Continuous Versus Bolus Norepinephrine Administration to Treat Postinduction Hypotension (INDUCT-Multi)

Continuous Versus Bolus Norepinephrine Administration to Treat Postinduction Hypotension in High-Risk Non-Cardiac Surgery Patients - The Multicenter INDUCT Trial (INDUCT-Multi)

INDUCT-Multi is a multicenter randomized trial investigating whether continuous, compared to bolus, administration of norepinephrine during induction of general anesthesia reduces postinduction hypotension in high-risk non-cardiac surgery patients.

Study Overview

• Status: Recruiting
• Conditions: Postinduction Hypotension
• Intervention / Treatment: Procedure: Continuous Norepinephrine Administration

Detailed Description

Hypotension after induction of general anesthesia, referred to as postinduction hypotension, is common in patients having non-cardiac surgery and is associated with acute kidney injury. Risk factors for postinduction hypotension include older age, higher American Society of Anesthesiologists physical status, chronic arterial hypertension - and higher doses of vasodilating anesthetic drugs. It is reasonable to assume that careful anesthetic management can help maintain blood pressure stability and limit postinduction hypotension. Consistent with this assumption, continuous blood pressure monitoring with an arterial catheter during induction of general anesthesia helps clinicians reduce postinduction hypotension - and is thus recommended in non-cardiac surgery patients at risk for hypotension-related complications.

Besides continuous monitoring, anesthesiologists routinely give vasopressors - such as norepinephrine - to maintain blood pressure. Norepinephrine is a fast acting vasopressor with a short half-life and is usually given as repeated manual boluses during induction of general anesthesia. Given as a bolus, it effectively and rapidly increases blood pressure. However, boluses need to be frequently repeated and well-timed to ensure blood pressure stability.

In a single-center randomized trial, we demonstrated that continuous - compared to bolus - administration of norepinephrine during induction of general anesthesia helps maintain blood pressure stability in high-risk non cardiac surgery patients. We now aim to test the hypothesis that continuous - compared to bolus - administration of norepinephrine during induction of general anesthesia reduces postinduction hypotension in high-risk non-cardiac surgery patients who have continuous blood pressure monitoring with an arterial catheter.

• Study Type: Interventional
• Enrollment (Estimated): 446
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen K Thomsen, MD; Phone Number: +4940741070215; Email: kr.thomsen@uke.de

Study Locations

• Germany
  • Düsseldorf, Germany
    • Not yet recruiting
    • Department of Anesthesiology, University Hospital Duesseldorf, Heinrich Heine University Duesseldorf
    • Contact: Sebastian Roth, MD; Phone Number: +49 211 81 16253; Email: Sebastian.Roth@med.uni-duesseldorf.de
  • Giessen, Germany
    • Not yet recruiting
    • Department of Anaesthesiology, Intensive Care Medicine and Pain Medicine, University Hospital Giessen, Justus-Liebig University Giessen
    • Contact: Michael Sander, MD; Phone Number: +49 641 / 985-44401; Email: Michael.Sander@chiru.med.uni-giessen.de
  • Hamburg, Germany
    • Not yet recruiting
    • Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf
    • Contact: Kristen K Thomsen, MD; Phone Number: +4940741070215; Email: kr.thomsen@uke.de
  • München, Germany
    • Recruiting
    • Department of Anaesthesiology, University Hospital LMU Munich
    • Contact: Agnes Meidert, MD; Phone Number: +49 89 440081065; Email: Agnes.meidert@med.uni-muenchen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

We will include consenting patients ≥45 years scheduled for elective major non-cardiac surgery under general anesthesia with planned continuous intra-arterial blood pressure monitoring with a radial arterial catheter and with at least two of the following risk criteria for developing acute kidney injury:

• Age ≥65 years
• ASA physical status III or IV
• Chronic arterial hypertension
• Diabetes mellitus requiring medication
• Intra-abdominal surgery
• Preoperative renal insufficiency (serum creatinine ≥1.2 mg/dL)

Exclusion Criteria:

• Pregnancy
• Cardiac arrhythmia
• History of intracranial hemorrhage or intracranial aneurysm
• Clinical indication for continuous norepinephrine infusion during induction of general anesthesia (e.g., severe aortic valve stenosis, coronary artery disease, or heart failure)
• Patients who are unable to understand, read, and provide informed consent in German

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous Norepinephrine Administration; In patients assigned to continuous norepinephrine administration, norepinephrine will be administered continuously via a syringe infusion pump.	Procedure: Continuous Norepinephrine Administration; In patients assigned to continuous administration of norepinephrine, a syringe infusion pump will be prepared and connected to a peripheral or central venous catheter. The responsible anesthesiologist will start the norepinephrine infusion and adjust the infusion rate as necessary and may administer additional norepinephrine boluses via the syringe infusion pump if required.
No Intervention: Bolus Norepinephrine Administration; In patients assigned to manual bolus norepinephrine administration, norepinephrine will be given manually in bolus doses.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under a MAP of 60 mmHg (mmHg x min)	First 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)	First 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)	First 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)	First 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)	First 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)	First 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)	First 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)	First 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)	First 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)	First 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)	First 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)	First 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)	First 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)	First 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)	First 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	First 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	First 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	First 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	First 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	First 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	First 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	First 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	First 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	First 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	First 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	First 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	First 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	First 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	First 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	First 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	First 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)	First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.

Other Outcome Measures

Outcome Measure	Time Frame
Acute kidney injury	Within the first 3 postoperative days
Nonfatal cardiac arrest	Within the first 3 postoperative days
Myocardial infarction	Within the first 3 postoperative days
Death	Within the first 3 postoperative days

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: norepinephrine; hypotension; non-cardiac surgery; continuous; postinduction hypotension; bolus
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension
• Other Study ID Numbers: 2025-101645-BO-ff

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No