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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02952378
Acronym
VAB
Enrollment
30
Registered
2016-11-02
Start date
2016-10-31
Completion date
2019-01-31
Last updated
2019-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

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.

Interventions

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

Sponsors

University Hospital, Linkoeping
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Plasma volume5 hoursPlasma volume expansion using hemoglobin as a marker of dilution.

Secondary

MeasureTime frameDescription
Colloid osmotic pressure5 hoursEffect of hyperoncotic albumin on oncotic pressure.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026