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Continuele versus bolus toediening van norepinefrine voor de behandeling van postinductie hypotensie (INDUCT-Multi)

24 juni 2026 bijgewerkt door: Kristen Thomsen, Universitätsklinikum Hamburg-Eppendorf

Continuele Versus Bolus Noradrenaline Toediening voor de Behandeling van Postinductie Hypotensie bij Hoogrisico Niet-Cardiale Chirurgiepatiënten - De Multicenter INDUCT Studie (INDUCT-Multi)

INDUCT-Multi is een multicenter gerandomiseerde studie die onderzoekt of continue, vergeleken met bolus, toediening van norepinefrine tijdens inductie van algehele anesthesie postinductie hypotensie vermindert bij hoogrisico niet-cardiale chirurgiepatiënten.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Hypotensie na inductie van algemene anesthesie, ook wel postinductiehypotensie genoemd, komt vaak voor bij patiënten die niet-cardiale chirurgie ondergaan en wordt geassocieerd met acuut nierletsel. Risicofactoren voor postinductiehypotensie zijn onder meer hogere leeftijd, een hogere American Society of Anesthesiologists fysieke status, chronische arteriële hypertensie - en hogere doses vaatverwijdende anesthetica. Het is redelijk om aan te nemen dat zorgvuldige anesthesiologische behandeling kan helpen de bloeddrukstabiliteit te behouden en postinductiehypotensie te beperken. In overeenstemming met deze aanname helpt continue bloeddrukmonitoring met een arteriële katheter tijdens inductie van algemene anesthesie clinici om postinductiehypotensie te verminderen - en wordt daarom aanbevolen bij niet-cardiale chirurgiepatiënten met risico op hypotensiegerelateerde complicaties.

Naast continue monitoring geven anesthesiologen routinematig vasopressoren - zoals norepinefrine - om de bloeddruk te handhaven. Norepinefrine is een snelwerkende vasopressor met een korte halfwaardetijd en wordt meestal toegediend als herhaalde handmatige bolussen tijdens inductie van algemene anesthesie. Als bolus toegediend, verhoogt het de bloeddruk effectief en snel. Echter, bolussen moeten vaak worden herhaald en goed getimed zijn om bloeddrukstabiliteit te garanderen.

In een gerandomiseerde trial in één centrum hebben we aangetoond dat continue - vergeleken met bolus - toediening van norepinefrine tijdens inductie van algemene anesthesie helpt de bloeddrukstabiliteit te behouden bij hoogrisico niet-cardiale chirurgiepatiënten. We willen nu de hypothese testen dat continue - vergeleken met bolus - toediening van norepinefrine tijdens inductie van algemene anesthesie postinductiehypotensie vermindert bij hoogrisico niet-cardiale chirurgiepatiënten die continue bloeddrukmonitoring met een arteriële katheter hebben.

Studietype

Ingrijpend

Inschrijving (Geschat)

446

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

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

Studie Locaties

  • Duitsland
      • Berlin, Duitsland
        • Nog niet aan het werven
        • Department of Anesthesiology and Intensive Care Medicine, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
        • Contact:
      • Düsseldorf, Duitsland
        • Werving
        • Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University Duesseldorf
        • Contact:
      • Hamburg, Duitsland
        • Werving
        • Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
        • Contact:
      • München, Duitsland
        • Werving
        • Department of Anaesthesiology, University Hospital LMU Munich
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusiecriteria:

We zullen instemmende patiënten ≥45 jaar oud opnemen die gepland staan voor electieve grote niet-cardiale chirurgie onder algehele anesthesie met geplande continue intra-arteriële bloeddrukmonitoring met een radiale arteriële katheter en met ten minste twee van de volgende risicocriteria voor het ontwikkelen van acute nierinsufficiëntie:

  • Leeftijd ≥65 jaar
  • ASA fysieke status III of IV
  • Chronische arteriële hypertensie
  • Diabetes mellitus die medicatie vereist
  • Intra-abdominale chirurgie
  • Preoperatieve nierinsufficiëntie (serumcreatinine ≥1,2 mg/dL)

Exclusiecriteria:

  • Zwangerschap
  • Cardiale aritmie
  • Geschiedenis van intracraniële bloeding of intracranieel aneurysma
  • Klinische indicatie voor continue noradrenaline-infusie tijdens inductie van algehele anesthesie (bijv. ernstige aortaklepstenose, coronaire hartziekte of hartfalen)
  • Patiënten die niet in staat zijn om in het Duits geïnformeerde toestemming te begrijpen, te lezen en te verlenen

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Continue toediening van norepinefrine
Bij patiënten die zijn toegewezen aan continue norepinefrine-toediening, wordt norepinefrine continu toegediend via een spuitinfuuspomp.
Procedure: Continuele Norepinefrine Toediening
Bij patiënten die zijn toegewezen aan continue toediening van norepinefrine, wordt een spuitinfuuspomp voorbereid en aangesloten op een perifere of centrale veneuze katheter. De verantwoordelijke anesthesioloog start de norepinefrine-infusie en past de infusiesnelheid indien nodig aan en kan indien nodig aanvullende norepinefrine-bolussen toedienen via de spuitinfuuspomp.
Geen tussenkomst: Bolus Norepinefrine Toediening
Bij patiënten die zijn toegewezen aan handmatige bolustoediening van norepinefrine, wordt norepinefrine handmatig toegediend in bolusdoseringen.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Area under a mean arterial pressure (MAP) of 65 mmHg (mmHg x min)
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Area under a MAP of 60 mmHg (mmHg x min)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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.

Andere uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 mei 2026

Primaire voltooiing (Geschat)

1 december 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

31 maart 2026

Eerst ingediend dat voldeed aan de QC-criteria

15 april 2026

Eerst geplaatst (Werkelijk)

20 april 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

24 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2025-101645-BO-ff

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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