Volume Kinetics for Hyperoncotic Albumin in Burn Patients as Well as for Healthy Subjects

Study Overview
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Brief Summary
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Treatment with colloidal solutions has during long time been a cornerstone within intensive care. Lately, doubts have been raised about synthetic colloids, and the natural albumin has been used more and more. One of these solutions is the hyperoncotic Albumin 20%. However there are still many aspects of the physiological effects of hyperoncotic albumin, that are not known. In this study physiological effects will be studied in burn patients and healthy subjects. The colloid osmotic pressure and the increase of the plasma volume will be measured in 15 healthy subjects and in 15 burn patients. The effect on the plasma volume will be studied using hemoglobin as a marker of dilution. Colloids osmotic pressure and albumin concentration will be measured directly and urin production will also be measured. Blood samples will be collected during 4 to 5 hours to achieve a profile over the changes.

Detailed Description
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Healthy individuals are asked to refrain from eating and drinking the night before the study. Two hours before study start, the subjects may take a sandwich and a glas to drink. Patients will also be asked to keep the same rules unless they receive parenteral nutrition. Shortly before the study, the subjects are asked to leave an urine sample. After 15 minutes of rest the first bood samples are taken. An infusion 3 ml/kg bodyweight Albumin 20% is given during 30 minutes. The first hour after study start (start of infusion) blood samples are taken every 10 minutes. The following 4 hours another 9 blood samples are collected. Hemoglobin, albumin and colloidosmotic pressure will be measured at every occasion. C-reactive protein, interleukin-6, Syndecan -1 as well as heparan sulfate, will be measured before, after 1 hour and 5 hours after study start. The total volume of blood collected will be 150 ml. If the study subjects have a low urin output, acetated Ringers will be given at the end of the study. Liberal fluid intake is recommended the same day and the next.

Official Title
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Volume Kinetics for Hyperoncotic Albumin in Burn Patients as Well as for Healthy Subjects

Conditions
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Burns

Intervention / Treatment
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* Drug: Albumins


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For healthy individuals: Healthy, without allergies and with the age of 18 years or above. For patients: Burn injury exceeding 6-8 Total Burned Surface Area % Exclusion Criteria: Heart failure Signs of kidney injury/failure Severe allergies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Burn patients<br>Patients with burns exceeding 6-8 Total Burned Surface Area % | Drug: Albumins<br>* Infusion of 3ml/kg bodyweight of hyperoncotic albumin 20% during 30 minutes.<br>* Other names: Albumin 20%;|
| Experimental: Healthy individuals<br>Healthy individuals without allergies. | Drug: Albumins<br>* Infusion of 3ml/kg bodyweight of hyperoncotic albumin 20% during 30 minutes.<br>* Other names: Albumin 20%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma volume | Plasma volume expansion using hemoglobin as a marker of dilution. | 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colloid osmotic pressure | Effect of hyperoncotic albumin on oncotic pressure. | 5 hours |