Infusion Rate and Volume Kinetics for Hyperoncotic Albumine in Healthy Subjects ((RAV))
Treatment with colloidal solutions has during long time been a cornerstone within intensive care. Lately there has been a shift from synthetic colloids to natural albumine.
One of these solutions is the hyperoncotic "Albumin 20%". There are however still several aspects of the physiological effects of hyperoncotic albumin, that are not known.
In this study the main object is to study with what rate hyperoncotic albumin should be administered. Rapidly 30 minutes or slower 120 minutes.
Studieoversigt
Detaljeret beskrivelse
Difference in volume expansion as well as fluid recruitment from the tissues depending on infusion rate is of interest.
Plasma volume expansion is measured using hemoglobin as a marker and fluid recruitment of tissue fluid is measured as a combination of plasma volume expansion and urinary output.
Healthy individuals are asked to refrain from eating and drinking the night before the study. Two hours before study start, the subjects may take a sandwich and a glas to drink.
After 15 minutes of rest baseline blood samples are taken. Subjects are randomised to receive two rates of albumin solution (Albumin 20%) 3 ml/kg bodyweight at two separate occasions. Once with an infusion time of 30 minutes, once with an infusion time of 120 minutes. Between the two infusions there will be an interval of 3 to 20 weeks. Randomization is performed to chose which rate the subjects start with. 6 in each Group (total 12).
During each occasion15 blood samples are collected, during a 6 hour period. Hemoglobin, plasma Sodium, colloid osmotic pressure and albumin are analysed. The total volume of blood collected will be 170 ml at each occasion when an albumin infusion is given.
Urinary output is measured and Urinary Sodium content is measured. Liberal fluid intake is recommended the same day and the next.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Linköping, Sverige
- Intensive Care Unit, University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Healthy, without allergies and with the age 18 years or above
Exclusion Criteria:
- Heart failure
- Signs of kidney injury/failure
- Severe allergies
- Pregnancy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Rapid - Slow
Two infusions of 3 ml/kg bodyweight of hyperoncotic albumin 20%, with an interval of 3 to 20 weeks between. First time rapid (30 minutes), second time slow (120 minutes). Albumin solution |
Infusion rate and effects
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Eksperimentel: Slow - Rapid
Two infusions of 3 ml/kg bodyweight of hyperoncotic albumin 20%, with an interval of 3 to 20 weeks between. First time rapid (120 minutes), second time slow (30 minutes). Albumin solution |
Infusion rate and effects
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Plasma volume
Tidsramme: 6 hours
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Albumin infusion expands the plasma volume and dilutes hemoglobin.
The dilution of hemoglobin can be measured and is used to calculate the degree of plasma expansion.
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6 hours
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Colloid osmotic pressure
Tidsramme: 6 hours
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Infusion of hyperoncotic albumin increases the colloid osmotic pressure of plasma.
Fluid recruitment from the tissues however diminishes the increase of the colloid osmotic pressure.
This effect is measured.
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6 hours
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Fluid recruitment from tissues
Tidsramme: 6 hours
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The recruitment of fluid from the tissues due to the increase of colloid osmotic pressure is measured.
The total recruitment of fluid from the tissues is the sum of the plasma volume dilution and urinary excretion.
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6 hours
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Joachim Zdolsek, MD, PhD,Assoc prof, University Hospital, Linkoeping
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- RAV
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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