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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. 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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00842803
First Posted: February 12, 2009
Last Update Posted: September 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
McGill University Health Center
  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
Intervention Model: Parallel Assignment
Masking: None (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Dr Peter Metrakos, MUHC
ClinicalTrials.gov Identifier: NCT00842803     History of Changes
Other Study ID Numbers: SDR-08-030
First Submitted: February 11, 2009
First Posted: February 12, 2009
Last Update Posted: September 18, 2009
Last Verified: September 2009

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