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

Study Overview
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Brief Summary
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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.

Conditions
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Other Complications of Liver Transplant

Intervention / Treatment
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* Drug: Saline
* Drug: 25% albumin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Saline<br> | Drug: Saline<br>* 100 ml of saline will be given in addition to the standard of care every 8 hours for 24 hours.<br>|
| Experimental: 25% albumin<br> | Drug: 25% albumin<br>* 100 ml of 25% albumin will be given in addition to the standard of care every 8 hours for 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac index (CI) |  | 60 minutes after the infusion of the fluid | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver, transplant, albumin