NCT00337805

Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery

A Randomized Trial of Synthetic vs Normal Saline for the Flow-based Algorithmic Hemodynamic Resuscitation of Patients Post-cardiac Surgery

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Surgery

Interventions

Type	Name	Description
OTHER	Pentaspan	When fluids are indicated either pentaspan or saline are given in a double blind randomized assignment

Timeline

• Start date: 2004-09-01
• Primary completion: 2007-12-01
• Completion: 2008-04-01
• First posted: 2006-06-16
• Last updated: 2009-09-18

Locations

1 site across 1 country: Canada