NCT01423955

Erythropoietin (EPO) to Protect Renal Function After Cardiac Surgery

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-01-01
• Completion: 2013-04-01
• First posted: 2011-08-26
• Last updated: 2013-10-25

Locations

1 site across 1 country: Sweden