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Completed

NCT Number: NCT00337805

Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After 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.

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Key information

Conditions

Cardiac Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pentaspan

Other

When fluids are indicated either pentaspan or saline are given in a double blind randomized assignment

Primary outcomes

  1. Use of catecholamines at 8:00 the morning after surgery

    Time frame: first post operative day

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Jun 16, 2006
Registry last updated
Sep 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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