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

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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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Bypass Coronary Disease Erythrocyte Transfusion Exsanguination Heart Diseases Hemorrhage Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Larissa University Hospital

Larissa, Thesalia, 41110, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluid Restriction Policy

Procedure

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

Free fluid infusion

Procedure

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

Primary outcomes

Mean Number of Packed Red Cells Units Transfused During Hospital Stay

Time frame: 20 months

Sponsors and collaborators

Lead sponsor

Larissa University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2011
First posted: Jan 25, 2008
Registry last updated: Jun 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed