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

Other Complications of Liver Transplant Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01328132
• Other study ID #: 10-287-BMA
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 31, 2011
• Last updated: March 31, 2011
• Start date: March 2011
• Est. completion date: October 2011

Study information

• Verified date: January 2011
• Source: McGill University Health Center
• Contact: Sheldon Magder, MD
• Phone: 514-934-1934
• Email: sheldon.magder[@]muhc.mcgill.ca
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health ResearchCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Other Complications of Liver Transplant

Intervention

Drug:
• Saline
100 ml of saline will be given in addition to the standard of care every 8 hours for 24 hours.
• 25% albumin
100 ml of 25% albumin will be given in addition to the standard of care every 8 hours for 24 hours

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac index (CI)		60 minutes after the infusion of the fluid	No
Secondary	Cardiac function response	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	No
Secondary	A decrease in leak and plasma expansion	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	No
Secondary	Cardiac output response	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	No
Secondary	Detoxification effect of albumin	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	No