Effect of erythropoietin on the incidence of acute kidney injury following complex valvular heart surgery: a double blind, randomized clinical trial of efficacy and safety

Ji-Ho Kim, Jae-Kwang Shim, Jong-Wook Song, Young Song, Hye-Bin Kim, Young-Lan Kwak, Ji-Ho Kim, Jae-Kwang Shim, Jong-Wook Song, Young Song, Hye-Bin Kim, Young-Lan Kwak

Abstract

Introduction: Recombinant human erythropoietin (EPO) is known to provide organ protection against ischemia-reperfusion injury through its pleiotropic properties. The aim of this single-site, randomized, case-controlled, and double-blind study was to investigate the effect of pre-emptive EPO administration on the incidence of postoperative acute kidney injury (AKI) in patients with risk factors for AKI undergoing complex valvular heart surgery.

Methods: We studied ninety-eight patients with preoperative risk factors for AKI. The patients were randomly allocated to either the EPO group (n = 49) or the control group (n = 49). The EPO group received 300 IU/kg of EPO intravenously after anesthetic induction. The control group received an equivalent volume of normal saline. AKI was defined as an increase in serum creatinine >0.3 mg/dl or >50% from baseline. Biomarkers of renal injury were serially measured until five days postoperatively.

Results: Patient characteristics and operative data, including the duration of cardiopulmonary bypass, were similar between the two groups. Incidence of postoperative AKI (32.7% versus 34.7%, P = 0.831) and biomarkers of renal injury including cystatin C and neutrophil gelatinase-associated lipocalin showed no significant differences between the groups. The postoperative increase in interleukin-6 and myeloperoxidase was similar between the groups. None of the patients developed adverse complications related to EPO administration, including thromboembolic events, throughout the study period.

Conclusions: Intravenous administration of 300 IU/kg of EPO did not provide renal protection in patients who are at increased risk of developing AKI after undergoing complex valvular heart surgery.

Trial registration: Clinical Trial.gov, NCT01758861.

Figures

Figure 1
Figure 1
Diagram representing study cohort allocation.
Figure 2
Figure 2
Changes of log transformed serum interlukin-6 (A) and myeloperoxidase (B) over time in the control group and EPO group. Values are mean ± SD. EPO, erythropoietin; Log IL6, logarithm of interlukin 6; Log MPO, logarithm of myeloperoxidase. *P <0.05, compared with baseline (type I error was corrected by Bonferroni method, all time points were statistically significantly different from baseline).

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