Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery
Phase 2
Completed
- Conditions
- Cardiac Surgery
- Registration Number
- NCT00337805
- Lead Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Brief Summary
This is a randomized double blind trial of the use of the use of colloids vs crystalloid solutions for resuscitation of patients after cardiac surgery. Patients are managed with an algorithm driven protocol that is based on the flow response to fluid challenges. The hypothesis is that the use of a colloid solution will result in less use of catecholamines at 8:00 the morning following surgery. Secondary end-points include total use of catecholamines, time in the ICU, return to the ICU, and safety issues including bleeding and renal function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
Inclusion Criteria
- status post cardiac surgery
- pulmonary artery occlusion catheter in place
- informed consent
- morning case (must be out of OR by 2:00 PM
Exclusion Criteria
- excessive bleeding (> 200 cc/hr)
- intraaortic balloon pump
- refusal by treating team
- emergency cases
- patients with known adverse reactions to starch solutions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Use of catecholamines at 8:00 the morning after surgery first post operative day
- Secondary Outcome Measures
Name Time Method Total use of catecholamines Time in ICU Time in the ICU Time in ICU Post-operative complications Hospital stay or 28 days Bleeding Hospital stay or 28 days Renal failure Hospital stay or 28 days
Trial Locations
- Locations (1)
Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada
Royal Victoria Hospital🇨🇦Montreal, Quebec, Canada