Key result
Intra-operative administration of 6% hydroxyethyl starch 130/0.4 produced similar observed effects on postoperative kidney function compared with 5% human albumin, but greater than expected variability precluded the conclusion of non-inferiority (ratio of geometric means 0.91, p=0.15).
Why the study?
It remained unclear whether third-generation hydroxyethyl starch solutions provoke kidney injury or haemostatic abnormalities in patients undergoing cardiac surgery.
Does intra-operative 6% hydroxyethyl starch 130/0.4 worsen postoperative kidney function or haemostasis in patients undergoing elective aortic valve replacement compared with 5% human albumin?
RCT (n=141)
Triple-blind (participant, investigator, outcomes assessor)
Randomly assigned (1:1) without stratification in random-sized blocks of two to six
No
Does intra-operative 6% hydroxyethyl starch 130/0.4 worsen postoperative kidney function or haemostasis in patients undergoing elective aortic valve replacement compared with 5% human albumin?
Effect estimate: Ratio of geometric means 0.91 (95% CI 0.57-1.44)
Absolute Event Rate: 5% vs 5%
p-value: p=0.15 for noninferiority
Intra-operative use of 6% hydroxyethyl starch 130/0.4 during cardiac surgery produced similar observed effects on kidney function and coagulation compared to 5% albumin, though high variability precluded formal non-inferiority.
Not noninferior for postoperative kidney function after aortic valve replacement; variability leaves equivalence uncertain versus albumin.
Summary 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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Duncan et al. (2020) conducted an RCT in Elective cardiac surgery (aortic valve replacement) (n=141). 6% hydroxyethyl starch 130/0.4 vs. 5% human albumin was evaluated on Postoperative urinary neutrophil gelatinase-associated lipocalin (NGAL) concentrations (Ratio of geometric means 0.91, 95% CI 0.57-1.44, p=0.15 for noninferiority). Intra-operative administration of 6% hydroxyethyl starch 130/0.4 produced similar observed effects on postoperative kidney function compared with 5% human albumin, but greater than expected variability precluded the conclusion of non-inferiority (ratio of geometric means 0.91, p=0.15).