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Volume Kinetics for Starch Solution and Acetated Ringers

16 oktober 2014 bijgewerkt door: Joachim Zdolsek, University Hospital, Linkoeping
Volume kinetics is a method mostly used, so far, to study the distribution and elimination of crystalloid solutions. Voluven (in Sweden the most commonly used colloid for replacement of bleeding during surgery) is poorly studied, though. Also, a recent study showed unexpected volume kinetics for a crystalloid solution when it was given after a colloid solution. The investigators aim to study the volume kinetics of crystalloids and colloids and also the combination of the two in more detail. The investigators will also compare the invasive hemoglobin measurements with measurements from a new non-invasive tool (Radical 7, from Masimo Inc.) which could help to make volume kinetics more practical for everyday use. Finally the investigators will also study the concentrations of a few coagulation factors to see if they can explain the variations in coagulability that has been described in earlier studies of infusion solutions.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

We will study ten volunteers, each one on three occasions. Each volunteer will receive only crystalloid one time, only colloid another time, and on the third occasion first a colloid and then a crystalloid one hour later. The different protocols will be in random order in the different volunteers. During all these tests we will sample the hemoglobin (both invasive and non-invasive) every fifth minute in the beginning (every tenth minute later) after the infusion. On six to nine occasions during each test we will analyse Albumin, Cystatin-C, Ig-G, Ig-M as markers of hemodilution and D-Dimer, Fibrinogen, Factor VII, PK-INR (prothrombin complex international normalized ratio), and aPTT (activated partial thromboplastin time) as markers of coagulation. The volunteers are also monitored regarding non-invasive blood pressure and pulse rate.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

10

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Zweden
      • Linköping, Zweden, 581 85
        • University Hospital, Intensive care unit

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 50 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Mannelijk

Beschrijving

Inclusion Criteria: healthy males between 20 and 50 years were advertised for. Males due to simplified urine collection during supine position.

Exclusion Criteria:

under age < 18 years

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: A.acetatedRingers, B.colloid & C.colloid+acetatedRingers

First intervention: A. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by 150 minutes of equilibration, when blood samples were collected.

Washout >7 days

Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.

Washout > 7 Days

Third intervention: C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.
Geneesmiddel: acetated Ringers
Infusion of Ringer acetate 20 ml/kg over 30 min
Geneesmiddel: colloid
Infusion of starch 10 ml/kg over 30 min
Andere namen:
  • Voluven
Geneesmiddel: colloid+acetated Ringer
Infusion of combined colloid+acetated Ringer; 10 ml/kg of starch was infused between 0 and 30 min, followed by 20 ml/kg of Ringers acetate between 105 and 135 min.
Andere namen:
  • Voluven
  • acetated Ringers
Apparaat: Non-invasive hemoglobin with pulse-oximeter (SpHb)
Non-invasive hemoglobin with pulse-oximeter (SpHb) was measured in all subjects, during all infusions.
Andere namen:
  • Radical 7, Masimo
Ander: A.colloid, B.colloid+acetatedRinger & C.acetatedRingers

First intervention: A. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.

Washout >7 days

Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.

Washout > 7 Days

Third intervention: C. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected.
Geneesmiddel: acetated Ringers
Infusion of Ringer acetate 20 ml/kg over 30 min
Geneesmiddel: colloid
Infusion of starch 10 ml/kg over 30 min
Andere namen:
  • Voluven
Geneesmiddel: colloid+acetated Ringer
Infusion of combined colloid+acetated Ringer; 10 ml/kg of starch was infused between 0 and 30 min, followed by 20 ml/kg of Ringers acetate between 105 and 135 min.
Andere namen:
  • Voluven
  • acetated Ringers
Apparaat: Non-invasive hemoglobin with pulse-oximeter (SpHb)
Non-invasive hemoglobin with pulse-oximeter (SpHb) was measured in all subjects, during all infusions.
Andere namen:
  • Radical 7, Masimo
Ander: A.acetatedRingers, B.acetatedRingers+colloid & C.colloid

First intervention: A. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected.

Washout >7 days

Second intervention: B.Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.

Washout > 7 Days

Third intervention: C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.
Geneesmiddel: acetated Ringers
Infusion of Ringer acetate 20 ml/kg over 30 min
Geneesmiddel: colloid
Infusion of starch 10 ml/kg over 30 min
Andere namen:
  • Voluven
Geneesmiddel: colloid+acetated Ringer
Infusion of combined colloid+acetated Ringer; 10 ml/kg of starch was infused between 0 and 30 min, followed by 20 ml/kg of Ringers acetate between 105 and 135 min.
Andere namen:
  • Voluven
  • acetated Ringers
Apparaat: Non-invasive hemoglobin with pulse-oximeter (SpHb)
Non-invasive hemoglobin with pulse-oximeter (SpHb) was measured in all subjects, during all infusions.
Andere namen:
  • Radical 7, Masimo
Ander: A.colloid, B.acetatedRingers & C.colloid+acetatedRingers

First intervention: A. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected.

Washout >7 days

Second intervention: B. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected.

Washout > 7 Days

Third intervention: C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.
Geneesmiddel: acetated Ringers
Infusion of Ringer acetate 20 ml/kg over 30 min
Geneesmiddel: colloid
Infusion of starch 10 ml/kg over 30 min
Andere namen:
  • Voluven
Geneesmiddel: colloid+acetated Ringer
Infusion of combined colloid+acetated Ringer; 10 ml/kg of starch was infused between 0 and 30 min, followed by 20 ml/kg of Ringers acetate between 105 and 135 min.
Andere namen:
  • Voluven
  • acetated Ringers
Apparaat: Non-invasive hemoglobin with pulse-oximeter (SpHb)
Non-invasive hemoglobin with pulse-oximeter (SpHb) was measured in all subjects, during all infusions.
Andere namen:
  • Radical 7, Masimo
Ander: A.colloid+acetatedRingers, B.colloid & C.acetated Ringers

First intervention: A. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.

Washout >7 days

Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.

Washout > 7 Days

Third intervention: C. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected.
Geneesmiddel: acetated Ringers
Infusion of Ringer acetate 20 ml/kg over 30 min
Geneesmiddel: colloid
Infusion of starch 10 ml/kg over 30 min
Andere namen:
  • Voluven
Geneesmiddel: colloid+acetated Ringer
Infusion of combined colloid+acetated Ringer; 10 ml/kg of starch was infused between 0 and 30 min, followed by 20 ml/kg of Ringers acetate between 105 and 135 min.
Andere namen:
  • Voluven
  • acetated Ringers
Apparaat: Non-invasive hemoglobin with pulse-oximeter (SpHb)
Non-invasive hemoglobin with pulse-oximeter (SpHb) was measured in all subjects, during all infusions.
Andere namen:
  • Radical 7, Masimo

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Volume Effects for Hydroxyethyl Starch, Ringer's Solution or a Combination of Both.
Tijdsspanne: 420 minutes

volume kinetics: mathematical calculation from hemoglobin variations during and after an infusion.

Degree of plasma dilution depending on which solution(s) and how much solution is/are given.
420 minutes
Elimination Half Life for Different Fluids Alone or When Combined
Tijdsspanne: 420 minutes
Volume kinetic analyses of the dilution of hemoglobin for different infusion fluids alone or in combination.
420 minutes

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Accuracy of Non-invasive Hemoglobin Monitoring for Different Fluids
Tijdsspanne: 420 min

Pulse-oximeter based measurements compared with invasive hemoglobin measurements. All paired in the study.

Accuracy depending on which infusion is selected (Ringer's, Hydroxyethyl starch or a combination of both).
420 min
Accuracy of Noninvasive Haemoglobin Measurement by Pulse Oximetry, for Different Fluids (Start to End of Infusion)
Tijdsspanne: 30 min

Difference between true hemoglobin B-Hb and measured hemoglobin with pulseoximeter (SpHb)at the end of an infusion in relation to the initial measured values SpHb and B-Hb at the start of the infusion.

Relative difference (%) = (SpHb - Hb)/((Hb+SpHb)/2) x 100
30 min
Variation of Coagulation Factors and Plasma Proteins During and After Infusion of Crystalloid and Colloid Solutions.
Tijdsspanne: 420 minutes
The investigators will measure a few markers of coagulation (fibrinogen, thrombocytes, D-Dimer, PK-INR, aPTT, and coagulation factor VII) as well as Cystatin C, serum albumine and hemoglobin and how the concentration of these vary with the different dilutions of blood during and after infusion of a colloid and/or a crystalloid solution.
420 minutes

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Linkoeping

Onderzoekers

  • Hoofdonderzoeker: Joachim Zdolsek, MD, PhD, University Hospital, Linköping, Sweden

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 augustus 2010

Primaire voltooiing (Werkelijk)

1 mei 2011

Studie voltooiing (Werkelijk)

1 mei 2011

Studieregistratiedata

Eerst ingediend

31 augustus 2010

Eerst ingediend dat voldeed aan de QC-criteria

2 september 2010

Eerst geplaatst (Schatting)

3 september 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

22 oktober 2014

Laatste update ingediend die voldeed aan QC-criteria

16 oktober 2014

Laatst geverifieerd

1 oktober 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • VkVR

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