Trials / Completed
CompletedNCT00600704
Impact of Fluid Restriction Policy in Reducing the Use of Red Cells in Cardiac Surgery
Impact of Fluid Restriction Policy Added to Intra-Operative Cell Salvage in Reducing the Use of Red Cells in Cardiac Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 192 (actual)
- Sponsor
- Larissa University Hospital · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Fluid Restriction Policy | Infusion of Hes 130/0.4 up to 500 ml until the beginning of Cardiopulmonary bypass |
| PROCEDURE | Free fluid infusion | Free fluid infusion unless Hb\< 6g/dl(allogenic blood use), until the beginning of Cardiopulmonary bypass |
Timeline
- Start date
- 2007-11-01
- Primary completion
- 2008-11-01
- Completion
- 2011-03-01
- First posted
- 2008-01-25
- Last updated
- 2011-06-07
- Results posted
- 2011-06-07
Locations
1 site across 1 country: Greece
Source: ClinicalTrials.gov record NCT00600704. Inclusion in this directory is not an endorsement.