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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00337805
• Other study ID #: BMA-04-016
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 14, 2006
• Last updated: September 17, 2009
• Start date: September 2004
• Est. completion date: April 2008

Study information

• Verified date: September 2009
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Other:
• Pentaspan
When fluids are indicated either pentaspan or saline are given in a double blind randomized assignment

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Center	Bristol-Myers Squibb

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of catecholamines at 8:00 the morning after surgery		first post operative day	No
Secondary	Total use of catecholamines		Time in ICU	No
Secondary	Time in the ICU		Time in ICU	No
Secondary	Post-operative complications		Hospital stay or 28 days	Yes
Secondary	Bleeding		Hospital stay or 28 days	Yes
Secondary	Renal failure		Hospital stay or 28 days	Yes