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

NCT ID: NCT02952378

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-01-31

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.

Conditions

Burns

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Burn patients

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

Group Type: EXPERIMENTAL

Albumins

Intervention Type: DRUG

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

Healthy individuals

Healthy individuals without allergies.

Group Type: EXPERIMENTAL

Albumins

Intervention Type: DRUG

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

Interventions

Albumins

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

Intervention Type: DRUG

Other Intervention Names

Albumin 20%

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Linkoeping

OTHER

Sponsor Role: lead

Responsible Party

Joachim Zdolsek

MD, PhD, Assoc prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joachim Zdolsek, MD,PhD,Assoc prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Linkoeping

Locations

Burn ward, University Hospital, Linköping

Linköping, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 33350618 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32366324 (View on PubMed)

Other Identifiers

VAB

Identifier Type: -

Identifier Source: org_study_id