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

Phase 2

Completed

• Conditions: Cardiac Surgery
• Interventions: Other: Pentaspan

• 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

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2006-06-14
• Study First Submitted QC: 2006-06-14
• Study First Posted: 2006-06-16
• Primary Completion: 2007-12
• Study Completion: 2008-04
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-17
• Last Update Posted: 2009-09-18

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

Arm && Interventions

Group	Intervention	Description
1 colloid	Pentaspan	Boluses of fluids are a pentastarch (up to 1000 ml)
2. Crytalloid	Pentaspan	Boluses are given as normal saline

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