Cardiac Surgery
Conditions
Keywords
colloid, crystalloid, hemodynamics, flow-directed, resuscitation
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.
Interventions
OTHERPentaspan
When fluids are indicated either pentaspan or saline are given in a double blind randomized assignment
Sponsors
Bristol-Myers Squibb
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Use of catecholamines at 8:00 the morning after surgery | first post operative day |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada
Outcome results
None listed