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

Phase 4

Completed

• Conditions: Burns
• Interventions: Drug: Albumins

• Registration Number: NCT02952378
• Lead Sponsor: University Hospital, Linkoeping

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-02
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-25
• Last Update Posted: 2019-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Burn patients	Albumins	Patients with burns exceeding 6-8 Total Burned Surface Area %
Healthy individuals	Albumins	Healthy individuals without allergies.

Primary Outcome Measures

Name	Time	Method
Plasma volume	5 hours	Plasma volume expansion using hemoglobin as a marker of dilution.

Secondary Outcome Measures

Name	Time	Method
Colloid osmotic pressure	5 hours	Effect of hyperoncotic albumin on oncotic pressure.

Trial Locations

Locations (1)

Burn ward, University Hospital, Linköping; 🇸🇪 Linkoping, Sweden