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

March 31, 2011
March 31, 2011
March 2011
October 2011   (final data collection date for primary outcome measure)
Cardiac index (CI) [ Time Frame: 60 minutes after the infusion of the fluid ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Effect of Hyperoncotic Albumin on Vascular Hemodynamics and Oxygen Delivery Following Orthotopic Liver Transplant
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Other Complications of Liver Transplant
  • Drug: Saline
    100 ml of saline will be given in addition to the standard of care every 8 hours for 24 hours.
  • Drug: 25% albumin
    100 ml of 25% albumin will be given in addition to the standard of care every 8 hours for 24 hours
  • Active Comparator: Saline
    Intervention: Drug: Saline
  • Experimental: 25% albumin
    Intervention: Drug: 25% albumin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
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
Canada
 
NCT01328132
10-287-BMA
No
Sheldon Magder, MD, McGill University Health Center
McGill University Health Center
Not Provided
Principal Investigator: Sheldon Magder, MD McGill University Health Center
McGill University Health Center
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP