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

September 17, 2009 updated by: McGill University Health Centre/Research Institute of the McGill University Health Centre

Post-Operative Use of Salt Poor Albumin Solution in Resuscitation of Orthotopic Liver Transplant Recipients Status 1-2. A Prospective Randomized Controlled Trial.

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A1A1
        • Royal Victoria Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post Transplant Liver Function Test (PTLFT)
Time Frame: Post-operative Day1 through 7 and Day 15,30, 45
Post-operative Day1 through 7 and Day 15,30, 45

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

February 11, 2009

First Submitted That Met QC Criteria

February 11, 2009

First Posted (Estimate)

February 12, 2009

Study Record Updates

Last Update Posted (Estimate)

September 18, 2009

Last Update Submitted That Met QC Criteria

September 17, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SDR-08-030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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