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

NCT ID: NCT01328132

Last Updated: 2011-04-04

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Other Complications of Liver Transplant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Saline

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type DRUG

100 ml of saline will be given in addition to the standard of care every 8 hours for 24 hours.

25% albumin

Group Type EXPERIMENTAL

25% albumin

Intervention Type DRUG

100 ml of 25% albumin will be given in addition to the standard of care every 8 hours for 24 hours

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Saline

100 ml of saline will be given in addition to the standard of care every 8 hours for 24 hours.

Intervention Type DRUG

25% albumin

100 ml of 25% albumin will be given in addition to the standard of care every 8 hours for 24 hours

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

McGill University Health Center

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sheldon Magder, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royal Victoria Hospital

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sheldon Magder, MD

Role: CONTACT

514-934-1934 ext. 35253

Thomas Lescot, MD, PhD

Role: CONTACT

514-934-1934 ext. 36736

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10-287-BMA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.