A Phase 2/3 interventional study of Pentaspan in Cardiac Surgery, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2009-09-18.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 2/3, Interventional, and Treatment
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.
McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Boluses of fluids are a pentastarch (up to 1000 ml)
Other: Pentaspan
Boluses are given as normal saline
Other: Pentaspan
When fluids are indicated either pentaspan or saline are given in a double blind randomized assignment
Use of catecholamines at 8:00 the morning after surgery
Time frame: first post operative day
Total use of catecholamines
Time frame: Time in ICU
Time in the ICU
Time frame: Time in ICU
Post-operative complications
Time frame: Hospital stay or 28 days
Bleeding
Time frame: Hospital stay or 28 days
Renal failure
Time frame: Hospital stay or 28 days
This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.
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McGill University Health Centre/Research Institute of the McGill University Health Centre