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Effect of Hyperoncotic Albumin on Vascular Hemodynamics and Oxygen Delivery Following Orthotopic Liver Transplant

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by McGill University Health Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01328132
First received: March 31, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

The primary aim of this study is to assess the effect of hyperoncotic albumin on vascular hemodynamics and oxygen delivery after orthotopic liver transplant. The secondary aim is to try to identify the dominant physiological mechanism so that we will be able to better identify patients that may benefit from the use of albumin (25%) boluses in addition to standard care in patients following liver transplantation.


Condition Intervention Phase
Other Complications of Liver Transplant
 Drug: Saline
Drug: 25% albumin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Cardiac index (CI) [ Time Frame: 60 minutes after the infusion of the fluid ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiac function response [ Time Frame: 30 and 60 minutes after the infusion of the fluid ] [ Designated as safety issue: No ]
    An improvement in Q due primarily to a change in cardiac function should have an increase in Q of ≥ 0.3 ml/min/m2/mmHg

  • A decrease in leak and plasma expansion [ Time Frame: 30 and 60 minutes after the infusion of the fluid ] [ Designated as safety issue: No ]
    A decrease in leak and plasma expansion will be determined by the Harrison formula for calculating a change in plasma volume from the change in Hb and change in Hct

  • Cardiac output response [ Time Frame: 30 and 60 minutes after the infusion of the fluid ] [ Designated as safety issue: No ]
    Cardiac output response primarily due to a "volume effect" would be expected to have an increase of CVP of a minimum of 2 mmHg and an increase in CI of > 0.3 L/min/m2 per mmHg.

  • Detoxification effect of albumin [ Time Frame: 30 and 60 minutes after infusion ] [ Designated as safety issue: No ]
    A increase in vascular tone will be identified by an increase in systemic vascular resistance or a rise in blood pressure without a change in cardiac output or a rise in blood pressure with a fall in cardiac output


Estimated Enrollment: 20
Study Start Date: March 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Saline Drug: Saline
100 ml of saline will be given in addition to the standard of care every 8 hours for 24 hours.
Experimental: 25% albumin Drug: 25% albumin
100 ml of 25% albumin will be given in addition to the standard of care every 8 hours for 24 hours

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Patients from the Critical care Unit
  • Patients with a pulmonary artery occlusion catheter Inclusion:patients immediately following liver transplantation

Exclusion Criteria:

  • Patients not giving informed consent
  • Patients who have received > 300 ml of albumin within 24 hours prior to inclusion
  • Patients known to have previous adverse reaction to human albumin solution
  • Patients who have religious restriction to receive human blood products
  • Patient who have initial graft failure
  • Patients with fluctuating hemodynamics
  • Concerns of the treating surgeon
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328132

Contacts
Contact: Sheldon Magder, MD 514-934-1934 ext 35253 sheldon.magder@muhc.mcgill.ca
Contact: Thomas Lescot, MD, PhD 514-934-1934 ext 36736 thomas.lescot@mail.mcgill.ca

Locations
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A1A1
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Sheldon Magder, MD McGill University Health Center
  More Information

No publications provided

Responsible Party: Sheldon Magder, MD, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01328132     History of Changes
Other Study ID Numbers: 10-287-BMA
Study First Received: March 31, 2011
Last Updated: March 31, 2011
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
Liver
transplant
albumin

ClinicalTrials.gov processed this record on June 17, 2013