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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by University of Saskatchewan
Sponsor:
Information provided by (Responsible Party):
Jo-Anne Marcoux, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01849757
First received: May 6, 2013
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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 Intervention
Coronary Artery Disease
Aortic Valve Disease
Mitral Valve Disease
Other: prime crystalloid
Other: Human Albumin
Other: Voluven

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Priming Constituents in Patients Undergoing CPB Assisted Cardiac Surgery: HES 130/0.4 or Albumin 5%

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Post-operative bleeding and transfusion requirements [ Time Frame: 24-48 hours post-operatively ] [ Designated as safety issue: Yes ]
    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:
  • renal function, creatinine levels [ Time Frame: 24-48 hours post-operatively ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 7000
Study Start Date: November 2013
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

patients undergoing cardiopulmonary bypass assisted cardiac surgery

-

Exclusion Criteria:

emergencies and patients in renal failure or dialysis -

  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: 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
  More Information

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
Study First Received: May 6, 2013
Last Updated: May 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Saskatchewan:
Cardiopulmonary bypass
prime
crystalloid
albumin
HES 130/0.4

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Defects, Congenital
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Albunex
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014