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

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.

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Drug: Albumins

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Linkoping, Sweden, 58185
    • Burn ward, University Hospital, Linköping

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping
• Investigators: Principal Investigator: Joachim Zdolsek, MD,PhD,Assoc prof, University Hospital, Linkoeping

Publications and helpful links

General Publications

• Hahn RG, Zdolsek M, Krizhanovskii C, Ntika S, Zdolsek J. Elevated Plasma Concentrations of Syndecan-1 Do Not Correlate With Increased Capillary Leakage of 20% Albumin. Anesth Analg. 2021 Mar 1;132(3):856-865. doi: 10.1213/ANE.0000000000005315.
• Zdolsek M, Hahn RG, Sjoberg F, Zdolsek JH. Plasma volume expansion and capillary leakage of 20% albumin in burned patients and volunteers. Crit Care. 2020 May 5;24(1):191. doi: 10.1186/s13054-020-02855-0.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: November 1, 2016
• First Posted (Estimate): November 2, 2016

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 25, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: VAB