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

McGill University

Status and phase: Unknown; Phase 4

Conditions: Other Complications of Liver Transplant

Treatments: Drug: 25% albumin; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01328132

10-287-BMA

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Saline

Active Comparator group

Treatment:

Drug: Saline

25% albumin

Experimental group

Treatment:

Drug: 25% albumin