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

Burns Clinical Trial

— VAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02952378
• Other study ID #: VAB
• Status: Completed
• Phase: Phase 4
• Start date: October 2016
• Est. completion date: January 31, 2019

Study information

• Verified date: May 2019
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns

Intervention

Drug:
• Albumins
Infusion of 3ml/kg bodyweight of hyperoncotic albumin 20% during 30 minutes.

Locations

Country	Name	City	State
Sweden	Burn ward, University Hospital, Linköping	Linkoping

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma volume	Plasma volume expansion using hemoglobin as a marker of dilution.	5 hours
Secondary	Colloid osmotic pressure	Effect of hyperoncotic albumin on oncotic pressure.	5 hours