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

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ClinicalTrials.gov Identifier: NCT00337805
Recruitment Status : Completed
First Posted : June 16, 2006
Last Update Posted : September 18, 2009
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Cardiac Surgery Other: Pentaspan Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2004
Primary Completion Date : December 2007
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Use of catecholamines at 8:00 the morning after surgery [ Time Frame: first post operative day ]

Secondary Outcome Measures :
  1. Total use of catecholamines [ Time Frame: Time in ICU ]
  2. Time in the ICU [ Time Frame: Time in ICU ]
  3. Post-operative complications [ Time Frame: Hospital stay or 28 days ]
  4. Bleeding [ Time Frame: Hospital stay or 28 days ]
  5. Renal failure [ Time Frame: Hospital stay or 28 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00337805

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr S Magder, McGill University
ClinicalTrials.gov Identifier: NCT00337805     History of Changes
Other Study ID Numbers: BMA-04-016
First Posted: June 16, 2006    Key Record Dates
Last Update Posted: September 18, 2009
Last Verified: September 2009

Keywords provided by McGill University Health Center:

Additional relevant MeSH terms:
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes