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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: Larissa University Hospital

Current Primary Outcome: Mean Number of Packed Red Cells Units Transfused During Hospital Stay [ Time Frame: 20 months ]

Original Primary Outcome: Evidence of reduction of use of allogenic blood by fluid restriction policy [ Time Frame: one year ]

Current Secondary Outcome:

Original Secondary Outcome: Total blood loss [ Time Frame: 3 years ]

Information By: Larissa University Hospital

Dates:
Date Received: January 14, 2008
Date Started: November 2007
Date Completion:
Last Updated: May 9, 2011
Last Verified: March 2011