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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00337805
First received: June 14, 2006
Last updated: September 17, 2009
Last verified: September 2009
  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
Other: Pentaspan
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Synthetic vs Normal Saline for the Flow-based Algorithmic Hemodynamic Resuscitation of Patients Post-cardiac Surgery

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Use of catecholamines at 8:00 the morning after surgery [ Time Frame: first post operative day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total use of catecholamines [ Time Frame: Time in ICU ] [ Designated as safety issue: No ]
  • Time in the ICU [ Time Frame: Time in ICU ] [ Designated as safety issue: No ]
  • Post-operative complications [ Time Frame: Hospital stay or 28 days ] [ Designated as safety issue: Yes ]
  • Bleeding [ Time Frame: Hospital stay or 28 days ] [ Designated as safety issue: Yes ]
  • Renal failure [ Time Frame: Hospital stay or 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 240
Study Start Date: September 2004
Study Completion Date: April 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
McGill University Health Center
Bristol-Myers Squibb
Investigators
Principal Investigator: sheldon magder, md McGill University
  More Information

No publications provided

Responsible Party: Dr S Magder, McGill University
ClinicalTrials.gov Identifier: NCT00337805     History of Changes
Other Study ID Numbers: BMA-04-016
Study First Received: June 14, 2006
Last Updated: September 17, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
colloid
crystalloid
hemodynamics
flow-directed
resuscitation

ClinicalTrials.gov processed this record on October 02, 2014