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Erythropoietin (EPO) to Protect Renal Function After Cardiac Surgery

Information source: Region Skane
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Failure; Renal Failure

Intervention: Erythropoietin zeta (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Region Skane

Official(s) and/or principal investigator(s):
Henrik Bjursten, M.D. Ph.D, Principal Investigator, Affiliation: Region Skane

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.

Clinical Details

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

Primary outcome: Change in plasma cystatin C measured on day 3 postoperatively.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Dept Thoracic Surgery, Anestesia and Intensive Care, SUS-Lund, Lund 221 85, Sweden
Additional Information

Starting date: October 2011
Last updated: October 24, 2013

Page last updated: August 20, 2015

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