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Comparison of Priming Constituents in Patients Undergoing CPB Assisted Cardiac Surgery: HES 130/0.4 or Albumin 5%

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ClinicalTrials.gov Identifier: NCT01849757
Recruitment Status : Unknown
Verified May 2013 by Jo-Anne Marcoux, University of Saskatchewan.
Recruitment status was:  Not yet recruiting
First Posted : May 8, 2013
Last Update Posted : May 13, 2013
Sponsor:
Information provided by (Responsible Party):
Jo-Anne Marcoux, University of Saskatchewan

Brief Summary:
The purpose of the study is to determine which priming fluid is the safest for use for priming the heart-lung machine used during cardiopulmonary bypass for patients undergoing cardiac surgery. The fluids to be compared are albumin and voluven. A control group will receive only crystalloid.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Aortic Valve Disease Mitral Valve Disease Other: prime crystalloid Other: Human Albumin Other: Voluven Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Priming Constituents in Patients Undergoing CPB Assisted Cardiac Surgery: HES 130/0.4 or Albumin 5%
Study Start Date : November 2013
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Active Comparator: Human Albumin
Human albumin solution used as part of the priming volume for the cardiopulmonary bypass circuit.
Other: Human Albumin
Used as a constituent for priming the CPB circuit
Other Names:
  • Albumin 5%
  • Albumin 25%
Active Comparator: Voluven or hydroethylstarch HES 130/0.4
Hydroethylstarch HES 130/0.4 used as part of the priming volume for the cardiopulmonary bypass circuit.
Other: Voluven
Used as a constituent for priming the CPB circuit
Other Name: Hydroethylstarch HES130/0.4
Placebo Comparator: Crystalloid
Crystalloid will be used to prime the cardiopulmonary bypass circuit
Other: prime crystalloid
used for priming the CPB circuit
Other Names:
  • saline 0.9%
  • Normosol
  • Ringer's lactate
  • Plasmalyte



Primary Outcome Measures :
  1. Post-operative bleeding and transfusion requirements [ Time Frame: 24-48 hours post-operatively ]
    Postoperative cardiac patients have chest tubes in place which drain any blood oozing from around the pericardial cavity. The chest tubes are attached to a blood collection apparatus which measures the amount of blood loss. Too much post-operative blood loss results in a transfusion requirement of red blood cells, plasma and/or platelets.


Secondary Outcome Measures :
  1. renal function, creatinine levels [ Time Frame: 24-48 hours post-operatively ]
    Use of some colloids have been associated with a deterioration of renal function. Data will be collected post-operatively to determine he effect of the different priming fluids on renal function



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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

patients undergoing cardiopulmonary bypass assisted cardiac surgery

Exclusion Criteria:

emergencies and patients in renal failure or dialysis -


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): NCT01849757


Contacts
Contact: Jo-Anne E. Marcoux, M. Sc. 306-655-2128 laterreur2@yahoo.ca
Contact: Victor Uppal, B. Sc. 306-655-2128 victoruppal12@gmail.com

Locations
Canada, Saskatchewan
Royal University Hospital Not yet recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Marcoux    306-6552128      
Contact: Uppal    306-6552128      
Principal Investigator: Jo-Anne E Marcoux, M. Sc.         
Sponsors and Collaborators
University of Saskatchewan
Investigators
Principal Investigator: Jo-Anne E Marcocoux, M. Sc. Royal University Hospital Foundation
Principal Investigator: Jo-Anne E Marcoux, M. Sc. RUH

Publications:

Responsible Party: Jo-Anne Marcoux, Perfusionist M. Sc., CPC, CCP, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01849757     History of Changes
Other Study ID Numbers: ruh/westerncan/primestudy
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: May 2013

Keywords provided by Jo-Anne Marcoux, University of Saskatchewan:
Cardiopulmonary bypass
prime
crystalloid
albumin
HES 130/0.4

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases