Continuous Versus Bolus Norepinephrine Administration to Treat Postinduction Hypotension

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorUniversitätsklinikum Hamburg-Eppendorf

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥65 years

ASA physical status III or IV

Chronic arterial hypertension

Diabetes mellitus requiring medication

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Continuous Norepinephrine Administration

    Procedure/Surgery

    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.

Treatment groups

446 Participants
are divided into 2 treatment groups
Group A: Continuous Norepinephrine AdministrationExperimental treatment 1 intervention
Group B: Bolus Norepinephrine AdministrationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Area under a mean arterial pressure (MAP) of 65 mmHg (mmHg x min)

Time frame
First 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 outcomes

1

Area under a MAP of 60 mmHg (mmHg x min)

Time frame
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
2

Area under a MAP of 50 mmHg (mmHg x min)

Time frame
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
3

Area under a MAP of 40 mmHg (mmHg x min)

Time frame
First 15 minutes after starting induction of general anesthesia. The start of anesthetic induction is defined as the administration of propofol as hypnotic induction agent.
4

Area above a MAP of 100 mmHg (mmHg x min)

Time frame
First 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 outcomes

1

Acute kidney injury

Time frame
Within the first 3 postoperative days
2

Nonfatal cardiac arrest

Time frame
Within the first 3 postoperative days
3

Myocardial infarction

Time frame
Within the first 3 postoperative days
4

Death

Time frame
Within the first 3 postoperative days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.