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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 14, 2006

Last Updated Date

April 11, 2007

Start Date ^†

September 2004

Current Primary Outcome Measures ^†

Use of catecholamines at 8:00 the morning after surgery

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00337805 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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

Study Phase

Phase II, Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^†

Cardiac Surgery

Intervention ^†

Drug: Pentaspan

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

240

Estimated Completion Date

April 2007

Primary Completion Date

Eligibility 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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Contact: Lena Havell-Charlebois, RN

514-934-1934 ext 36736

lena.havell@muhc.mcgill.ca

Location Countries ^†

Canada

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00337805

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

McGill University Health Center

Collaborators ^††

Bristol-Myers Squibb

Investigators ^†

Principal Investigator:

sheldon magder, md

McGill University

Information Provided By

McGill University Health Center

Verification Date

June 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.