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

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ClinicalTrials.gov Identifier: NCT01328132
Recruitment Status : Unknown
Verified January 2011 by McGill University Health Center.
Recruitment status was:  Not yet recruiting
First Posted : April 4, 2011
Last Update Posted : April 4, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Other Complications of Liver Transplant Drug: Saline Drug: 25% albumin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2011
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : October 2011

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Cardiac index (CI) [ Time Frame: 60 minutes after the infusion of the fluid ]

Secondary Outcome Measures :
  1. Cardiac function response [ Time Frame: 30 and 60 minutes after the infusion of the fluid ]
    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

  2. A decrease in leak and plasma expansion [ Time Frame: 30 and 60 minutes after the infusion of the fluid ]
    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

  3. Cardiac output response [ Time Frame: 30 and 60 minutes after the infusion of the fluid ]
    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.

  4. Detoxification effect of albumin [ Time Frame: 30 and 60 minutes after infusion ]
    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


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Sheldon Magder, MD, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01328132     History of Changes
Other Study ID Numbers: 10-287-BMA
First Posted: April 4, 2011    Key Record Dates
Last Update Posted: April 4, 2011
Last Verified: January 2011

Keywords provided by McGill University Health Center:
Liver
transplant
albumin