Cardioprotective Effects of Endogenous Erythropoietin in Patients Undergoing Coronary Artery Bypass Surgery

Not Applicable

Completed

• Conditions: Cardiac Surgery
• Interventions: Procedure: acute normovolemic hemodilution

• Registration Number: NCT00854217
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

Several studies have highlighted the cardioprotective effects of acute normovolemic hemodilution during cardiac surgery. The aim of our study is to show that an increase in endogenous erythropoietin (EPO) might explain the cardioprotective effects of acute normovolemic hemodilution against ischemia-reperfusion phenomena.

Detailed Description

The major physiologic function of EPO is thought to be the induction of erythropoiesis. However, a growing body of evidence indicates that EPO has tissue-protective effects and prevents tissue damage during ischemia. In an ex vivo proof-of-concept, protective effects of EPO have been shown in human myocardium.

Several studies have demonstrated that acute normovolemic hemodilution before aortic cross clamping decreases perioperative myocardial damage. We hypothesized that the onset of acute anemia increases the endogenous EPO concentration, which explains the cardioprotective effects of acute normovolemic hemodilution.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-02
• Study First Submitted QC: 2009-03-02
• Study First Posted: 2009-03-03
• Primary Completion: 2010-03
• Study Completion: 2010-12
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-02
• Last Update Posted: 2011-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• patients between 18 and 80 years old undergoing CABG with or without cardiopulmonary bypass

Exclusion Criteria

• emergencies
• redo operations
• combined surgery
• men with Hb< 120g/dL and women with Hb< 110g/ dL
• patients with preoperative creatinine> 2.2 mg/dL
• poor ventricular function (EF < 50%)
• subjects with a pulmonary disease, hepatic disease
• subjects with carotid stenosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
placebo, hemodilution	acute normovolemic hemodilution	-

Primary Outcome Measures

Name	Time	Method
Decrease in Troponin -I values	4 h

Trial Locations

Locations (1)

Cliniques Universitaires saint Luc; 🇧🇪 Brussels, Belgium