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

NCT ID: NCT00842803

Last Updated: 2009-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-06-30

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.

Detailed Description

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Conditions

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Liver Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control Group

Patients in this group will not be allowed albumin or any other colloids fluid for the first 7 days post-operative

Group Type NO_INTERVENTION

No interventions assigned to this group

Albumin group

Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative

Group Type EXPERIMENTAL

Albumin infusion (25% albumin)

Intervention Type DRUG

Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative

Interventions

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Albumin infusion (25% albumin)

Patients in this arm will receive albumin infusions 3 times a day for the first 7 days post-operative

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role lead

Responsible Party

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MUHC

Locations

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Royal Victoria Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Central Contacts

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Mathieu Rousseau, MD

Role: CONTACT

514.567.0292

Mazen Hassanain, MD

Role: CONTACT

514.934.1934 ext. 31600

Other Identifiers

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SDR-08-030

Identifier Type: -

Identifier Source: org_study_id

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