assessor-blinded trial comparing restrictive with liberal IV fluid regimens that represented traditional care in patients undergoing major abdominal surgery.Setting and patientsCohort of restrictive versus liberal fluid therapy for major abdominal surgery bloods was collected at a single major site (161 patients) prior to, day 1 and day 3 after surgery.InterventionBloods were blindly and randomly batch analyzed for plasma markers of endothelial/glycocalyx injury-angiopoietin-1, angiopoietin-2, soluble tyrosine-protein kinase-2 receptor, soluble intracellular adhesion molecule-1, syndecan, and tumor necrosis factor-α. Data were examined as restrictive versus liberal enrollment groups and high versus low (± 5,000 mL) fluid groups. Differences were examined by linear mixed modeling.Measurement and main resultsThere were no significant differences in any biomarkers between the restrictive (n = 75) and liberal (n = 86) groups. When examined as low (n = 81) and high (n = 79) fluid groups, plasma angiopoietin-2 (p = 0.009) and soluble intracellular adhesion molecule-1 (p = 0.01) were elevated in the high fluid group. There were no differences in other biomarkers.ConclusionsAlthough these results are consistent with previous findings of vascular injury following liberal fluid therapy, they suggest alternative mechanisms underlie the clinical outcomes from restrictive versus liberal fluid therapy for major abdominal surgery study.Clinicaltrialsgov identifierNCT01424150.

Project description:BackgroundIntravenous (IV) fluid therapy is essential in the treatment of critically ill pediatric surgery and trauma patients. Recent studies have suggested that aggressive fluids may be detrimental to patients. Prospective studies are needed to compare liberal to restricted fluid management in these patients. The primary objective of this pilot trial is to test study feasibility-recruitment and adherence to the study treatment algorithm.MethodsWe conducted a two-part pilot randomized controlled trial (RCT) comparing liberal to restricted crystalloid fluid management in 50 pediatric post-operative (1-18 years) and trauma (1-15 years) patients admitted to our pediatric intensive care unit (PICU). Patients were randomized to a high (liberal) volume or low (restricted) volume algorithm using unblinded, blocked randomization. A revised treatment algorithm was used after the 29th patient for the second part of the RCT. The goal of the trial was to determine the feasibility of conducting an RCT at a single site for recruitment and retention. We also collected data on the safety of study interventions and clinical outcomes, including pulmonary, infectious, renal, post-operative, and length of stay outcomes.ResultsFifty patients were randomized to either liberal (n = 26) or restricted (n = 24) fluid management strategy. After data was obtained on 29 patients, a first study analysis was performed. The volume of fluid administered and triggers for intervention were adapted to optimize the treatment effect and clarity of outcomes. Updated and refined fluid management algorithms were created. These were used for the second part of the RCT on patients 30-50. During this second study period, 54% (21/39, 95% CI 37-70%) of patients approached were enrolled in the study. Of the patients enrolled, 71% (15/21, 95% CI 48-89%) completed the study. This met our a priori recruitment and retention criteria for success. A data safety monitoring committee concluded that no adverse events were related to study interventions. Although the study was not powered to detect differences in outcomes, after the algorithm was revised, we observed a non-significant trend towards improved pulmonary outcomes in patients on the restricted arm, including decreased need for and time on oxygen support and decreased need for mechanical ventilation.ConclusionWe demonstrated the feasibility and safety of conducting a single-site RCT comparing liberal to restricted crystalloid fluid management in critically ill pediatric post-operative and trauma patients. We observed trends in improved pulmonary outcomes in patients undergoing restricted fluid management. A definitive multicenter RCT comparing fluid management strategies in these patients is warranted.Trial registrationClinicalTrials.gov, NCT04201704 . Registered 17 December 2019-retrospectively registered.

Project description:BackgroundIntravenous fluids and vasopressor agents are commonly used in early resuscitation of patients with sepsis, but comparative data for prioritizing their delivery are limited.MethodsIn an unblinded superiority trial conducted at 60 U.S. centers, we randomly assigned patients to either a restrictive fluid strategy (prioritizing vasopressors and lower intravenous fluid volumes) or a liberal fluid strategy (prioritizing higher volumes of intravenous fluids before vasopressor use) for a 24-hour period. Randomization occurred within 4 hours after a patient met the criteria for sepsis-induced hypotension refractory to initial treatment with 1 to 3 liters of intravenous fluid. We hypothesized that all-cause mortality before discharge home by day 90 (primary outcome) would be lower with a restrictive fluid strategy than with a liberal fluid strategy. Safety was also assessed.ResultsA total of 1563 patients were enrolled, with 782 assigned to the restrictive fluid group and 781 to the liberal fluid group. Resuscitation therapies that were administered during the 24-hour protocol period differed between the two groups; less intravenous fluid was administered in the restrictive fluid group than in the liberal fluid group (difference of medians, -2134 ml; 95% confidence interval [CI], -2318 to -1949), whereas the restrictive fluid group had earlier, more prevalent, and longer duration of vasopressor use. Death from any cause before discharge home by day 90 occurred in 109 patients (14.0%) in the restrictive fluid group and in 116 patients (14.9%) in the liberal fluid group (estimated difference, -0.9 percentage points; 95% CI, -4.4 to 2.6; P = 0.61); 5 patients in the restrictive fluid group and 4 patients in the liberal fluid group had their data censored (lost to follow-up). The number of reported serious adverse events was similar in the two groups.ConclusionsAmong patients with sepsis-induced hypotension, the restrictive fluid strategy that was used in this trial did not result in significantly lower (or higher) mortality before discharge home by day 90 than the liberal fluid strategy. (Funded by the National Heart, Lung, and Blood Institute; CLOVERS ClinicalTrials.gov number, NCT03434028.).

Project description:BackgroundPostoperative complications impact on early and long-term patients' outcome. Appropriate perioperative fluid management is pivotal in this context; however, the most effective perioperative fluid management is still unclear. The enhanced recovery after surgery pathways recommend a perioperative zero-balance, whereas recent findings suggest a more liberal approach could be beneficial. We conducted this trial to address the impact of restrictive vs. liberal fluid approaches on overall postoperative complications and mortality.MethodsSystematic review and meta-analysis, including randomised controlled trials (RCTs). We performed a systematic literature search using MEDLINE (via Ovid), EMBASE (via Ovid) and the Cochrane Controlled Clinical trials register databases, published from 1 January 2000 to 31 December 2019. We included RCTs enrolling adult patients undergoing elective abdominal surgery and comparing the use of restrictive/liberal approaches enrolling at least 15 patients in each subgroup. Studies involving cardiac, non-elective surgery, paediatric or obstetric surgeries were excluded.ResultsAfter full-text examination, the metanalysis finally included 18 studies and 5567 patients randomised to restrictive (2786 patients; 50.0%) or liberal approaches (2780 patients; 50.0%). We found no difference in the occurrence of severe postoperative complications between restrictive and liberal subgroups [risk difference (95% CI) = 0.009 (- 0.02; 0.04); p value = 0.62; I2 (95% CI) = 38.6% (0-66.9%)]. This result was confirmed also in the subgroup of five studies having a low overall risk of bias. The liberal approach was associated with lower overall renal major events, as compared to the restrictive [risk difference (95% CI) = 0.06 (0.02-0.09); p value = 0.001]. We found no difference in either early (p value = 0.33) or late (p value = 0.22) postoperative mortality between restrictive and liberal subgroups CONCLUSIONS: In major abdominal elective surgery perioperative, the choice between liberal or restrictive approach did not affect overall major postoperative complications or mortality. In a subgroup analysis, a liberal as compared to a restrictive perioperative fluid policy was associated with lower overall complication renal major events, as compared to the restrictive.Trial registrationCRD42020218059; Registration: February 2020, https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=218059 .

Dataset Information

Restrictive versus Liberal Fluid Therapy for Post-Cesarean Acute Kidney Injury in Severe Preeclampsia: a Pilot Randomized Clinical Trial.

Publications

Restrictive versus Liberal Fluid Therapy for Post-Cesarean Acute Kidney Injury in Severe Preeclampsia: a Pilot Randomized Clinical Trial.

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