Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by McGill University Health Center.
Recruitment status was:  Not yet recruiting
Information provided by:
McGill University Health Center Identifier:
First received: February 11, 2009
Last updated: September 17, 2009
Last verified: September 2009
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
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:

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 ]

Secondary Outcome Measures:
  • Functional 6 minutes walking test [ Time Frame: Post-operative ]
  • Calculated creatinine clearance [ Time Frame: Post-operative day 1, 7, 15, 30, 45 ]
  • Length of hospital stay [ Time Frame: post-operative ]
  • ICU length of stay [ Time Frame: post-operative ]
  • duration of mechanical ventilation [ Time Frame: post-operative ]
  • duration of renal replacement therapy [ Time Frame: postoperative ]
  • ICU readmission rate [ Time Frame: post-operative ]
  • reintubation rate [ Time Frame: post-operative ]
  • Post-operative infection rate [ Time Frame: Post-operative ]
  • Need to re-operation unrelated to technical complication [ Time Frame: post-operative ]
  • Functional hand grip Jamar Dynamometer hand grip test [ Time Frame: Post-op day 7, 15, 30 ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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 identifier: NCT00842803

Contact: Mathieu Rousseau, MD 514.567.0292
Contact: Mazen Hassanain, MD 514.934.1934 ext 31600

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

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

Keywords provided by McGill University Health Center:
Liver transplant recipients canadian transplant status 1 or 2 processed this record on May 24, 2017