Erythropoietin (EPO) to Protect Renal Function After Cardiac Surgery

Region Skane75 enrolled

Overview

The purpose of this study is to evaluate the potential of erythropoietin in reducing risk and degree of acute kidney injury after cardiac surgery.

Acute kidney injury is a common complication after cardiac surgery and is associated with decreased long-term survival. Several experimental and animal studies have showed cytoprotective, preconditioning and anti-apoptotic effects of high dose erythropoietin. Clinical studies in human have also suggested that high dose erythropoietin has preconditioning effects against injury after ischemia and reperfusion on different organs in human, such as brain, heart, liver, and kidneys. Administration of Epo in high doses in conjunction with cardiac surgery has shown to be safe with no direct side-effects. The investigators therefore hypothesize that a preconditioning effect of erythropoietin before cardiac surgery can reduce the level of renal dysfunction after surgery in a group with preoperative renal impairment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Kidney Failure Renal Failure

Interventions

Erythropoietin zetaDRUG

The active drug will be given only once after the anesthesia induction and before the start of surgery. The active drug will be diluted to 2000U/kg and given as a single dose of 400U/kg. The dose will be prepared prior to surgery by a independent nurse.

PlaceboDRUG

Placebo arm will receive NaCl 9mg/ml with a dose of 0.2 ml/kg. The placebo dose will be prepared prior to the surgery by a independent nurse. The calculated volume will match the volume of the active durg.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient is scheduled for non-emergent CABG surgery. * CyC eGFR or MDRD eGFR \< 60 ml/min. * The patient has given his/her written consent to participate Exclusion Criteria: * The patient has an uncontrolled hypertension. * Hypersensitivity to the active drug. * The patient is pregnant or is a fertile woman (\<50 years). * The patient has been treated with Erythropoietin within 4 weeks prior to the surgery. * Preoperative CyC eGFR or MDRD eGFR is \< 15, or the patient is treated with dialysis. * The patient has a known malignancy. * The patient is planned for Off-pump CABG surgery. * The patient is included in other ongoing clinical trial. Yes / No * Clinically judgment by the investigator that the patient should not participate in the study.

Locations (1)

Dept Thoracic Surgery, Anestesia and Intensive Care, SUS-Lund

Lund, Sweden

Outcomes

Primary Outcomes

Change in plasma cystatin C measured on day 3 postoperatively.

Time frame: 3 days postoperatively

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.