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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease, Coronary Artery Bypass, Erythrocyte Transfusion

Intervention / Treatment
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* Procedure: Fluid Restriction Policy
* Procedure: Free fluid infusion


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RESTRICTED FLUIDS<br>Infusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary Bypass | Procedure: Fluid Restriction Policy<br>* Infusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary bypass<br>|
| Active Comparator: FREE FLUIDS<br>Free fluid infusion unless Hb< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass | Procedure: Free fluid infusion<br>* Free fluid infusion unless Hb< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Packed Red Cells Units Transfused During Hospital Stay |  | 20 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allogenic Blood Use, Total Blood Loss, Reinfusion of Washed Shed Blood