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

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00842803
• Other study ID #: SDR-08-030
• Status: Not yet recruiting
• Phase: N/A
• First received: February 11, 2009
• Last updated: September 17, 2009
• Start date: January 2010
• Est. completion date: June 2012

Study information

• Verified date: September 2009
• Source: McGill University Health Center
• Contact: Mathieu Rousseau, MD
• Phone: 514.567.0292
• Email: mathieu.rousseau[@]mail.mcgill.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• Albumin infusion (25% albumin)
Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Transplant Liver Function Test (PTLFT)		Post-operative Day1 through 7 and Day 15,30, 45	No
Secondary	Functional 6 minutes walking test		Post-operative	No
Secondary	Calculated creatinine clearance		Post-operative day 1, 7, 15, 30, 45	No
Secondary	Length of hospital stay		post-operative	No
Secondary	ICU length of stay		post-operative	No
Secondary	duration of mechanical ventilation		post-operative	No
Secondary	duration of renal replacement therapy		postoperative	No
Secondary	ICU readmission rate		post-operative	No
Secondary	reintubation rate		post-operative	No
Secondary	Post-operative infection rate		Post-operative	No
Secondary	Need to re-operation unrelated to technical complication		post-operative	No
Secondary	Functional hand grip Jamar Dynamometer hand grip test		Post-op day 7, 15, 30	No