No Differences in Renal Function between Balanced 6% Hydroxyethyl Starch (130/0.4) and 5% Albumin for Volume Replacement Therapy in Patients Undergoing Cystectomy

Abstract

Background The use of artificial colloids has declined in critical care, whereas they are still used in perioperative medicine. Little is known about the nephrotoxic potential in noncritically ill patients during routine surgery. The objective of this trial was to evaluate the influences of albumin 5% and balanced hydroxyethyl starch 6% (130/0.4) on renal function and kidney injury. Methods One hundred urologic patients undergoing elective cystectomy were randomly assigned for this prospective, single-blinded, controlled study with two parallel groups to receive either albumin 5% or balanced hydroxyethyl starch 6% (130/0.4) as the only perioperative colloid. The primary endpoint was the ratio of serum cystatin C between the last visit at day 90 and the first preoperative visit. Secondary endpoints were estimated glomerular filtration rate and serum neutrophil gelatinase-associated lipocalin until the third postoperative day and risk, injury, failure, loss, and end-stage renal disease criteria at postoperative days 3 and 90. Results The median cystatin C ratio was 1.11 (interquartile range, 1.01 to 1.23) in the albumin and 1.08 (interquartile range, 1.00 to 1.20) in the hydroxyethyl starch group (median difference = 0.03; 95% CI, –0.09 to 0.08; P = 0.165). Also, there were no significant differences concerning serum cystatin C concentrations; estimated glomerular filtration rate; risk, injury, failure, loss, and end-stage renal disease criteria; and neutrophil gelatinase-associated lipocalin. Infusion requirements, transfusion rates, and perioperative hemodynamics were similar in both groups. Conclusions With respect to renal function and kidney injury, this study indicates that albumin 5% and balanced hydroxyethyl starch 6% have comparable safety profiles in noncritically ill patients undergoing major surgery.

Postoperative renal morbidity and mortality after volume replacement with hydroxyethyl starch 130/0.4 or albumin during surgery: a propensity score-matched study

“…Also, in two randomized controlled trials [19,33] and a retrospective cohort study [20] of children undergoing cardiac surgery, HES 130/0.4 was associated with less fluid balance and lower amounts of transfusion than albumin and was not negatively associated with postoperative outcomes, including renal morbidity. A randomized controlled trial in patients undergoing cystectomy found that perioperative changes in cystatin C as a component of glomerular filtration rate and neutrophil gelatinase-associated lipocalin as a marker of tubular injury did not differ between balanced HES 130/0.4 (Volulyte ® ; Fresenius Kabi GmbH, Germany) and albumin [21]. All of the literature above support the use of 6% HES 130/0.4 as an effective and safe alternative to albumin during surgery.…”

“…The sample size was the total number of eligible patients seen during the 3-year study period; no a priori sample size calculation was performed because the study was retrospective. In recent literature, the postoperative incidence of AKI [16,21]. We assumed, therefore, that a 10% difference in the primary outcome would be clinically relevant and calculated that 540 matched patients (270 pairs) were needed to have 80% power to detect a 10% absolute difference in the incidence of AKI between the HES and the albumin group at the 0.05 level.…”

“…Additionally, a study of patients undergoing cardiac surgery using a propensity score-matching method showed that albumin was dose-dependently associated with increasing risk of acute kidney injury (AKI) [16]. In studies of children undergoing cardiac surgery [19,20] and in adults undergoing elective cystectomy [21], renal morbidity and safety profiles of HES 130/0.4 did not differ from those of albumin. A study reported that using 6% HES 130/0.4 as an alternative to albumin could potentially reduce the amount of albumin used to treat surgical bleeding by up to 80% [22].…”

Hydroxyethyl starch for perioperative goal-directed fluid therapy in 2020: a narrative review

“…One small single-center, single-blinded randomized trial compared 5% albumin solution to 6% HES 130/0.4 solution used as part of a GDFT protocol in patients undergoing elective cystectomy [73]. There was no significant difference between the two groups with respect to the primary outcome, i.e., kidney function and kidney injury assessed up to postoperative day 90.…”

Intravenous Fluid of Choice in Major Abdominal Surgery: A Systematic Review

“…Demir et al [20] compared HES 130/0.4 (Voluven) to 4% gelatin (Gelofusine) in patients who underwent a liver transplant and reported a nonsignificant incidence of acute kidney injury (AKI) grade I in the gelatin group (2 vs. 5). Two studies [26,38] compared HES 130/0.4 (Voluven) to 5% human albumin and reported no differences in the renal dysfunction at neither immediate postoperation [36,38] nor 3-month postoperation [38] using the cystatin C/Cr ratio. Critical Care Research and Practice [28,37,39], Plasmalyte [29,54], and acetate buffer crystal [40]) in kidney transplant patients.…”