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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2011-03-31

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.

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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.

Conditions

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Coronary Artery Disease Coronary Artery Bypass Erythrocyte Transfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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RESTRICTED FLUIDS

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

Group Type ACTIVE_COMPARATOR

Fluid Restriction Policy

Intervention Type PROCEDURE

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

FREE FLUIDS

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

Group Type ACTIVE_COMPARATOR

Free fluid infusion

Intervention Type PROCEDURE

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

Interventions

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Fluid Restriction Policy

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

Intervention Type PROCEDURE

Free fluid infusion

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

Intervention Type PROCEDURE

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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LARISSA UNIVERSITY HOSPITAL/DPT OF ANESTHESIOLOGY

Principal Investigators

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ATHINA KLEITSAKI, Dr

Role: PRINCIPAL_INVESTIGATOR

Larissa University Hospital