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
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:
98 patients
considered at risk of developing postoperative AKI 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 5 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% vs. 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.[ClinicalTrials.gov
(www.clinicaltrial.gov), No. NCT01758861].