Post-Operative Use of Salt Poor Albumin Solution in Resuscitation of Orthotopic Liver Transplant
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of the study is to examine if outcome after liver transplantation is improved by using albumin infusion post-transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2009
CompletedFirst Posted
Study publicly available on registry
February 12, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedSeptember 18, 2009
September 1, 2009
2.4 years
February 11, 2009
September 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post Transplant Liver Function Test (PTLFT)
Post-operative Day1 through 7 and Day 15,30, 45
Secondary Outcomes (11)
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
- +6 more secondary outcomes
Study Arms (2)
Control Group
NO INTERVENTIONPatients in this group will not be allowed albumin or any other colloids fluid for the first 7 days post-operative
Albumin group
EXPERIMENTALPatients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative
Interventions
Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative
Eligibility Criteria
You may qualify if:
- years or older
- Canadian Transplant status 1 or 2
- Patients at the Royal Victoria Hospital, Montreal, Canada
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Victoria Hospital
Montreal, Quebec, H3A1A1, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 11, 2009
First Posted
February 12, 2009
Study Start
January 1, 2010
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
September 18, 2009
Record last verified: 2009-09