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The comparison of albumin and 6% hydroxyethyl starches (130/0.4) in cardiac surgery: a meta-analysis of randomized controlled clinical trials.

ABSTRACT:

Background

Fluid administration is a key tool in the maintenance of normovolemia in patients with cardiac surgery. The trials that evaluated the safety of 6% hydroxyethyl starch (HES) 130/0.4 in cardiac surgical patients were inconsistent. It is necessary to compare the efficacy and safety of albumin and 6% HES (130/0.4).

Method

We searched for the randomized controlled clinical trials that compared human albumin with 6% HES (130/0.4) in cardiac surgery in PubMed, Cochrane, and Embase.

Results

Ten studies involved a total of 1567 patients were included in our meta-analysis. For the efficiency, there was no difference in total volume of infusion between compared groups [P = 0.64, Fixed Effect Model (FEM): standardized mean difference (SMD) = 0.04, 95% confidence interval (CI) (- 0.12, 0.20)]. As for safety, the albumin show more risk than hydroxyethyl starch 130/0.4 in blood loss [P = 0.02, FEM: SMD: 0.22, 95% CI (0.03, 0.41)]. There was no difference in the frequency of transfusions (P = 0.20, RR = 1.11; 95% CI (0.95, 1.27)) between the two groups. No difference was observed for the days in intensive care unit [P = 0.05, FEM: SMD = - 0.18, 95% CI (- 0.36, 0.00)], and the days in hospital [P = 0.32, FEM: SMD = - 0.11, 95% CI (- 0.32, 0.10)]. Furthermore, both the incidence of AKI, RRT, and mortality were comparable in the two groups.

Conclusion

This study provided evidence that the 6% HES (130/0.4) might be the substitute for HA, which reduced the economic burden for patients with cardiac surgery. However, the effect of 6% HES (130/0.4) and HA on AKI still needs to be further studied.

SUBMITTER: Wei L

PROVIDER: S-EPMC8436511 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThe safety of perioperative intravenous hydroxyethyl starch (HES) products, specifically HES 130/0.4, continues to be the source of much debate. The aim of this meta-analysis was to update the existing evidence and gain further insight into the clinical effects of HES 130/0.4 on postoperative outcomes for volume replacement therapy in surgical patients.MethodsMEDLINE, EMBASE, and Cochrane Library databases were searched from inception to March 2020 for relevant randomized controlled trials (RCTs) on perioperative use of HES 130/0.4 in adult surgical patients. The primary outcome was postoperative mortality and secondary outcomes were the incidence of acute kidney injury (AKI) and requirement for renal replacement therapy (RRT). The analysis was performed using the random-effects method and the risk ratio (RR) with a 95% confidence interval (CI). We performed the risk-of-bias assessment of eligible studies and assessed the overall quality of evidence for each outcome.ResultsTwenty-five RCTs with 4111 participants were finally included. There were no statistical differences between HES 130/0.4 and other fluids in mortality at 30 days (RR 1.28, 95% CI 0.88 to 1.86, p = 0.20), the incidence of AKI (RR 1.23, 95% CI 0.99 to 1.53, p = 0.07), or requirement for RRT (RR 0.75, 95% CI 0.37 to 1.53, p = 0.43). Overall, there was a moderate certainty of evidence for all the outcomes. There was no subgroup difference related to the type of surgery (p = 0.17) in the incidence of AKI. As for the type of comparator fluids, however, there was a trend that was not statistically significant (p = 0.06) towards the increased incidence of AKI in the HES 130/0.4 group (RR 1.22, 95% CI 0.97 to 1.54) compared with the crystalloid group (RR 1.21, 95% CI 0.27 to 3.91). Subgroup analyses according to the type of surgery demonstrated consistent findings.ConclusionsThis systematic review and meta-analysis suggests that the use of HES 130/0.4 for volume replacement therapy compared with other fluids resulted in no significant difference in postoperative mortality or kidney dysfunction among surgical patients. Given the absent evidence of confirmed benefit and the potential trend of increased kidney injury, we cannot recommend the routine clinical use of HES 130/0.4 for volume replacement therapy in surgical patients from the perspective of benefit/risk profile. However, the results need to be interpreted with caution due to the limited sample size, and further well-powered RCTs are warranted.Trial registrationPROSPERO registry reference: CRD42020173058.

Project description:There are limited data on the efficacy of early fluid resuscitation with third-generation hydroxyethyl starch (HES 130) in burn injury. Adverse effects of HES on survival and organ function have been reported.In this randomized, controlled, double-blind trial, 48 patients with severe burn injury were assigned to receive either lactated Ringer's solution plus 6% HES 130/0.4 in a ratio of 2:1 or lactated Ringer's solution with no colloid supplement for the first 72 hours. Primary outcome parameter was the group difference of administered total fluid from intensive care unit (ICU) admission up to day 3. Secondary outcomes included kidney and lung injury and failure, length of stay, and mortality.Three-day totals of administered resuscitation fluid (medians) were 21,190 mL in the lactated Ringer's group and 19,535 mL in the HES group (HES: -1,213 mL; P?=?0.39). Creatinine levels from day 1 to 3 (HES: +0.4 ?mol/L; 95% confidence interval (CI) -18.7 to 19.5; P?=?0.97) and urinary outputs from day 1 to 3 (HES: -58 mL; 95% CI -400 to 283; P?=?0.90) were not different. Six patients in each group developed acute respiratory distress syndrome (ARDS) (risk ratio 0.96; 95% CI 0.35 to 2.64; P?=?0.95). Length of ICU stay (HES vs. lactated Ringer's: 28 vs. 24 days; P?=?0.80) and length of hospital stay (31 vs. 29 days; P?=?0.57) were similar. Twenty-eight-day mortality was 4 patients in each group (risk ratio 0.96; 95% CI 0.27 to 4.45; P?=?0.95), and in-hospital mortality was 8 in the HES group vs. 5 patients in the lactated Ringer's group (hazard ratio 1.86; 95% CI 0.56 to 6.19; P?=?0.31).There was no evidence that early fluid resuscitation with balanced HES 130/0.4 (6%) in addition to lactated Ringer's solution would lead to a volume-sparing effect in severe burn injury. Together with the findings that early renal function, incidence of ARDS, length of stay, and mortality were not negatively influenced by HES in this setting, balanced HES 130/0.4 (6%) plus lactated Ringer's solution could not be considered superior to lactated Ringer's solution alone.ClinicalTrials.gov NCT01012648.