Erythropoietin (EPO) to Protect Renal Function After Cardiac Surgery

NCT ID: NCT01423955

Last Updated: 2013-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2013-04-30

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.

Conditions

Kidney Failure; Renal Failure

Keywords

Erythropoietin; Erythropoetin; Cardiac surgery; Ischemia; Reperfusion; Renal function; Cystatin C; Creatinine; Safety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Erythropoietin

• 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.

Group Type: EXPERIMENTAL

Erythropoietin zeta

Intervention Type: DRUG

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.

Interventions

Erythropoietin zeta

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Active substance: Erythropoietin zeta; Drug brand name: Retacrit®; Manufacturer and Provider: Hospira; ATC-code: B03XA01

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henrik Bjursten, M.D. Ph.D

Role: PRINCIPAL_INVESTIGATOR

Region Skane

Locations

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

Lund, , Sweden

Countries

Sweden

Other Identifiers

2011-001673-70

Identifier Type: -

Identifier Source: org_study_id