Effect of Hyperoncotic Albumin on Vascular Hemodynamics and Oxygen Delivery Following Orthotopic Liver Transplant

March 31, 2011 updated by: McGill University Health Centre/Research Institute of the McGill University Health Centre
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3A1A1
        • Royal Victoria Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older
  • Patients from the Critical care Unit
  • Patients with a pulmonary artery occlusion catheter Inclusion:patients immediately following liver transplantation

Exclusion Criteria:

  • Patients not giving informed consent
  • Patients who have received > 300 ml of albumin within 24 hours prior to inclusion
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Saline
Drug: Saline
100 ml of saline will be given in addition to the standard of care every 8 hours for 24 hours.
Experimental: 25% albumin
Drug: 25% albumin
100 ml of 25% albumin will be given in addition to the standard of care every 8 hours for 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac index (CI)
Time Frame: 60 minutes after the infusion of the fluid
60 minutes after the infusion of the fluid

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac function response
Time Frame: 30 and 60 minutes after the infusion of the fluid
An improvement in Q due primarily to a change in cardiac function should have an increase in Q of ≥ 0.3 ml/min/m2/mmHg
30 and 60 minutes after the infusion of the fluid
A decrease in leak and plasma expansion
Time Frame: 30 and 60 minutes after the infusion of the fluid
A decrease in leak and plasma expansion will be determined by the Harrison formula for calculating a change in plasma volume from the change in Hb and change in Hct
30 and 60 minutes after the infusion of the fluid
Cardiac output response
Time Frame: 30 and 60 minutes after the infusion of the fluid
Cardiac output response primarily due to a "volume effect" would be expected to have an increase of CVP of a minimum of 2 mmHg and an increase in CI of > 0.3 L/min/m2 per mmHg.
30 and 60 minutes after the infusion of the fluid
Detoxification effect of albumin
Time Frame: 30 and 60 minutes after infusion
A increase in vascular tone will be identified by an increase in systemic vascular resistance or a rise in blood pressure without a change in cardiac output or a rise in blood pressure with a fall in cardiac output
30 and 60 minutes after infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Sheldon Magder, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

October 1, 2011

Study Registration Dates

First Submitted

March 31, 2011

First Submitted That Met QC Criteria

March 31, 2011

First Posted (Estimate)

April 4, 2011

Study Record Updates

Last Update Posted (Estimate)

April 4, 2011

Last Update Submitted That Met QC Criteria

March 31, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10-287-BMA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Other Complications of Liver Transplant

Clinical Trials on Saline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe