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

September 17, 2009 updated by: McGill University Health Centre/Research Institute of the McGill University Health Centre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Royal Victoria Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1 colloid
Boluses of fluids are a pentastarch (up to 1000 ml)
Other: Pentaspan
When fluids are indicated either pentaspan or saline are given in a double blind randomized assignment
Active Comparator: 2. Crytalloid
Boluses are given as normal saline
Other: Pentaspan
When fluids are indicated either pentaspan or saline are given in a double blind randomized assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Use of catecholamines at 8:00 the morning after surgery
Time Frame: first post operative day
first post operative day

Secondary Outcome Measures

Outcome Measure
Time Frame
Total use of catecholamines
Time Frame: Time in ICU
Time in ICU
Time in the ICU
Time Frame: Time in ICU
Time in ICU
Post-operative complications
Time Frame: Hospital stay or 28 days
Hospital stay or 28 days
Bleeding
Time Frame: Hospital stay or 28 days
Hospital stay or 28 days
Renal failure
Time Frame: Hospital stay or 28 days
Hospital stay or 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: sheldon magder, md, McGill University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

June 14, 2006

First Submitted That Met QC Criteria

June 14, 2006

First Posted (Estimate)

June 16, 2006

Study Record Updates

Last Update Posted (Estimate)

September 18, 2009

Last Update Submitted That Met QC Criteria

September 17, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMA-04-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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