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Volume Kinetics for 20% Albumin in Different Clinical Situations

Volume Kinetics for 20% Albumin in Conscious and Anesthetized Humans With and Without Inflammation

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02556580
Acronym
Albumin
Enrollment
45
Registered
2015-09-22
Start date
2016-02-29
Completion date
2019-04-01
Last updated
2018-03-20

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

Conditions

Unconscious, Inflammation

Keywords

albumin, surgery, inflammation, volume kinetics

Brief summary

The study aims to determine the degree of plasma volume expansion and the half-life of the plasma volume expansion when 3 mL/kg of hyperoncotic (20%) albumin if infused over 30 minutes in conscious healthy volunteers, in patients undergoing surgery under general anesthesia, and on the day after major surgery when the patient is in a post surgical inflammatory state. The study also examines the increase in the plasma colloid osmotic pressure as a result of this infusion and its possible influence on markers of kidney damage.

Detailed description

15 volunteers, 15 patients undergoing surgery and 15 patients in the post-surgical phase will be recruited for this study because they have different degrees of vasodilatation and inflammation, which are factors of potential importance to the effectiveness of plasma volume expansion with albumin 20%. Hyperoncotic albumin should logically recruit fluid from the interstitial fluid space, but this possibility has recently been questioned in the revised Starling equation. The degree of plasma volume expansion and also the half-life will be estimated by population volume kinetics which uses serial analyses of the blood hemoglobin concentration and a summary measure of the excreted urine during the 5-hour experiment to calculate these outcome measures. There is a risk that hyperoncotic solutions cause pre-renal anuria due to the rise in plasma oncotic pressure. As a safety measure we will assess the plasma oncotic pressure and relevant biomarkers of renal function during the experiments. The experiments will be ended with a slow infusion of 1 L of Ringer´s acetate to dilute any raised oncotic pressure.

Interventions

Intervention: intravenious infusion Drug: albumin

Sponsors

University Hospital, Linkoeping
CollaboratorOTHER
Karolinska University Hospital
CollaboratorOTHER
Sodertalje Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Healthy volunteers. * Patients in ASA classes I-II scheduled for surgery.

Exclusion criteria

* Expected major hemorrhage during surgery. * Blood hemoglobin concentration of \< 10 g/dL.

Design outcomes

Primary

MeasureTime frameDescription
Degree of plasma volume expansion5 hoursCalculated by volume kinetics

Secondary

MeasureTime frameDescription
Increase in plasma oncotic pressure5 hoursMeasured by oncometer
Possible effect on biomarkers of kidney injury5 hoursUrinary albumin excretion (unit: mmol of albumin per mmol of urinary creatinine) and urinary neutrophil gelatinase-associated lipocalin (NGAL) excretion (unit: µg/L per mmol of creatinine).
Half-life of plasma volume expansion5 hoursCalculated from the restoration of the diluted blood hemoglobnin concentration

Countries

Sweden

Contacts

Primary ContactRobert G Hahn, MD, PhD
robert.hahn@sll.se0046 8 55024000
Backup ContactJoachim Zdolsek, MD, PhD
joachim.zdolsek@regionostergotland.se00456 70 3031434

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026