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

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Coronary Artery Bypass; Erythrocyte Transfusion
• Interventions: Procedure: Fluid Restriction Policy; Procedure: Free fluid infusion

• Registration Number: NCT00600704
• Lead Sponsor: Larissa University Hospital

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 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 Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-01-14
• Study First Submitted QC: 2008-01-24
• Study First Posted: 2008-01-25
• Primary Completion: 2008-11
• Status Verified: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2011-03-04
• Results First Submitted QC: 2011-05-09
• Last Update Submitted: 2011-05-09
• Results First Posted: 2011-06-07
• Last Update Posted: 2011-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

• Ejection fraction (EF) of left ventricle (LV) > 35%
• Preoperative serum Creatinine < 150 μmol/l
• Preoperative Haemoglobin > 10/dl
• Peripheral anastomosis scheduled =< 3

Exclusion Criteria

• redo bypass-emergency operations
• prior coronal stenting
• active congestive heart failure
• documented Myocardial Infraction within the previous 6 weeks
• NYHA class > 3
• Carotid stenosis > 50%
• CVA
• INR > 1.5
• chronic obstructive pulmonary disease (COPD)
• Steroid therapy-chronic inflammatory process
• Use of aprotinin or tranexamic acid

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RESTRICTED FLUIDS	Fluid Restriction Policy	Infusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary Bypass
FREE FLUIDS	Free fluid infusion	Free fluid infusion unless Hb\< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass

Primary Outcome Measures

Name	Time	Method
Mean Number of Packed Red Cells Units Transfused During Hospital Stay	20 months

Trial Locations

Locations (1)

Larissa University Hospital; 🇬🇷 Larissa, Thesalia, Greece