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Fluid Management in Patients Undergoing Cardiac Surgery (Hemacetat)

2. november 2017 opdateret af: University Hospital Inselspital, Berne

Fluid Management in Patients Undergoing Cardiac Surgery - Effects of an Acetate Versus Lactate Buffered Balanced Infusion Solution on Hemodynamic Stability, a Randomized Controlled Double-blind Trial

Background: Currently used crystalloid solutes have a variable composition and may therefore influence acid-base status, intra- and extracellular water content and plasma electrolyte compositions and have a major impact on organ function and outcome. Despite continuing evaluation no superiority of one particular type of fluid has been reached so far. To the best of the investigators' knowledge no study in humans has ever assessed whether the type of crystalloid fluid given for fluid resuscitation in patients undergoing cardiac surgery has an impact on hemodynamic stability and cardiac function so far. Nonetheless in the animal model it was shown that the choice of crystalloid fluid may greatly influence cardiac performance

Primary Aim: In this study the investigators want to clarify whether a balanced type acetate-buffered fluid solution in patients undergoing cardiac surgery is associated with better hemodynamic stability and cardiac function than a lactate-buffered crystalloid solute.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

150

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Schweiz
      • Bern, Schweiz, 3010
        • Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Elective single heart valve replacement
  • Elective double valve replacement
  • Elective single or double valve replacement and coronary artery bypass grafting

Exclusion Criteria:

  • Patients unable to give informed consent
  • Patients younger than 18 years of age or older than 80 years
  • Pregnancy or breastfeeding
  • Ejection fraction (EF) of less than 30% preoperatively
  • Preexisting renal insufficiency with a glomerular filtration rate below 30ml/min
  • Patients transferred form the intensive care unit to the operating theater
  • Emergency operation
  • Reoperation
  • Patients planned for fast-track surgery
  • Patients planned for minimal extracorporal circuits
  • Preexisting anemia requiring immediate perioperative blood transfusion
  • Chronic inflammatory diseases
  • Any signs of infection or sepsis
  • Limitation of full therapy (e.g. Jehowa's witnesses)

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Ringer lactate
Fluid resuscitation will be performed with lactated Ringers during the perioperative period. Perioperative hemodynamic management will be performed according to a specified treatment protocol.
Procedure: perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect)
Perioperative hemodynamic management will be performed according to a specified treatment protocol.
Aktiv komparator: Ringer acetate
Fluid resuscitation will be performed with acetated Ringers during the perioperative period. Perioperative hemodynamic management will be performed according to a specified treatment protocol.
Procedure: perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect)
Perioperative hemodynamic management will be performed according to a specified treatment protocol.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Cumulative dose of inopressors (norepinephrine and epinephrine) per kg bodyweight/hour during the perioperative period
Tidsramme: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))

Sekundære resultatmål

Resultatmål
Tidsramme
Time on inopressors
Tidsramme: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Cumulative dose of inodilators
Tidsramme: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Time on inodilators
Tidsramme: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Cumulative dose of vasodilatators
Tidsramme: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Time on vasodilatators
Tidsramme: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Total amount of fluid
Tidsramme: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Changes in acid-base status
Tidsramme: Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))
Perioperative period (induction of anesthesia until extubation in the intensive care unit, usually less than 24 hours))

Samarbejdspartnere og efterforskere

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

Sponsor

University Hospital Inselspital, Berne

Efterforskere

  • Ledende efterforsker: Carmen A Pfortmueller, MD, Department of Intensive Care, Bern University Hospital and University of Bern, Bern, Switzerland

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

1. december 2016

Primær færdiggørelse (Faktiske)

19. oktober 2017

Studieafslutning (Faktiske)

19. oktober 2017

Datoer for studieregistrering

Først indsendt

30. august 2016

Først indsendt, der opfyldte QC-kriterier

5. september 2016

Først opslået (Skøn)

12. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2017

Sidst verificeret

1. november 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20160804.1.3

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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