Erythropoietin (EPO) to Protect Renal Function After Cardiac Surgery

Renal Failure Clinical Trial

— EPRICS  

Official title:

EPO to Protect Renal Function After Cardiac Surgery. A Phase II Double Blind Randomized Controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01423955
• Other study ID #: 2011-001673-70
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2011
• Last updated: October 24, 2013
• Start date: October 2011
• Est. completion date: April 2013

Study information

• Verified date: October 2013
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure
• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Dept Thoracic Surgery, Anestesia and Intensive Care, SUS-Lund	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in plasma cystatin C measured on day 3 postoperatively.		3 days postoperatively	Yes