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

This study is currently recruiting participants.

Verified by McGill University Health Center, June 2006

Sponsors and Collaborators:	McGill University Health Center Bristol-Myers Squibb
Information provided by:	McGill University Health Center
ClinicalTrials.gov Identifier:	NCT00337805

Purpose

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.

Condition	Intervention	Phase
Cardiac Surgery	Drug: Pentaspan	Phase II Phase III

MedlinePlus related topics: Heart Surgery

Drug Information available for: Hetastarch

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Trial of Synthetic vs Normal Saline for the Flow-Based Algorithmic Hemodynamic Resuscitation of Patients Post-Cardiac Surgery

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:

Use of catecholamines at 8:00 the morning after surgery

Secondary Outcome Measures:

Total use of catecholamines
Time in the ICU
Post-operative complications
Bleeding
Renal failure

Estimated Enrollment:	240
Study Start Date:	September 2004
Estimated Study Completion Date:	April 2007

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337805

Contacts

Contact: Lena Havell-Charlebois, RN

514-934-1934 ext 36736

lena.havell@muhc.mcgill.ca

Locations

Canada, Quebec
Royal Victoria Hospital	Recruiting
Montreal, Quebec, Canada, H3A 1A1
Principal Investigator: sheldon magder, md

Sponsors and Collaborators

McGill University Health Center

Bristol-Myers Squibb

Investigators

Principal Investigator:

sheldon magder, md

McGill University

More Information

Study ID Numbers:	BMA-04-016
Study First Received:	June 14, 2006
Last Updated:	April 11, 2007
ClinicalTrials.gov Identifier:	NCT00337805
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:

colloid
crystalloid
hemodynamics
flow-directed
resuscitation

Study placed in the following topic categories:

Hetastarch

Additional relevant MeSH terms:

Therapeutic Uses
Hematologic Agents
Blood Substitutes
Plasma Substitutes
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009