Clinical trial NCT05842759: Avoiding Postinduction Hypotension: the Clinical ZERO-HYPOTENSION Proof-of-concept Study
Official title: Avoiding Postinduction Hypotension: the Clinical ZERO-HYPOTENSION Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Anesthesia
Hypotension on Induction
Keywords: Hypotension
Low Blood Pressure
Anesthesia Induction
Surgery
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, single center, clinical interventional proof-of-concept study in 120 patients scheduled for elective major non-cardiac surgery at the University Medical Center Hamburg-Eppendorf.
Primary purpose: TREATMENT

Brief summary: In this clinical proof-of-concept study, the aim is to investigate the efficacy of a hypotension avoidance strategy to prevent post-induction hypotension. Specifically, it will be investigate how much postinduction hypotension occurs when using a hypotension avoidance strategy - combining continuous intraarterial blood pressure monitoring, careful administration of anesthetic drugs, and continuous administration of norepinephrine to treat hypotension - in high-risk patients having elective non-cardiac surgery.

Detailed description: Hypotension is common in patients having non-cardiac surgery with general anesthesia and is associated with organ injury. About one third of hypotension occurs "postinduction" - i.e., after the induction of general anesthesia but before surgical incision. Unmodifiable risk factors for postinduction hypotension include age, male sex, and a high American Society of Anesthesiologists physical status. However, postinduction hypotension is mainly driven by modifiable factors - specifically, anesthetic drugs that cause vasodilation. Vasodilation can be effectively treated with vasopressors, e.g. norepinephrine.

It is reasonable to assume that postinduction hypotension is largely avoidable by careful anesthetic and hemodynamic monitoring and management during anesthetic induction. A hypotension avoidance strategy could include continuous intraarterial blood pressure monitoring, careful administration of anesthetic drugs, and continuous administration of norepinephrine to treat hypotension. However, it remains unknown to which extent a hypotension avoidance strategy actually can avoid postinduction hypotension. Before testing the effectiveness of hypotension avoidance strategies in large-scale randomized trials it is important to investigate their efficacy.

In this clinical proof-of-concept study, the aim is to investigate the efficacy of a hypotension avoidance strategy to prevent post-induction hypotension. Specifically, it will be investigate how much postinduction hypotension occurs when using a hypotension avoidance strategy - combining continuous intraarterial blood pressure monitoring, careful administration of anesthetic drugs, and continuous administration of norepinephrine to treat hypotension - in high-risk patients having elective non-cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status classification III or higher, and in whom intraarterial blood pressure monitoring is planned for clinical indication

Exclusion Criteria:

* Emergency surgery
* Transplant surgery
* History of organ transplant
* Sepsis
* Pregnancy
* Contraindications for the use of propofol
* Rapid sequence induction

Primary outcomes:
measure: Area under a MAP of 65 mmHg
timeFrame: First 15 minutes of induction of general anesthesia
Secondary outcomes:
measure: Area under threshold
timeFrame: First 15 minutes of induction of general anesthesia
measure: Duration
timeFrame: First 15 minutes of induction of general anesthesia
measure: Any Hypotension
timeFrame: First 15 minutes of induction of general anesthesia
measure: 1-minute Hypotension
timeFrame: First 15 minutes of induction of general anesthesia
measure: Area above the curve
timeFrame: First 15 minutes of induction of general anesthesia
measure: Norepinephrine
timeFrame: First 15 minutes of induction of general anesthesia
Other outcomes:
measure: Cardiac Output/Index (Exploratory Endpoint)
timeFrame: First 15 minutes of induction of general anesthesia
measure: Stroke Volume/Index (Exploratory Endpoint)
timeFrame: First 15 minutes of induction of general anesthesia
measure: dP/dt (Exploratory Endpoint)
timeFrame: First 15 minutes of induction of general anesthesia
measure: Eadyn (Exploratory Endpoint)
timeFrame: First 15 minutes of induction of general anesthesia
measure: Stroke volume variation (Exploratory Endpoint)
timeFrame: First 15 minutes of induction of general anesthesia
measure: Pulse pressure variation (Exploratory Endpoint)
timeFrame: First 15 minutes of induction of general anesthesia
measure: Systemic vascular resistance (Exploratory Endpoint)
timeFrame: First 15 minutes of induction of general anesthesia
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Moritz Flick
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Kristen Thomsen
role: PRINCIPAL_INVESTIGATOR
References: