Effect off infusion rate of hyperoncotic albumin and koncentration off albumin on fluid balance in the body

Infusion rate and volumekinetics for hyperoncotic albumin in healthy subjects (RAV), - A phase IV, randomized, open-labeled, cross-over study - RAV

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003687-12-SE

Enrollment

Registered

2017-09-22

Start date

2017-11-22

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 Fluid mobilisation.

Interventions

Trade Name: Albunorm 200 g/l Product Name: Human albumin Pharmaceutical Form: Solution for infusion Trade Name: Albunorm 50 mg/ml Produ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy volunteers 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 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. > 60 år 2. Anamsticaly known decreased kidney function 3. Hypotensive problems, such as a feeling of dizzyness when rizing up to quickly. 4. Hypertension (systolic blood pressure >150 and diastolic blood pressure > 95) 5. Allergic reaction to albumin infusion. 6. Taking part in a clinicak trial within 30 Days previously. 7. Pregnancy, which is tested with Urin-hcg. 8. Dementia or problems to understand instructions.

Design outcomes

Primary

Measure	Time frame
Main Objective: To study if infusion rate of intravenous administered hyperoncotic albumin is relavant for attraction of fluid from the interstitium and to compare this effect with isooncotic albumin.; Secondary Objective: Does the infusion rate of hyperoncotic albumin effect the duration of the hyperoncotic induced plasma dilution? Is there a difference when comparing with an equivivalent dose isooncotic albumin? ;Primary end point(s): Difference in fluid recruitment from the tissues depending on infusion rate of hyperoncotic albumine (a combination on blood volume expansion and urinary output).;Timepoint(s) of evaluation of this end point: Six hours after start of infusion. The effects of the infusion rates are compared after the end of the study.	—

Measure

Time frame

Main Objective: To study if infusion rate of intravenous administered hyperoncotic albumin is relavant for attraction of fluid from the interstitium and to compare this effect with isooncotic albumin.; Secondary Objective: Does the infusion rate of hyperoncotic albumin effect the duration of the hyperoncotic induced plasma dilution? Is there a difference when comparing with an equivivalent dose isooncotic albumin? ;Primary end point(s): Difference in fluid recruitment from the tissues depending on infusion rate of hyperoncotic albumine (a combination on blood volume expansion and urinary output).;Timepoint(s) of evaluation of this end point: Six hours after start of infusion. The effects of the infusion rates are compared after the end of the study.

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: At the end of the study 6 hours after start of infusion.; Secondary end point(s): 1. What is the maximum blood volume expansion with the two different infusion rates? 2. Bloodvolume expansion over time? 3. From where is the fluid recruited? 4. Albumine leakage depending on infusion rate. 5. What happens with the glycocalyx of the endothelium depending on infusion rate ? 6. Is there a difference compared to isooncotic solution	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: At the end of the study 6 hours after start of infusion.; Secondary end point(s): 1. What is the maximum blood volume expansion with the two different infusion rates? 2. Bloodvolume expansion over time? 3. From where is the fluid recruited? 4. Albumine leakage depending on infusion rate. 5. What happens with the glycocalyx of the endothelium depending on infusion rate ? 6. Is there a difference compared to isooncotic solution

—

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 11, 2026