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Post-Operative Use of Salt Poor Albumin Solution in Resuscitation of Orthotopic Liver Transplant

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by McGill University Health Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00842803
First received: February 11, 2009
Last updated: September 17, 2009
Last verified: September 2009
History of Changes
  Purpose

The purpose of the study is to examine if outcome after liver transplantation is improved by using albumin infusion post-transplantation.


Condition Intervention
Liver Transplantation
 Drug: Albumin infusion (25% albumin)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Post-Operative Use of Salt Poor Albumin Solution in Resuscitation of Orthotopic Liver Transplant Recipients Status 1-2. A Prospective Randomized Controlled Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Post Transplant Liver Function Test (PTLFT) [ Time Frame: Post-operative Day1 through 7 and Day 15,30, 45 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional 6 minutes walking test [ Time Frame: Post-operative ] [ Designated as safety issue: No ]
  • Calculated creatinine clearance [ Time Frame: Post-operative day 1, 7, 15, 30, 45 ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: post-operative ] [ Designated as safety issue: No ]
  • ICU length of stay [ Time Frame: post-operative ] [ Designated as safety issue: No ]
  • duration of mechanical ventilation [ Time Frame: post-operative ] [ Designated as safety issue: No ]
  • duration of renal replacement therapy [ Time Frame: postoperative ] [ Designated as safety issue: No ]
  • ICU readmission rate [ Time Frame: post-operative ] [ Designated as safety issue: No ]
  • reintubation rate [ Time Frame: post-operative ] [ Designated as safety issue: No ]
  • Post-operative infection rate [ Time Frame: Post-operative ] [ Designated as safety issue: No ]
  • Need to re-operation unrelated to technical complication [ Time Frame: post-operative ] [ Designated as safety issue: No ]
  • Functional hand grip Jamar Dynamometer hand grip test [ Time Frame: Post-op day 7, 15, 30 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
Patients in this group will not be allowed albumin or any other colloids fluid for the first 7 days post-operative
Experimental: Albumin group
Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative
 Drug: Albumin infusion (25% albumin)
Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Canadian Transplant status 1 or 2
  • Patients at the Royal Victoria Hospital, Montreal, Canada

Exclusion Criteria:

  • Emergency liver transplant (canadian transplant status 3 or 4)
  • patients who have received more than 300cc of albumin within 48 hours prior to transplant
  • patients who underwent previous solid organ transplant
  • multi-organs transplant recipients
  • patients who had previous adverse reaction to human albumin solution
  • patients who have religious restriction to receiving human blood products.
  • patients or surrogate unable to give consent to the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842803

Contacts
Contact: Mathieu Rousseau, MD 514.567.0292 mathieu.rousseau@mail.mcgill.ca
Contact: Mazen Hassanain, MD 514.934.1934 ext 31600 mazen.hassanain@muhc.mcgill.ca

Locations
Canada, Quebec
Royal Victoria Hospital Not yet recruiting
Montreal, Quebec, Canada, H3A1A1
Sponsors and Collaborators
McGill University Health Center
  More Information

No publications provided

Responsible Party: Dr Peter Metrakos, MUHC
ClinicalTrials.gov Identifier: NCT00842803     History of Changes
Other Study ID Numbers: SDR-08-030
Study First Received: February 11, 2009
Last Updated: September 17, 2009
Health Authority: Canada: Health Canada

Keywords provided by McGill University Health Center:
Liver
transplant
albumin
outcome
Liver transplant recipients canadian transplant status 1 or 2

ClinicalTrials.gov processed this record on June 17, 2013