N/A
N=192
Impact of Fluid Restriction Policy in Reducing the Use of Red Cells in Cardiac Surgery
Coronary Artery Disease · Coronary Artery Bypass · Erythrocyte Transfusion
Bottom Line
View on ClinicalTrials.gov: NCT00600704 ↗Enrolled (actual)
192
Serious AEs
19.8%
Results posted
Jun 2011
Primary outcome: Primary: Mean Number of Packed Red Cells Units Transfused During Hospital Stay — 1.13; 1.91 packed red cells units — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fluid Restriction Policy (Procedure); Free fluid infusion (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Larissa University Hospital
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of Packed Red Cells Units Transfused During Hospital Stay |
1.13; 1.91 | <0.05 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Ejection fraction (EF) of left ventricle (LV) > 35%
- Preoperative serum Creatinine 10/dl
- Peripheral anastomosis scheduled = 3
- Carotid stenosis > 50%
- CVA
- INR > 1.5
- chronic obstructive pulmonary disease (COPD)
- Steroid therapy-chronic inflammatory process
- Use of aprotinin or tranexamic acid
Data sourced from ClinicalTrials.gov (NCT00600704). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.