Kontinuerlig versus bolus noradrenalin administrering for behandling av postinduksjons hypotensjon (INDUCT-Multi)
24. juni 2026 oppdatert av: Kristen Thomsen, Universitätsklinikum Hamburg-Eppendorf
Kontinuerlig versus bolus norepinefrin-administrasjon for behandling av postinduksjonshypotensjon hos høyrisiko ikke-hjertekirurgiske pasienter - Den multisinsenter INDUCT-studien (INDUCT-Multi)
INDUCT-Multi er et multicenter, randomisert studie som undersøker om kontinuerlig, sammenlignet med bolus, administrering av norepinefrin under induksjon av generell anestesi reduserer postinduksjonshypotensi hos høyt risikopasienter i ikke-hjertekirurgi.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Hypotensjon etter induksjon av generell anestesi, referert til som postinduksjonshypotensjon, er vanlig hos pasienter som gjennomgår ikke-hjertekirurgi og er assosiert med akutt nyreskade. Risikofaktorer for postinduksjonshypotensjon inkluderer høyere alder, høyere fysisk status i henhold til American Society of Anesthesiologists, kronisk arteriell hypertensjon - og høyere doser av vasodilaterende anestetiske legemidler. Det er rimelig å anta at forsiktig anestesibehandling kan bidra til å opprettholde blodtrykksstabilitet og begrense postinduksjonshypotensjon. I tråd med denne antakelsen hjelper kontinuerlig blodtrykksovervåking med en arteriekateter under induksjon av generell anestesi klinikere med å redusere postinduksjonshypotensjon - og anbefales derfor for ikke-hjertekirurgiske pasienter i risiko for hypotensjonsrelaterte komplikasjoner.
I tillegg til kontinuerlig overvåking, gir anestesileger rutinemessig vasopressorer - som norepinefrin - for å opprettholde blodtrykket. Norepinefrin er en rasktverkende vasopressor med kort halveringstid og gis vanligvis som gjentatte manuelle bolusdoser under induksjon av generell anestesi. Gitt som bolus, øker det effektivt og raskt blodtrykket. Imidlertid må bolusdoser gjentas ofte og være godt tidsbestemt for å sikre blodtrykksstabilitet.
I en enkelt-senter randomisert studie viste vi at kontinuerlig - sammenlignet med bolus - administrering av norepinefrin under induksjon av generell anestesi hjelper til med å opprettholde blodtrykksstabilitet hos høyt risikable ikke-hjertekirurgiske pasienter. Vi har nå som mål å teste hypotesen om at kontinuerlig - sammenlignet med bolus - administrering av norepinefrin under induksjon av generell anestesi reduserer postinduksjonshypotensjon hos høyt risikable ikke-hjertekirurgiske pasienter som har kontinuerlig blodtrykksovervåking med en arteriekateter.
Studietype
Intervensjonell
Registrering (Antatt)
446
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Kristen K Thomsen, MD
- Telefonnummer: +4940741070215
- E-post: kr.thomsen@uke.de
Studiesteder
-
-
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Berlin, Tyskland
- Har ikke rekruttert ennå
- Department of Anesthesiology and Intensive Care Medicine, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
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Ta kontakt med:
- Sascha Treskatsch, MD
- Telefonnummer: +49 30 450 551 522
- E-post: sascha.treskatsch@charite.de
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Düsseldorf, Tyskland
- Rekruttering
- Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University Duesseldorf
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Ta kontakt med:
- Sebastian Roth, MD
- Telefonnummer: +49 211 81 16253
- E-post: Sebastian.Roth@med.uni-duesseldorf.de
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Hamburg, Tyskland
- Rekruttering
- Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
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Ta kontakt med:
- Kristen K Thomsen, MD
- Telefonnummer: +4940741070215
- E-post: kr.thomsen@uke.de
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München, Tyskland
- Rekruttering
- Department of Anaesthesiology, University Hospital LMU Munich
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Ta kontakt med:
- Agnes Meidert, MD
- Telefonnummer: +49 89 440081065
- E-post: Agnes.meidert@med.uni-muenchen.de
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
Vi vil inkludere samtykkende pasienter ≥45 år planlagt for elektiv stor ikke-hjertekirurgi under generell anestesi med planlagt kontinuerlig intraarteriell blodtrykksovervåkning med en radial arteriekater og med minst to av følgende risikokriterier for utvikling av akutt nyreskade:
- Alder ≥65 år
- ASA fysisk status III eller IV
- Kronisk arteriell hypertensjon
- Diabetes mellitus som krever medikamentell behandling
- Intra-abdominal kirurgi
- Preoperativ nyreinsuffisiens (serumkreatinin ≥1,2 mg/dL)
Eksklusjonskriterier:
- Svangerskap
- Hjertearytmi
- Tidligere intrakranielt blødning eller intrakranielt aneurisme
- Klinisk indikasjon for kontinuerlig norepinefrininfusjon under innledning av generell anestesi (f.eks. alvorlig aortaklaffstenose, koronararteriesykdom eller hjertesvikt)
- Pasienter som ikke er i stand til å forstå, lese og gi informert samtykke på tysk
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Kontinuerlig administrering av norepinefrin
Hos pasienter som er tildelt kontinuerlig administrering av norepinefrin, vil norepinefrin administreres kontinuerlig via en sprøyteinfusjonspumpe.
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Hos pasienter som er tildelt kontinuerlig administrering av norepinefrin, vil en sprøytepumpe tilberedes og tilkobles en perifer eller sentral venekateter.
Den ansvarlige anestesilegen vil starte norepinefrininfusjonen og justere infusjonshastigheten etter behov og kan gi tilleggsdoser av norepinefrin via sprøytepumpen om nødvendig.
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Ingen inngripen: Bolus Noradrenalinadministrering
Hos pasienter tildelt manuell bolus-administrasjon av norepinefrin, vil norepinefrin gis manuelt i bolusdoser.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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.
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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
|
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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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
7. mai 2026
Primær fullføring (Antatt)
1. desember 2026
Studiet fullført (Antatt)
1. desember 2026
Datoer for studieregistrering
Først innsendt
31. mars 2026
Først innsendt som oppfylte QC-kriteriene
15. april 2026
Først lagt ut (Faktiske)
20. april 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025-101645-BO-ff
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