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Væskeudfordring og plasmavolumen under kirurgi (FC-VE)

9. november 2026 opdateret af: Joachim Zdolsek

Sammenligning af albumin og Ringers løsning til optimering af plasmavolumen og hæmodynamik under laparoskopisk kirurgi.

A short bolus infusion of fluid, called "fluid challenge" is commonly recommended for fluid treatment during longer surgery. However a prolonged increase of the blood volume is a prerequisite to recommend the technique. The purpose with the study is to examine the plasma expanding effect of three different fluid challenge strategies (acetated Ringers 4 ml/kg body weight, albumin 5% 4 ml/kg body weight or albumin 20% 1 ml/kg body weight), using hemoglobin as a dilution indicator.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

60 patients scheduled for laparoscopic abdominal surgery, with a duration exceeding 90 minutes will be included in the study. These are randomized to three different groups (20 in each groups): The first group of patients will receive boluses of acetated Ringers 4 ml/kg body weight. The second albumin 4 ml/kg body weight and the third group albumin 20% 1 ml/kg body weight.

Hemoglobin, albumin and colloid osmotic pressure (COP) is sampled the day before surgery and in the morning directly prior to the anesthesia. Bioimpedance, urine osmolality and urine-creatinin are also measured. After induction of surgery a Cardio Q probe is inserted threw the nose into the esophagus, for circulatory measurements. Initial/baseline blood samples are taken after insufflation of carbon dioxide to the abdomen. Before every bolus of fluid and 5, (10), 15, 20, 30, 40, (50) and (60) minutes new blood samples are taken for determination of hemoglobin, albumin and COP. Artery blood gases are sampled 15 minutes after every infusion or depending on the clinical need.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

65

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sverige
    • Östergötland County
      • Norrköping, Östergötland County, Sverige, 60379
        • Vrinnevi Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Written consent to participate in the study
  • For women: relevant contraceptive, menopausal or a negative pregnancy test.
  • ASA category I to III
  • Laparoscopic abdominal surgery, with a duration of at least 90 minutes.
  • 18 to 85 years

Exclusion Criteria:

  • Patients with known cardiac failure
  • <18 or >85 years
  • known allergy to albumin
  • extracellular hyperhydration or hypervolemia
  • kidney failure
  • pregnancy or planned pregnancy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: acetated Ringers

The circulatory effect of a bolus infusion with 4 ml/kg body weight of acetated Ringers will be studied. If cardiac output increase with 10% a second bolus will be infused and further studied.
Medicin: acetated Ringers

After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first fluid bolus is infused. Circulatory and volume effects are studied. If cardiac output increase a second bolus is infused and studied.

Andre navne:
  • Ringers acetat
  • ringer acetat
  • acetat Ringer´s
Eksperimentel: albumin 5%

The circulatory effect of a bolus infusion with 4 ml/kg body weight of Albumin 5% will be studied. If cardiac output increases with 10% a second bolus will be infused and further studied.
Medicin: albumin 5%

After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first bolus of fluid is infused. Circulatory and volume effects are studied. If cardiac output increases a second bolus is infused and studied.

Andre navne:
  • Humant albumin 5 %
  • Albumin (menneske) 5 %
Eksperimentel: albumin 20%

The circulatory effect of a bolus infusion with 1 ml/kg body weight of Albumin 20% will be studied. If cardiac output increase with 10% a second bolus will be infused and further studied.
Medicin: albumin 20%

After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first bolus of fluid is infused. Circulatory and volume effects are studied. If cardiac output increases a second bolus is infused and studied.

Andre navne:
  • Humant albumin 20 %
  • Albumin (menneske) 20 %

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Plasma volume expansion after a fluid bolus
Tidsramme: 60 minutes after an intravenous fluid bolus

Plasma volume using hemoglobin as an indicator of dilution
60 minutes after an intravenous fluid bolus

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fluid Balance
Tidsramme: 18 to 24 hours

Calculations of fluid balance
18 to 24 hours
Stroke Volume
Tidsramme: 60 minutes after an intravenous fluid bolus

Change in stroke volume, measured with Cardio Q (oesophageal Doppler monitoring (ODM))
60 minutes after an intravenous fluid bolus
Arterial Blood Pressure
Tidsramme: 60 minutes after an intravenous fluid bolus

Mean Arterial Pressure, measured with an arterial line.
60 minutes after an intravenous fluid bolus
Heart Rate
Tidsramme: 60 minutes after an intravenous fluid bolus

Heart rate, measured with ECG and pulseoximeter.
60 minutes after an intravenous fluid bolus
Bioimpedance
Tidsramme: 18 to 24 hours

Bioimpedance measures, resistance and impedance converted to volume of body fluid compartments.
18 to 24 hours
Serum Creatinin
Tidsramme: 18 to 24 hours

Serum Creatinin as a measure of kidney function
18 to 24 hours
arterial pH
Tidsramme: 60 minutes after an intravenous fluid bolus

Influence of a fluid bolus on arterial blood gases
60 minutes after an intravenous fluid bolus
arterial Base Excess
Tidsramme: 60 minutes after an intravenous fluid bolus

Influence of a fluid bolus on arterial blood gases
60 minutes after an intravenous fluid bolus
arterial serum sodium
Tidsramme: 60 minutes after an intravenous fluid bolus

Influence of a fluid bolus on Sodium concentration
60 minutes after an intravenous fluid bolus
arterial serum chloride
Tidsramme: 60 minutes after an intravenous fluid bolus

Influence of a fluid bolus on Chloride concentrations
60 minutes after an intravenous fluid bolus

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Joachim Zdolsek

Efterforskere

  • Ledende efterforsker: Joachim Zdolsek, MD PhD, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. oktober 2023

Primær færdiggørelse (Faktiske)

10. juni 2026

Studieafslutning (Faktiske)

10. juni 2026

Datoer for studieregistrering

Først indsendt

15. januar 2023

Først indsendt, der opfyldte QC-kriterier

9. februar 2023

Først opslået (Faktiske)

13. februar 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FC-VE

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual de-identified results will be shared, when results are published.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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