Erythropoietin (EPO) to Protect Renal Function After Cardiac Surgery

Phase 2

Completed

• Conditions: Renal Failure; Kidney Failure
• Interventions: Drug: Erythropoietin zeta; Drug: Placebo

• Registration Number: NCT01423955
• Lead Sponsor: Region Skane

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2011-08-24
• Study First Submitted QC: 2011-08-25
• Study First Posted: 2011-08-26
• Study Start: 2011-10
• Primary Completion: 2013-01
• Study Completion: 2013-04
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-24
• Last Update Posted: 2013-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erythropoietin	Erythropoietin zeta	• Active substance: Erythropoietin zeta with the ATC-code: B03XA01. The drug is a Clear colorless solution for injection. The active substance will be diluted with NaCl 9mg/ml to a to a concentration of 2000 U/ml. A dose of 400U/kg will be prepared and marked before the operation. The drug will be administrated after the anesthesia induction and before the start of surgery.
Placebo	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Change in plasma cystatin C measured on day 3 postoperatively.	3 days postoperatively

Trial Locations

Locations (1)

Dept Thoracic Surgery, Anestesia and Intensive Care, SUS-Lund; 🇸🇪 Lund, Sweden