The ability of strong albumin solution infused intravenously to allocate fluid from the tissues to the cirkulation in healthy subjects and in burn patients

Volumekinetics for hyperoncotic albumin in burn patients as well as for healthy subjects. - VAB (Volumekintics of Albumin in Burn patients)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000996-26-SE

Enrollment

Registered

2016-04-13

Start date

2016-09-01

Completion date

Unknown

Last updated

2019-04-30

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

Conditions

Healthy adult volunteers and burn patients 3 to 10 Days after the injury.

Interventions

Trade Name: Albumin 20% Product Name: Human albumin Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy volunteers Burn patients 3 to 10 Days after the injury. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with serious cardiac or pulmonary disease. Health stats corresponding to American Society of Anesthesiologists (ASA) Group III and IV. Inability to understand instructions. Dementia.

Design outcomes

Primary

Measure	Time frame
Main Objective: To study if intravenously administered hyperoncotic albumin can attract fluid from the interstitium to the cirkulation in healthy individuals and in burn patients.; Secondary Objective: Half-life of plasma volume expansion. Plasma half-life of infused albumin ;Primary end point(s): The data Collection is completed 4 hours after the 30-min infusion of albumin is initiated.;Timepoint(s) of evaluation of this end point: The study Always ends 4 hours after start of infusion.	—

Measure

Time frame

Main Objective: To study if intravenously administered hyperoncotic albumin can attract fluid from the interstitium to the cirkulation in healthy individuals and in burn patients.; Secondary Objective: Half-life of plasma volume expansion. Plasma half-life of infused albumin ;Primary end point(s): The data Collection is completed 4 hours after the 30-min infusion of albumin is initiated.;Timepoint(s) of evaluation of this end point: The study Always ends 4 hours after start of infusion.

—

Secondary

Measure	Time frame
Secondary end point(s): Collection of data for calculation of the duration of plasma volume expansion and the plasma half-life of albumin is ended at 4 hours after the infusion starts.;Timepoint(s) of evaluation of this end point: At the end of the study 4 hours after infusion start.	—

Countries

Sweden

Contacts

Public ContactBurn Unit

Region Ostergotland

joachim.zdolsek@regionostergotland.se+46101031154

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 27, 2026