Volume Kinetics for 20% Albumin in Different Clinical Situations
NCT ID: NCT02556580
Last Updated: 2018-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
45 participants
INTERVENTIONAL
2016-02-29
2019-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Conscious healthy volunteers
Intervention: intravenious infusion Drug: albumin 20%
Albumin 20%
Intervention: intravenious infusion Drug: albumin
Surgery under general anesthesia
Intervention: intravenious infusion Drug: albumin 20%
Albumin 20%
Intervention: intravenious infusion Drug: albumin
Post-surgical inflammation
Intervention: intravenious infusion Drug: albumin 20%
Albumin 20%
Intervention: intravenious infusion Drug: albumin
Interventions
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Albumin 20%
Intervention: intravenious infusion Drug: albumin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients in ASA classes I-II scheduled for surgery.
Exclusion Criteria
* Blood hemoglobin concentration of \< 10 g/dL.
18 Years
ALL
Yes
Sponsors
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University Hospital, Linkoeping
OTHER
Karolinska University Hospital
OTHER
Sodertalje Hospital
OTHER
Responsible Party
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Robert Hahn
Research Dircetor
Principal Investigators
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Robert G Hahn, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Research Director, Södertälje sjukhus
Locations
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Linköping University Hospital
Linköping, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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Hedin A, Hahn RG. Volume expansion and plasma protein clearance during intravenous infusion of 5% albumin and autologous plasma. Clin Sci (Lond). 2005 Mar;108(3):217-24. doi: 10.1042/CS20040303.
Woodcock TM, Woodcock TE. Revised Starling equation predicts pulmonary edema formation during fluid loading in the critically ill with presumed hypovolemia. Crit Care Med. 2012 Sep;40(9):2741-2; author reply 2742. doi: 10.1097/CCM.0b013e31825ae6c9. No abstract available.
Wiedermann CJ, Dunzendorfer S, Gaioni LU, Zaraca F, Joannidis M. Hyperoncotic colloids and acute kidney injury: a meta-analysis of randomized trials. Crit Care. 2010;14(5):R191. doi: 10.1186/cc9308. Epub 2010 Oct 28.
Gunnstrom M, Zdolsek JH, Hahn RG. Plasma Volume Expansion and Fluid Kinetics of 20% Albumin During General Anesthesia and Surgery Lasting for More Than 5 Hours. Anesth Analg. 2022 Jun 1;134(6):1270-1279. doi: 10.1213/ANE.0000000000005802. Epub 2021 Nov 18.
Other Identifiers
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Albumin April 2015
Identifier Type: -
Identifier Source: org_study_id
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