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The ability of strong albumin solution infused intravenously to allocate fluid from the interstitial fluid space in situations relevant to healthcare.

Volume kinetics for 20% albumin in conscious and anaesthetized humans with and without inflammation.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-001135-20-SE
Enrollment
Unknown
Registered
2015-03-12
Start date
2015-04-28
Completion date
Unknown
Last updated
2015-07-10

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

Conditions

Healthy adult volunteers, healthy patients undergoing surgery under general anesthesia, and patients in a state of inflammation after having undergone surgery under general anaesthesia (within 24 hrs after the end of the surgery).

Interventions

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

Sponsors

Södertälje sjukhus AB
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy volunteers. Healthy patients undergoing lengthy surgery with expected small hemorrhage. Patients scheduled for lengthy surgery who have inflammatory disease with expected small hemorrhage. 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 45 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 Anesthersiologists (ASA) Group III and IV. Inability to understand Swedish. Dementia.

Design outcomes

Primary

MeasureTime frame
Main Objective: To study if hyperoncotic albumin can attract interstitial fluid under three circumstances - conscious, anesthetized state, and anesthetized state in patients with inflammation. ;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 is always ended at 4 hours.—

Secondary

MeasureTime frame
Secondary end point(s): Collection of data for calculation of the duration of the plasma volume expansion and the plasma half-life of albumin is also 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 the infusion was initiated.—

Countries

Sweden

Contacts

Public ContactRobert Hahn

Södertälje sjukhus AB

robert.hahn@sodertaljesjukhus.se46855024670

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026