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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01328132
Enrollment
20
Registered
2011-04-04
Start date
2011-03-31
Completion date
2011-10-31
Last updated
2011-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other Complications of Liver Transplant

Keywords

Liver, transplant, albumin

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.

Interventions

DRUGSaline

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

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Cardiac index (CI)60 minutes after the infusion of the fluid

Secondary

MeasureTime frameDescription
Cardiac function response30 and 60 minutes after the infusion of the fluidAn 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 expansion30 and 60 minutes after the infusion of the fluidA 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 response30 and 60 minutes after the infusion of the fluidCardiac 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 albumin30 and 60 minutes after infusionA 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

Countries

Canada

Contacts

Primary ContactSheldon Magder, MD
sheldon.magder@muhc.mcgill.ca514-934-1934
Backup ContactThomas Lescot, MD, PhD
thomas.lescot@mail.mcgill.ca514-934-1934

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026