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

Phase 4

• Conditions: Other Complications of Liver Transplant
• Interventions: Drug: Saline; Drug: 25% albumin

• Registration Number: NCT01328132
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2011-01
• Study Start: 2011-03
• Study First Submitted: 2011-03-31
• Study First Submitted QC: 2011-03-31
• Last Update Submitted: 2011-03-31
• Study First Posted: 2011-04-04
• Last Update Posted: 2011-04-04
• Primary Completion: 2011-10
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline	Saline	-
25% albumin	25% albumin	-

Primary Outcome Measures

Name	Time	Method
Cardiac index (CI)	60 minutes after the infusion of the fluid

Secondary Outcome Measures

Name	Time	Method
Cardiac function response	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
A decrease in leak and plasma expansion	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
Cardiac output response	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.
Detoxification effect of albumin	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

Trial Locations

Locations (1)

Royal Victoria Hospital; 🇨🇦 Montreal, Quebec, Canada