Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery
A Randomized Trial of Synthetic vs Normal Saline for the Flow-based Algorithmic Hemodynamic Resuscitation of Patients Post-cardiac Surgery
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2004
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 14, 2006
CompletedFirst Posted
Study publicly available on registry
June 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedSeptember 18, 2009
September 1, 2009
3.2 years
June 14, 2006
September 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Use of catecholamines at 8:00 the morning after surgery
first post operative day
Secondary Outcomes (5)
Total use of catecholamines
Time in ICU
Time in the ICU
Time in ICU
Post-operative complications
Hospital stay or 28 days
Bleeding
Hospital stay or 28 days
Renal failure
Hospital stay or 28 days
Study Arms (2)
1 colloid
ACTIVE COMPARATORBoluses of fluids are a pentastarch (up to 1000 ml)
2. Crytalloid
ACTIVE COMPARATORBoluses are given as normal saline
Interventions
When fluids are indicated either pentaspan or saline are given in a double blind randomized assignment
Eligibility Criteria
You may qualify if:
- status post cardiac surgery
- pulmonary artery occlusion catheter in place
- informed consent
- morning case (must be out of OR by 2:00 PM
You may not qualify if:
- excessive bleeding (\> 200 cc/hr)
- intraaortic balloon pump
- refusal by treating team
- emergency cases
- patients with known adverse reactions to starch solutions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Related Publications (1)
Potter BJ, Deverenne B, Doucette S, Fergusson D, Magder S; Canadian Critical Care Trials Group. Cardiac output responses in a flow-driven protocol of resuscitation following cardiac surgery. J Crit Care. 2013 Jun;28(3):265-9. doi: 10.1016/j.jcrc.2012.09.008. Epub 2012 Nov 14.
PMID: 23159133DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
sheldon magder, md
McGill University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 14, 2006
First Posted
June 16, 2006
Study Start
September 1, 2004
Primary Completion
December 1, 2007
Study Completion
April 1, 2008
Last Updated
September 18, 2009
Record last verified: 2009-09