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

Larissa University Hospital

Status: Completed

Conditions: Coronary Artery Disease; Coronary Artery Bypass; Erythrocyte Transfusion

Treatments: Procedure: Free fluid infusion; Procedure: Fluid Restriction Policy

Study type: Interventional

Funder types: Other

Identifiers

NCT00600704

LUH 1975 AK

POL 1969 TT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 192 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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192 participants in 2 patient groups

RESTRICTED FLUIDS

Active Comparator group

Description:

Infusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary Bypass

Treatment:

Procedure: Fluid Restriction Policy

FREE FLUIDS

Active Comparator group

Description:

Free fluid infusion unless Hb\< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass

Treatment:

Procedure: Free fluid infusion