Impact of Fluid Restriction Policy in Reducing the Use of Red Cells in Cardiac Surgery

Coronary Artery Disease Clinical Trial

Official title: Impact of Fluid Restriction Policy Added to Intra-Operative Cell Salvage in Reducing the Use of Red Cells in Cardiac Surgery

Status Completed

Clinical Trial Summary

The investigators' hypothesis is that restriction of circulating fluids in comparison to a liberal fluid administration policy would lead to a reduction of allogenic red blood cells exposure in patients undergoing cardiopulmonary bypass (CPB) for primary coronary artery bypass graft supported by reinfusion of washed shed blood from thoracic cavities.

Clinical Trial Description

192 patients operated under equal conditions were assigned prospectively and randomly either for a restrictive protocol for intravenous fluid administration (group A, 100 patients) or not (group B, 92 patients). Transfusion guidelines were common for the two groups. The volumes of intravenous fluids, priming, "extra" volume on pump and cardioplegic solution and the volume of urine were recorded. Net erythrocyte volume loss was calculated. The number of the transfused PRC was analyzed as a continuous variable. "Transfusion" was analyzed as a categorical characteristic. Analysis employed Student's two-tailed t-test, t-paired test and chitest. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Coronary Artery Bypass
• Coronary Artery Disease
• Coronary Disease
• Erythrocyte Transfusion
• Myocardial Ischemia

• NCT number: NCT00600704
• Study type: Interventional
• Source: Larissa University Hospital
• Status: Completed
• Phase: N/A
• Start date: November 2007
• Completion date: March 2011