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

Not Applicable

• Conditions: Liver Transplantation
• Interventions: Drug: Albumin infusion (25% albumin)

• Registration Number: NCT00842803
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-11
• Study First Submitted QC: 2009-02-11
• Study First Posted: 2009-02-12
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-17
• Last Update Posted: 2009-09-18
• Study Start: 2010-01
• Primary Completion: 2012-06
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Albumin group	Albumin infusion (25% albumin)	Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative

Primary Outcome Measures

Name	Time	Method
Post Transplant Liver Function Test (PTLFT)	Post-operative Day1 through 7 and Day 15,30, 45

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Royal Victoria Hospital; 🇨🇦 Montreal, Quebec, Canada