Dataset Information

Goal-directed perfusion to reduce acute kidney injury after paediatric cardiac surgery (GDP-AKIp): study protocol for a prospective randomised controlled trial.

ABSTRACT:

Introduction

Cardiac surgery-associated acute kidney injury (CS-AKI) occurs in up to 40%~60% of paediatric patients and increases postoperative morbidity and mortality. A goal-directed perfusion (GDP) strategy aimed at maintaining indexed oxygen delivery (DO₂i) above the critical threshold (reported to be 260~300?mL/min/m² in adults) during cardiopulmonary bypass (CPB), is effective in reducing the incidence of CS-AKI. However, no clear standards of paediatric critical DO₂i exist. Our prior prospective cohort study exploring the critical DO₂i threshold during paediatric CPB has found the nadir DO₂i <353 mL/min/m² was an independent risk predictor of CS-AKI. Based on this background, this trial is designed to further determine whether the implementation of the GDP initiative aimed at maintaining DO₂i ?360?mL/min/m² would reduce the rate of CS-AKI in paediatrics and improve clinical outcome.

Methods and analysis

This is a prospective, single-centre, randomised controlled trial. In total, 166 paediatric patients undergoing cardiac surgery will be randomly allocated to the GDP group or control group. Patients in the GDP arm will be treated with a GDP strategy during CPB aimed to maintain DO₂i at ?360?mL/min/m² (to ensure safely above the risk DO₂i threshold we found). The perfusion strategy for patients in the control arm will be factored on body surface area and temperature. The primary outcome is the rate of postoperative CS-AKI (it is defined according to paediatric Risk, Injury, Failure, Loss of renal function and End-stage renal disease criteria). The secondary end points include: (1) the other oxygen metabolism parameters during CPB; (2) major complication and all-cause mortality (in-hospital or within 30 days postoperatively); (3) short-term clinical outcomes (ie, time to extubation, mechanical ventilation time, hospital stay).

Ethics and dissemination

The study has been approved by the Biomedical Research Ethics committee of West China Hospital of Sichuan University (approval number: 2019(863)). Results will be disseminated through peer-reviewed publications and conferences.

Trial registration number

ChiCTR2000029232.

SUBMITTER: Zhang Y

PROVIDER: S-EPMC7733190 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Goal-directed perfusion to reduce acute kidney injury after paediatric cardiac surgery (GDP-AKIp): study protocol for a prospective randomised controlled trial.

Zhang Yan Y Zhou Xiujuan X Wang Bo B Guo Lijuan L Zhou Ronghua R

BMJ open 20201210 12

<h4>Introduction</h4>Cardiac surgery-associated acute kidney injury (CS-AKI) occurs in up to 40%~60% of paediatric patients and increases postoperative morbidity and mortality. A goal-directed perfusion (GDP) strategy aimed at maintaining indexed oxygen delivery (DO<sub>2</sub>i) above the critical threshold (reported to be 260~300 mL/min/m<sup>2</sup> in adults) during cardiopulmonary bypass (CPB), is effective in reducing the incidence of CS-AKI. However, no clear standards of paediatric criti ...[more]

PMID: 33303444

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Project description:In cardiovascular surgery, reduced organ perfusion and oxygen delivery contribute to increased postoperative morbidity and prolonged intensive care unit stay. Goal-directed therapy (GDT), a perioperative haemodynamic strategy aiming to increase cardiac output, is helpful in preventing postoperative complications, but studies in the context of cardiovascular surgery have produced conflicting results. The purpose of the present meta-analysis is to determine the effects of perioperative haemodynamic goal-directed therapy on mortality and morbidity in cardiac and vascular surgery. MEDLINE, EMBASE, The Cochrane Library and the DARE databases were searched until July 2011. Randomized controlled trials reporting on adult cardiac or vascular surgical patients managed with perioperative GDT or according to routine haemodynamic practice were included. Primary outcome measures were mortality and morbidity. Data synthesis was obtained by using odds ratio (OR) with 95% confidence interval (CI) by a random effects model. An OR <1 favoured GDT. Statistical heterogeneity was assessed by Q and I(2) statistics. Eleven articles (five cardiac surgery and six vascular procedures), enrolling a total sample of 1179 patients, were included in the analysis. As compared with routine haemodynamic practice, perioperative GDT did not reduce mortality in either cardiac or vascular surgery (pooled OR 0.87; 95% CI 0.37-2.02; statistical power 64%). GDT significantly reduced the number of cardiac patients with complications (OR 0.34; 95% CI 0.18-0.63; P = 0.0006), but no effect was observed in vascular patients (OR, 0.84; 95% CI 0.45-1.56; P = 0.58). Perioperative GDT prevents postoperative complications in cardiac surgery patients, while it has no effect in vascular surgery. The different characteristics and comorbidities of the population enrolled could explain these conflicting results. More trials conforming to the characteristics of low-risk-of-bias studies and enrolling a larger and well-defined population of patients are needed to better clarify the effect of GDT in the specific setting of cardiovascular surgery.

Project description:BackgroundPerioperative goal-directed fluid therapy (GDFT) aiming to maintain individual fluid balance based on sensitive parameters was prevalent in major surgery, especially in enhanced recovery after surgery (ERAS) pathway. This meta-analysis was conducted for the purpose of evaluating whether GDFT impacts on occurrence of postoperative ileus and whether its application is worthwhile in gastrointestinal surgery.MethodsA systematic search of RCTs compared GDFT with other fluid management in patients undergoing gastrointestinal surgery from the PubMed, Web of Science, Embase, Cochrane Library databases was implemented. The primary outcome is incidence of postoperative ileus. Other outcome measures were length of hospital stay (LOS), postoperative morbidity and mortality. Subgroup analysis was planed a prior to verify the definite role of GDFT.Results12 trials consisted of 1836 patients were included in the final analysis. GDFT did not influence the occurrence of postoperative ileus (relative risk, RR 0.71, 95% confidence interval, CI 0.47-1.07, P?=?.10), with moderate heterogeneity (I?=?29%, P?=?.16). No difference was found between GDFT and control groups in LOS (mean difference -0.17 days, 95% CI -0.73 to 0.39, P?=?.55), total complication rate (RR 0.92, 95% CI 0.81-1.05, P?=?.23), and 30-day mortality (RR 0.91, 95% CI 0.47-1.75, P?=?.77). In other secondary outcomes, only wound infection rate was lower in the GDFT group (RR 0.68, 95% CI 0.50-0.93, P?=?.02). When performed subgroup analysis, GDFT was superior in reduction ileus only when compared with standard therapy or in those outside ERAS.ConclusionsIt is possible that GDFT dose not affect the occurrence of postoperative ileus in gastrointestinal surgery. It scarcely influences postoperative morbidity and mortality as well. However, lower incidence of ileus is observed in GDFT group either outside ERAS or compared with standard fluid therapy. Probably, GDFT may not be necessary in the ERAS pathway or if a hybrid approach is adopted.

Project description:BackgroundEarly goal-directed therapy (EGDT) has become an important therapeutic management in early salvage stage of septic shock. However, splenic organs possibly remained hypoperfused and hypoxic despite fluid resuscitation. This study aimed to evaluate the effect of EGDT on hepatic perfusion in septic shock patients.MethodsA prospective observational study was carried out in early septic shock patients who were admitted to Intensive Care Unit within 24 h after onset and who met all four elements of the EGDT criteria after treatment with the standard EGDT procedure within 6 h between December 1, 2012 and November 30, 2013. The hemodynamic data were recorded, and oxygen metabolism and hepatic functions were monitored. An indocyanine green clearance test was applied to detect the hepatic perfusion. The patients' characteristics were compared before treatment (T0), immediately after EGDT (T1), and 24 h after EGDT (T2). This study is registered at ClinicalTrials.org, NCT02060773.ResultsTwenty-one patients were included in the study; however, the hepatic perfusion data were not included in the analysis for two patients; therefore, 19 patients were eligible for the study. Hemodynamics data, as monitored by pulse-indicator continuous cardiac output, were obtained from 16 patients. There were no significant differences in indocyanine green plasma disappearance rate (ICG-PDR) and 15-min retention rate (R15) at T0 (11.9 ± 5.0%/min and 20.0 ± 13.2%), T1 (11.4 ± 5.1%/min and 23.6 ± 14.9%), and T2 (11.0 ± 4.5%/min and 23.7 ± 15.3%) (all P > 0.05). Both of the alterations of ICG-PDR and R15 showed no differences at T0, T1, and T2 in the patients of different subgroups that achieved different resuscitation goal numbers when elected (P > 0.05).ConclusionThere were no hepatic perfusion improvements after EGDT in the early phase of patients with septic shock.Trial registrationClinicaltrials.gov NCT02060773 (https://clinicaltrials.gov/ct2/show/NCT02060773).

Project description:IntroductionIntravenous fluid therapy during gastrointestinal surgery is a life-saving part of the perioperative care. Too little fluid may lead to hypovolaemia, decreased organ perfusion and circulatory shock. Excessive fluid administration increases postoperative complications, worsens pulmonary and cardiac function as well as the healing of surgical wounds. Intraoperative individualised goal-directed fluid therapy (GDT) and zero-balance therapy (weight adjusted) has shown to reduce postoperative complications in elective surgery, but studies in urgent gastrointestinal surgery are sparse. The aim of the trial is to test whether zero-balance GDT reduces postoperative mortality and major complications following urgent surgery for obstructive bowel disease or perforation of the gastrointestinal tract compared with a protocolled standard of care.Methods/analysisThis study is a multicentre, randomised controlled trial with planned inclusion of 310 patients. The randomisation procedure is stratified by hospital and by obstructive bowel disease and perforation of the gastrointestinal tract. Patients are allocated into either 'the standard group' or 'the zero-balance GDT group'. The latter receive intraoperative GDT (guided by a stroke volume algorithm) and postoperative zero-balance fluid therapy based on body weight and fluid charts. The protocolled treatment continues until free oral intake or the seventh postoperative day.The primary composite outcome is death, unplanned reoperations, life-threatening thromboembolic and bleeding complications, a need for mechanical ventilation or dialysis. Secondary outcomes are additional complications, length of hospital stay, length of stay in the intensive care unit, length of mechanical ventilation, readmissions and time to death. Follow-up is 90 days.We plan intention-to-treat analysis of the primary outcome.Ethics and disseminationThe Danish Scientific Ethics Committee approved the GAS-ART trial before patient enrolment (J: SJ-436). Enrolment of patients began in August 2015 and is proceeding. We expect to publish the GAS-ART results in Summer 2019.Trial registration numberEudraCT 2015-000563-14.

Dataset Information

Goal-directed perfusion to reduce acute kidney injury after paediatric cardiac surgery (GDP-AKIp): study protocol for a prospective randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Goal-directed perfusion to reduce acute kidney injury after paediatric cardiac surgery (GDP-AKIp): study protocol for a prospective randomised controlled trial.

Similar Datasets

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