Nine RCTs with 3,456 patients were included in the review. Four RCTs were considered at low risk of bias, the other five were at high risk of bias in at least one domain.
Mortality: There was no statistically significant difference between groups treated with hydroxyethyl starch 130/0.38-0.45 and comparison groups (RR 1.04, 95% CI 0.89 to 1.22; Ι²=37%; eight trials). Sensitivity, subgroup and trial sequential analyses did not change the overall result.
Renal replacement therapy at end of follow-up: Only three events (two in the intervention groups, one in the control group) were reported for this outcome (five trials); the data were not pooled.
Other efficacy outcomes: Patients treated with hydroxyethyl starch 130/0.38-0.45 had a statistically significantly higher chance of needing renal replacement therapy at any point during follow-up (RR 1.36, 95% CI 1.08 to 1.72; Ι²=0; five trials) and of having a red blood cell transfusion (RR 1.29, 95% CI 1.13 to 1.48; Ι²=0%; three trials). Other transfusion related outcomes did not differ significantly between the groups but favoured controls. The risk of acute kidney injury was also non-significantly higher in the intervention groups.
Serious adverse events: The risk of a serious adverse event was statistically significantly higher in the intervention groups (RR 1.30, 95% CI 1.02 to 1.67; Ι²=0%; three trials).
Results of trial sequential analyses were also reported for secondary outcomes.