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

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

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

Conditions
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Liver Transplantation

Intervention / Treatment
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* Drug: Albumin infusion (25% albumin)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Patients in this group will not be allowed albumin or any other colloids fluid for the first 7 days post-operative | |
| Experimental: Albumin group<br>Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative | Drug: Albumin infusion (25% albumin)<br>* Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver, transplant, albumin, outcome, Liver transplant recipients canadian transplant status 1 or 2