Volume Kinetics for Hyperoncotic Albumin in Burn Patients as Well as for Healthy Subjects (VAB)
Primary Purpose
Burns
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Albumins
Sponsored by
About this trial
This is an interventional treatment trial for Burns
Eligibility Criteria
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
Sites / Locations
- Burn ward, University Hospital, Linköping
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Burn patients
Healthy individuals
Arm Description
Patients with burns exceeding 6-8 Total Burned Surface Area %
Healthy individuals without allergies.
Outcomes
Primary Outcome Measures
Plasma volume
Plasma volume expansion using hemoglobin as a marker of dilution.
Secondary Outcome Measures
Colloid osmotic pressure
Effect of hyperoncotic albumin on oncotic pressure.
Full Information
NCT ID
NCT02952378
First Posted
October 31, 2016
Last Updated
May 25, 2019
Sponsor
University Hospital, Linkoeping
1. Study Identification
Unique Protocol Identification Number
NCT02952378
Brief Title
Volume Kinetics for Hyperoncotic Albumin in Burn Patients as Well as for Healthy Subjects
Acronym
VAB
Official Title
Volume Kinetics for Hyperoncotic Albumin in Burn Patients as Well as for Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Burn patients
Arm Type
Experimental
Arm Description
Patients with burns exceeding 6-8 Total Burned Surface Area %
Arm Title
Healthy individuals
Arm Type
Experimental
Arm Description
Healthy individuals without allergies.
Intervention Type
Drug
Intervention Name(s)
Albumins
Other Intervention Name(s)
Albumin 20%
Intervention Description
Infusion of 3ml/kg bodyweight of hyperoncotic albumin 20% during 30 minutes.
Primary Outcome Measure Information:
Title
Plasma volume
Description
Plasma volume expansion using hemoglobin as a marker of dilution.
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
Colloid osmotic pressure
Description
Effect of hyperoncotic albumin on oncotic pressure.
Time Frame
5 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joachim Zdolsek, MD,PhD,Assoc prof
Organizational Affiliation
University Hospital, Linkoeping
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burn ward, University Hospital, Linköping
City
Linkoping
ZIP/Postal Code
58185
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
33350618
Citation
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.
Results Reference
derived
PubMed Identifier
32366324
Citation
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.
Results Reference
derived
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Volume Kinetics for Hyperoncotic Albumin in Burn Patients as Well as for Healthy Subjects
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