Kontinuerlig jämfört med bolusadministration av norepinefrin för behandling av postinduktionshypotension (INDUCT-Multi)
24 juni 2026 uppdaterad av: Kristen Thomsen, Universitätsklinikum Hamburg-Eppendorf
Kontinuerlig kontra bolusadministrering av norepinefrin för behandling av postinduktionshypotension hos högriskpatienter inom icke-hjärtkirurgi – Det multcentriska INDUCT-försöket (INDUCT-Multi)
INDUCT-Multi är ett multicenter randomiserat försök som undersöker om kontinuerlig, jämfört med bolus, administrering av norepinefrin under induktion av allmän anestesi minskar postinduktionshypotension hos högriskpatienter för icke-hjärtkirurgi.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Hypotension efter induktion av allmän anestesi, även kallad postinduktionshypotension, är vanligt hos patienter som genomgår icke-hjärtkirurgi och är förknippat med akut njurskada. Riskfaktorer för postinduktionshypotension inkluderar högre ålder, högre American Society of Anesthesiologists fysisk status, kronisk arteriell hypertoni - och högre doser av vasodilaterande anestesimedel. Det är rimligt att anta att noggrann anestesihantering kan hjälpa till att upprätthålla blodtrycksstabilitet och begränsa postinduktionshypotension. I enlighet med detta antagande hjälper kontinuerlig blodtrycksövervakning med en artärkateter under induktion av allmän anestesi kliniker att minska postinduktionshypotension - och rekommenderas därför för icke-hjärtkirurgiska patienter med risk för hypotensionsrelaterade komplikationer.
Förutom kontinuerlig övervakning ger anestesiologer rutinmässigt vasopressorer - som norepinefrin - för att upprätthålla blodtryck. Norepinefrin är en snabbt verkande vasopressor med kort halveringstid och ges vanligtvis som upprepade manuella bolusdoseringar under induktion av allmän anestesi. Given som bolus ökar det effektivt och snabbt blodtrycket. Emellertid behöver bolusdoseringar ofta upprepas och vara väl tajmade för att säkerställa blodtrycksstabilitet.
I en randomiserad encentrumsstudie visade vi att kontinuerlig - jämfört med bolus - administration av norepinefrin under induktion av allmän anestesi hjälper till att upprätthålla blodtrycksstabilitet hos högriskpatienter för icke-hjärtkirurgi. Vi syftar nu till att testa hypotesen att kontinuerlig - jämfört med bolus - administration av norepinefrin under induktion av allmän anestesi minskar postinduktionshypotension hos högriskpatienter för icke-hjärtkirurgi som har kontinuerlig blodtrycksövervakning med en artärkateter.
Studietyp
Interventionell
Inskrivning (Beräknad)
446
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Kristen K Thomsen, MD
- Telefonnummer: +4940741070215
- E-post: kr.thomsen@uke.de
Studieorter
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Berlin, Tyskland
- Har inte rekryterat ännu
- Department of Anesthesiology and Intensive Care Medicine, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
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Kontakt:
- Sascha Treskatsch, MD
- Telefonnummer: +49 30 450 551 522
- E-post: sascha.treskatsch@charite.de
-
Düsseldorf, Tyskland
- Rekrytering
- Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University Duesseldorf
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Kontakt:
- Sebastian Roth, MD
- Telefonnummer: +49 211 81 16253
- E-post: Sebastian.Roth@med.uni-duesseldorf.de
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Hamburg, Tyskland
- Rekrytering
- Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
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Kontakt:
- Kristen K Thomsen, MD
- Telefonnummer: +4940741070215
- E-post: kr.thomsen@uke.de
-
München, Tyskland
- Rekrytering
- Department of Anaesthesiology, University Hospital LMU Munich
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Kontakt:
- Agnes Meidert, MD
- Telefonnummer: +49 89 440081065
- E-post: Agnes.meidert@med.uni-muenchen.de
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inklusionskriterier:
Vi kommer att inkludera samtyckande patienter ≥45 år som är planerade för elektiv större icke-hjärtkirurgi under generell anestesi med planerad kontinuerlig intraarteriell blodtrycksövervakning med en radial artärkateter och med minst två av följande riskkriterier för att utveckla akut njurskada:
- Ålder ≥65 år
- ASA fysisk status III eller IV
- Kronisk arteriell hypertoni
- Diabetes mellitus som kräver medicinering
- Intraabdominell kirurgi
- Preoperativ njurinsufficiens (serumkreatinin ≥1,2 mg/dL)
Exklusionskriterier:
- Graviditet
- Hjärtarytmi
- Anamnes med intrakraniell blödning eller intrakraniellt aneurysm
- Klinisk indikation för kontinuerlig noradrenalininfusion under induktion av generell anestesi (t.ex. svår aortaklaffstenos, kranskärlssjukdom eller hjärtsvikt)
- Patienter som inte kan förstå, läsa och ge informerat samtycke på tyska
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Kontinuerlig Noradrenalinadministrering
Hos patienter som tilldelats kontinuerlig noradrenalinadministration kommer noradrenalin att administreras kontinuerligt via en sprutinfusionspump.
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Hos patienter som tilldelats kontinuerlig administration av norepinefrin kommer en sprutinfusionspump att förberedas och anslutas till en perifer eller central venkateter.
Den ansvariga anestesiläkaren kommer att starta norepinefrininfusionen och justera infusionshastigheten efter behov och kan administrera ytterligare norepinefrinbolusar via sprutinfusionspumpen om det behövs.
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Inget ingripande: Bolusadministrering av Norepinefrin
Hos patienter som tilldelats manuell bolusadministration av norepinefrin kommer norepinefrin att ges manuellt i bolusdos.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Area under a mean arterial pressure (MAP) of 65 mmHg (mmHg x min)
Tidsram: 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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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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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Area under a MAP of 60 mmHg (mmHg x min)
Tidsram: 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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Area under a MAP of 50 mmHg (mmHg x min)
Tidsram: 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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|
Area under a MAP of 40 mmHg (mmHg x min)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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.
|
Andra resultatmått
Resultatmått |
Tidsram |
|---|---|
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Acute kidney injury
Tidsram: Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
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Nonfatal cardiac arrest
Tidsram: Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
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Myocardial infarction
Tidsram: Within the first 3 postoperative days
|
Within the first 3 postoperative days
|
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Death
Tidsram: Within the first 3 postoperative days
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Within the first 3 postoperative days
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
7 maj 2026
Primärt slutförande (Beräknad)
1 december 2026
Avslutad studie (Beräknad)
1 december 2026
Studieregistreringsdatum
Först inskickad
31 mars 2026
Först inskickad som uppfyllde QC-kriterierna
15 april 2026
Första postat (Faktisk)
20 april 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025-101645-BO-ff
Plan för individuella deltagardata (IPD)
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