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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:Whether third-generation hydroxyethyl starch solutions provoke kidney injury or haemostatic abnormalities in patients having cardiac surgery remains unclear. We tested the hypotheses that intra-operative administration of a third-generation starch does not worsen postoperative kidney function or haemostasis in cardiac surgical patients compared with human albumin 5%. This triple-blind, non-inferiority, clinical trial randomly allocated patients aged 40-85 who underwent elective aortic valve replacement, with or without coronary artery bypass grafting, to plasma volume replacement with 6% starch 130/0.4 vs. 5% human albumin. Our primary outcome was postoperative urinary neutrophil gelatinase-associated lipocalin concentrations, a sensitive and early marker of postoperative kidney injury. Secondarily, we evaluated urinary interleukin-18; acute kidney injury using creatinine RIFLE criteria, coagulation measures, platelet count and function. Non-inferiority (delta 15%) was assessed with correction for multiple comparisons. We enrolled 141 patients (69 starch, 72 albumin) as planned. Results of the primary analysis demonstrated that postoperative urine neutrophil gelatinase-associated lipocalin (median (IQR [range])) was slightly lower with hydroxyethyl starch (5 (1-68 [0-996]) ng.ml-1 ) vs. albumin (5 (2-74 [0-1604]) ng.ml-1 ), although not non-inferior [ratio of geometric means (95%CI) 0.91 (0.57, 1.44); p = 0.15] due to higher than expected variability. Urine interleukin-18 concentrations were reduced, but interleukin-18 and kidney injury were again not non-inferior. Of 11 individual coagulation measures, platelet count and function, nine were non-inferior to albumin. Two remaining measures, thromboelastographic R value and arachidonic acid-induced platelet aggregation, were clinically similar but with wide confidence intervals. Starch administration during cardiac surgery produced similar observed effects on postoperative kidney function, coagulation, platelet count and platelet function compared with albumin, though greater than expected variability and wide confidence intervals precluded the conclusion of non-inferiority. Long-term mortality and kidney function appeared similar between starch and albumin.

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