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Kontinuerlig versus bolus noradrenalinadministration til behandling af postinduktionshypotension (INDUCT-Multi)

1. juni 2026 opdateret af: Kristen Thomsen, Universitätsklinikum Hamburg-Eppendorf

Kontinuerlig versus bolus-administration af norepinefrin til behandling af postinduktionshypotension hos højrisiko-patienter i ikke-hjertekirurgi - Det multicentriske INDUCT-forsøg (INDUCT-Multi)

INDUCT-Multi er et multicentrisk randomiseret forsøg, der undersøger, om kontinuerlig, i forhold til bolus, administration af norepinefrin under induktion af generel anæstesi reducerer postinduktionshypotension hos højrisiko ikke-hjertekirurgiske patienter.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Hypotension efter induktion af generel anæstesi, kendt som postinduktionshypotension, er almindelig hos patienter, der gennemgår ikke-hjertekirurgi, og er forbundet med akut nyreskade. Risikofaktorer for postinduktionshypotension inkluderer højere alder, højere fysisk status ifølge American Society of Anesthesiologists, kronisk arteriel hypertension - og højere doser af vasodilaterende anæstesimedicin. Det er rimeligt at antage, at omhyggelig anæstesistyring kan hjælpe med at opretholde blodtryksstabilitet og begrænse postinduktionshypotension. I overensstemmelse med denne antagelse hjælper kontinuerlig blodtryksovervågning med en arteriekateter under induktion af generel anæstesi klinikere med at reducere postinduktionshypotension - og anbefales derfor hos ikke-hjertekirurgiske patienter med risiko for hypotensionsrelaterede komplikationer.

Udover kontinuerlig overvågning giver anæstesilæger rutinemæssigt vasopressorer - såsom norepinefrin - for at opretholde blodtrykket. Norepinefrin er en hurtigtvirkende vasopressor med en kort halveringstid og gives normalt som gentagne manuelle bolusdoser under induktion af generel anæstesi. Givet som en bolus øger det effektivt og hurtigt blodtrykket. Dog skal bolusdoser gentages hyppigt og være vel-timet for at sikre blodtryksstabilitet.

I et randomiseret forsøg på et enkelt center har vi vist, at kontinuerlig - sammenlignet med bolus - administration af norepinefrin under induktion af generel anæstesi hjælper med at opretholde blodtryksstabilitet hos højrisiko ikke-hjertekirurgiske patienter. Vi har nu til formål at teste hypotesen om, at kontinuerlig - sammenlignet med bolus - administration af norepinefrin under induktion af generel anæstesi reducerer postinduktionshypotension hos højrisiko ikke-hjertekirurgiske patienter, der har kontinuerlig blodtryksovervågning med en arteriekateter.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

446

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

  • Navn: Kristen K Thomsen, MD
  • Telefonnummer: +4940741070215
  • E-mail: kr.thomsen@uke.de

Studiesteder

  • Tyskland
      • Düsseldorf, Tyskland
        • Rekruttering
        • Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University Duesseldorf
        • Kontakt:
      • Giessen, Tyskland
        • Ikke rekrutterer endnu
        • Department of Anaesthesiology, Intensive Care Medicine and Pain Medicine, University Hospital Giessen, Justus-Liebig University Giessen
        • Kontakt:
      • Hamburg, Tyskland
        • Ikke rekrutterer endnu
        • Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
        • Kontakt:
      • München, Tyskland
        • Rekruttering
        • Department of Anaesthesiology, University Hospital LMU Munich
        • Kontakt:

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

Vi vil inkludere samtykkende patienter ≥45 år, planlagt til elektiv større ikke-hjertekirurgi under generel anæstesi med planlagt kontinuerlig intra-arteriel blodtryksovervågning med en radial arteriekateter og med mindst to af følgende risikokriterier for udvikling af akut nyreskade:

  • Alder ≥65 år
  • ASA fysisk status III eller IV
  • Kronisk arteriel hypertension
  • Diabetes mellitus, der kræver medicin
  • Intra-abdominal kirurgi
  • Præoperativ nyreinsufficiens (serumkreatinin ≥1,2 mg/dL)

Eksklusionskriterier:

  • Graviditet
  • Hjertearytmi
  • Tidligere intrakraniel blødning eller intrakranielt aneurisme
  • Klinisk indikation for kontinuerlig norepinefrin infusion under induktion af generel anæstesi (f.eks. svær aortaklapsstenose, koronararteriesygdom eller hjertesvigt)
  • Patienter, der ikke er i stand til at forstå, læse og give informeret samtykke på tysk

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Kontinuerlig Noradrenalinadministration
Hos patienter tildelt kontinuerlig norepinefrin-administration, vil norepinefrin blive administreret kontinuerligt via en sprøjteinfusionspumpe.
Procedure: Kontinuerlig Norepinefrin-administration
Hos patienter, der er tildelt kontinuerlig administration af norepinefrin, vil en sprøjteinfusionspumpe blive forberedt og tilsluttet en perifer eller central venekateter. Den ansvarlige anæstesiolog vil starte norepinefrin-infusionen og justere infusionshastigheden efter behov og kan administrere yderligere norepinefrin-bolus via sprøjteinfusionspumpen, hvis det er nødvendigt.
Ingen indgriben: Bolus Norepinefrin Administration
Hos patienter, der er tildelt manuel bolusnorepinefrinadministration, gives norepinefrin manuelt i bolusdoser.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Area under a mean arterial pressure (MAP) of 65 mmHg (mmHg x min)
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.

Sekundære resultatmål

Resultatmål
Tidsramme
Area under a MAP of 60 mmHg (mmHg x min)
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Area under a MAP of 50 mmHg (mmHg x min)
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Area under a MAP of 40 mmHg (mmHg x min)
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Area above a MAP of 100 mmHg (mmHg x min)
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Area above a MAP of 110 mmHg (mmHg x min)
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Area above a MAP of 120 mmHg (mmHg x min)
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Area above a MAP of 140 mmHg (mmHg x min)
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Duration of a MAP <65 mmHg (min)
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Duration of a MAP <60 mmHg (min)
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Duration of a MAP <50 mmHg (min)
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Duration of a MAP <40 mmHg (min)
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Duration of a MAP >100 mmHg (min)
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Duration of a MAP >110 mmHg (min)
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Duration of a MAP >120 mmHg (min)
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Duration of a MAP >140 mmHg (min)
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Absolute (n) and relative (%) number of patients with any MAP measurement <65 mmHg
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Absolute (n) and relative (%) number of patients with any MAP measurement <60 mmHg
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Absolute (n) and relative (%) number of patients with any MAP measurement <50 mmHg
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Absolute (n) and relative (%) number of patients with any MAP measurement <40 mmHg
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Absolute (n) and relative (%) number of patients with any MAP measurement >100 mmHg
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Absolute (n) and relative (%) number of patients with any MAP measurement >110 mmHg
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Absolute (n) and relative (%) number of patients with any MAP measurement >120 mmHg
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Absolute (n) and relative (%) number of patients with any MAP measurement >140 mmHg
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <65 mmHg
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <60 mmHg
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <50 mmHg
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <40 mmHg
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >100 mmHg
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >110 mmHg
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >120 mmHg
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >140 mmHg
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
Cumulative dose of norepinephrine indexed to body weight (µg kg-1)
Tidsramme: First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.

Andre resultatmål

Resultatmål
Tidsramme
Acute kidney injury
Tidsramme: Within the first 3 postoperative days
Within the first 3 postoperative days
Nonfatal cardiac arrest
Tidsramme: Within the first 3 postoperative days
Within the first 3 postoperative days
Myocardial infarction
Tidsramme: Within the first 3 postoperative days
Within the first 3 postoperative days
Death
Tidsramme: Within the first 3 postoperative days
Within the first 3 postoperative days

Samarbejdspartnere og efterforskere

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

Sponsor

Universitätsklinikum Hamburg-Eppendorf

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)

7. maj 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

31. marts 2026

Først indsendt, der opfyldte QC-kriterier

15. april 2026

Først opslået (Faktiske)

20. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025-101645-BO-ff

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Postinduktion hypotension

Kliniske forsøg med Kontinuerlig Norepinefrin-administration

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