Effect of Hyperoncotic Albumin on Vascular Hemodynamics and Oxygen Delivery Following Orthotopic Liver Transplant
1 other identifier
interventional
20
1 country
1
Brief Summary
The primary aim of this study is to assess the effect of hyperoncotic albumin on vascular hemodynamics and oxygen delivery after orthotopic liver transplant. The secondary aim is to try to identify the dominant physiological mechanism so that we will be able to better identify patients that may benefit from the use of albumin (25%) boluses in addition to standard care in patients following liver transplantation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2011
Shorter than P25 for phase_4
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
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 31, 2011
CompletedFirst Posted
Study publicly available on registry
April 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedApril 4, 2011
January 1, 2011
7 months
March 31, 2011
March 31, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cardiac index (CI)
60 minutes after the infusion of the fluid
Secondary Outcomes (4)
Cardiac function response
30 and 60 minutes after the infusion of the fluid
A decrease in leak and plasma expansion
30 and 60 minutes after the infusion of the fluid
Cardiac output response
30 and 60 minutes after the infusion of the fluid
Detoxification effect of albumin
30 and 60 minutes after infusion
Study Arms (2)
Saline
ACTIVE COMPARATOR25% albumin
EXPERIMENTALInterventions
100 ml of saline will be given in addition to the standard of care every 8 hours for 24 hours.
100 ml of 25% albumin will be given in addition to the standard of care every 8 hours for 24 hours
Eligibility Criteria
You may qualify if:
- years or older
- Patients from the Critical care Unit
You may not qualify if:
- Patients not giving informed consent
- Patients known to have previous adverse reaction to human albumin solution
- Patients who have religious restriction to receive human blood products
- Patient who have initial graft failure
- Patients with fluctuating hemodynamics
- Concerns of the treating surgeon
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)
Study Officials
- PRINCIPAL INVESTIGATOR
Sheldon Magder, MD
McGill University Health Centre/Research Institute of the McGill University Health Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 31, 2011
First Posted
April 4, 2011
Study Start
March 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
April 4, 2011
Record last verified: 2011-01