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

NCT02952378 | Completed Phase 4 DMC

• 1 other identifier: VAB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• Plasma volume

  Plasma volume expansion using hemoglobin as a marker of dilution.

  5 hours

Secondary Outcomes (1)

• Colloid osmotic pressure

  5 hours

Study Arms (2)

Burn patients

EXPERIMENTAL

Patients with burns exceeding 6-8 Total Burned Surface Area %

Drug: Albumins

Healthy individuals

EXPERIMENTAL

Healthy individuals without allergies.

Drug: Albumins

Interventions

Albumins DRUG

Infusion of 3ml/kg bodyweight of hyperoncotic albumin 20% during 30 minutes.

Also known as: Albumin 20%

Burn patients; Healthy individuals

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 %

You may not qualify if:

• Heart failure
• Signs of kidney injury/failure
• Severe allergies

Sponsors & Collaborators

• University Hospital, Linkoeping: lead

Study Sites (1)

Burn ward, University Hospital, Linköping

Linköping, 58185, Sweden

Location

Related Publications (2)

• 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.

  PMID: 33350618 DERIVED

• 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.

  PMID: 32366324 DERIVED

MeSH Terms

Conditions

Burns

Interventions

Albumins; galactosamine-conjugated serum albumin-conjugated-(rhodamine X)20

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Joachim Zdolsek, MD,PhD,Assoc prof

  University Hospital, Linkoeping

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Assoc prof

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 2, 2016
• Study Start: October 1, 2016
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: May 29, 2019

Record last verified: 2019-05

Locations

SE (1)