Sources of Heterogeneity in Trials Reporting Hydroxyethyl Starch 130/0.4 or 0.42 Associated Excess Mortality in Septic Patients

Background:. This meta-analysis was to determine the association of the cumulative dose of 130/0.4 or 0.42 (hydroxyethyl starch [HES] 130/0.4*) or delta daily fluid balance (i.e., daily fluid balance in HES group over or below control group) with the heterogeneity of risk ratio (RR) for mortality in...

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Main Authors: Peng-Lin Ma, Xiao-Xia Peng, Bin Du, Xiao-Lan Hu, Yi-Chun Gong, Yu Wang, Xiu-Ming Xi
Format: Article
Language:English
Published: Wolters Kluwer 2015-09-01
Series:Chinese Medical Journal
Online Access:http://journals.lww.com/10.4103/0366-6999.163387
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author Peng-Lin Ma
Xiao-Xia Peng
Bin Du
Xiao-Lan Hu
Yi-Chun Gong
Yu Wang
Xiu-Ming Xi
author_facet Peng-Lin Ma
Xiao-Xia Peng
Bin Du
Xiao-Lan Hu
Yi-Chun Gong
Yu Wang
Xiu-Ming Xi
author_sort Peng-Lin Ma
collection DOAJ
description Background:. This meta-analysis was to determine the association of the cumulative dose of 130/0.4 or 0.42 (hydroxyethyl starch [HES] 130/0.4*) or delta daily fluid balance (i.e., daily fluid balance in HES group over or below control group) with the heterogeneity of risk ratio (RR) for mortality in randomized control trials (RCTs). Methods:. Three databases (PubMed, EMBASE, Cochrane) were searched to identify prospective RCTs reporting mortality in adult patients with sepsis to compare HES130/0.4* with crystalloids or albumin. Meta-analysis was performed using random effects. Sensitivity and meta-regression analyses were used to examine the heterogeneity sources of RR for mortality. Results:. A total number of 4408 patients from 11 RCTs were included. The pooled RR showed no significant difference for overall mortality in patients with administration of HES130/0.4* compared with treatment of control fluids (RR: 1.02, 95% confidence interval: 0.90-1.17; P = 0.73). Heterogeneity was moderate across recruited trials (I2 = 34%, P = 0.13). But, a significant variation was demonstrated in subgroup with crystalloids as control fluids (I2= 42%, P < 0.1). Sensitivity analysis revealed that trials with high risk of bias did not significantly impact the pooled estimates for mortality. Meta-regression analysis also did not determine a dose-effect relationship of HES130/0.4* with mortality (P = 0.298), but suggested daily delta fluid balance being likely associated with mortality in septic patients receiving HES130/130/0.4* (P = 0.079). Conclusions:. Inappropriate daily positive fluid balance was likely an important source of heterogeneity in these trials reporting HES130/0.4* associated with excess mortality in septic patients.
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spelling doaj.art-f8b155d8c3d442eabdcb73b1dc817eb82023-10-30T03:37:44ZengWolters KluwerChinese Medical Journal0366-69992542-56412015-09-01128172374238210.4103/0366-6999.163387cm9-128-2374Sources of Heterogeneity in Trials Reporting Hydroxyethyl Starch 130/0.4 or 0.42 Associated Excess Mortality in Septic PatientsPeng-Lin Ma0Xiao-Xia Peng1Bin Du2Xiao-Lan Hu3Yi-Chun Gong4Yu Wang5Xiu-Ming Xi61 Department of Critical Care Medicine, 309th Hospital of Chinese People's Liberation Army, Beijing 100091, China2 Centre of Clinical Epidemiology and Evidence-based Medicine, Beijing Children Hospital, Capital Medical University, School of Public Health, Capital Medical University, Beijing 100069, China3 Medical ICU, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing 100730, China2 Centre of Clinical Epidemiology and Evidence-based Medicine, Beijing Children Hospital, Capital Medical University, School of Public Health, Capital Medical University, Beijing 100069, China1 Department of Critical Care Medicine, 309th Hospital of Chinese People's Liberation Army, Beijing 100091, China1 Department of Critical Care Medicine, 309th Hospital of Chinese People's Liberation Army, Beijing 100091, China4 Department of Critical Care Medicine, Beijing Fuxing Hospital, Capital Medical University, Beijing 100038, ChinaBackground:. This meta-analysis was to determine the association of the cumulative dose of 130/0.4 or 0.42 (hydroxyethyl starch [HES] 130/0.4*) or delta daily fluid balance (i.e., daily fluid balance in HES group over or below control group) with the heterogeneity of risk ratio (RR) for mortality in randomized control trials (RCTs). Methods:. Three databases (PubMed, EMBASE, Cochrane) were searched to identify prospective RCTs reporting mortality in adult patients with sepsis to compare HES130/0.4* with crystalloids or albumin. Meta-analysis was performed using random effects. Sensitivity and meta-regression analyses were used to examine the heterogeneity sources of RR for mortality. Results:. A total number of 4408 patients from 11 RCTs were included. The pooled RR showed no significant difference for overall mortality in patients with administration of HES130/0.4* compared with treatment of control fluids (RR: 1.02, 95% confidence interval: 0.90-1.17; P = 0.73). Heterogeneity was moderate across recruited trials (I2 = 34%, P = 0.13). But, a significant variation was demonstrated in subgroup with crystalloids as control fluids (I2= 42%, P < 0.1). Sensitivity analysis revealed that trials with high risk of bias did not significantly impact the pooled estimates for mortality. Meta-regression analysis also did not determine a dose-effect relationship of HES130/0.4* with mortality (P = 0.298), but suggested daily delta fluid balance being likely associated with mortality in septic patients receiving HES130/130/0.4* (P = 0.079). Conclusions:. Inappropriate daily positive fluid balance was likely an important source of heterogeneity in these trials reporting HES130/0.4* associated with excess mortality in septic patients.http://journals.lww.com/10.4103/0366-6999.163387
spellingShingle Peng-Lin Ma
Xiao-Xia Peng
Bin Du
Xiao-Lan Hu
Yi-Chun Gong
Yu Wang
Xiu-Ming Xi
Sources of Heterogeneity in Trials Reporting Hydroxyethyl Starch 130/0.4 or 0.42 Associated Excess Mortality in Septic Patients
Chinese Medical Journal
title Sources of Heterogeneity in Trials Reporting Hydroxyethyl Starch 130/0.4 or 0.42 Associated Excess Mortality in Septic Patients
title_full Sources of Heterogeneity in Trials Reporting Hydroxyethyl Starch 130/0.4 or 0.42 Associated Excess Mortality in Septic Patients
title_fullStr Sources of Heterogeneity in Trials Reporting Hydroxyethyl Starch 130/0.4 or 0.42 Associated Excess Mortality in Septic Patients
title_full_unstemmed Sources of Heterogeneity in Trials Reporting Hydroxyethyl Starch 130/0.4 or 0.42 Associated Excess Mortality in Septic Patients
title_short Sources of Heterogeneity in Trials Reporting Hydroxyethyl Starch 130/0.4 or 0.42 Associated Excess Mortality in Septic Patients
title_sort sources of heterogeneity in trials reporting hydroxyethyl starch 130 0 4 or 0 42 associated excess mortality in septic patients
url http://journals.lww.com/10.4103/0366-6999.163387
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