Avoiding Postinduction Hypotension: the Clinical ZERO-HYPOTENSION Proof-of-concept Study

Not Applicable

Completed

• Conditions: Anesthesia; Hypotension on Induction; Hypotension
• Interventions: Procedure: Monitoring; Procedure: Norepinephrine preparation; Procedure: Propofol administration; Procedure: Alarm adjustment; Procedure: Intervention threshold

• Registration Number: NCT05842759
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Study First Submitted: 2023-03-05
• Study Start: 2023-03-07
• Study First Submitted QC: 2023-04-22
• Study First Posted: 2023-05-06
• Primary Completion: 2023-08-07
• Study Completion: 2023-08-07
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypotension Avoidance Strategy	Norepinephrine preparation	After the patients' arrival in the induction area, routine anesthetic monitoring (electrocardiography and pulse oximetry) will be established. In all patients, the arterial catheter for continuous intraarterial blood pressure monitoring will be inserted before anesthetic induction (after the insertion site has been infiltrated with a local anesthetic). An uncalibrated pulse wave analysis monitor (MostCareUP, Vygon, Aachen, Germany) will be connected to the patient monitor for advanced hemodynamic monitoring of including cardiac output, systemic vascular resistance, stroke volume variation, and pulse pressure variation. Besides continuous intraarterial blood pressure monitoring, the hypotension avoidance strategy will be applied.
Hypotension Avoidance Strategy	Propofol administration	After the patients' arrival in the induction area, routine anesthetic monitoring (electrocardiography and pulse oximetry) will be established. In all patients, the arterial catheter for continuous intraarterial blood pressure monitoring will be inserted before anesthetic induction (after the insertion site has been infiltrated with a local anesthetic). An uncalibrated pulse wave analysis monitor (MostCareUP, Vygon, Aachen, Germany) will be connected to the patient monitor for advanced hemodynamic monitoring of including cardiac output, systemic vascular resistance, stroke volume variation, and pulse pressure variation. Besides continuous intraarterial blood pressure monitoring, the hypotension avoidance strategy will be applied.
Hypotension Avoidance Strategy	Monitoring	After the patients' arrival in the induction area, routine anesthetic monitoring (electrocardiography and pulse oximetry) will be established. In all patients, the arterial catheter for continuous intraarterial blood pressure monitoring will be inserted before anesthetic induction (after the insertion site has been infiltrated with a local anesthetic). An uncalibrated pulse wave analysis monitor (MostCareUP, Vygon, Aachen, Germany) will be connected to the patient monitor for advanced hemodynamic monitoring of including cardiac output, systemic vascular resistance, stroke volume variation, and pulse pressure variation. Besides continuous intraarterial blood pressure monitoring, the hypotension avoidance strategy will be applied.
Hypotension Avoidance Strategy	Alarm adjustment	After the patients' arrival in the induction area, routine anesthetic monitoring (electrocardiography and pulse oximetry) will be established. In all patients, the arterial catheter for continuous intraarterial blood pressure monitoring will be inserted before anesthetic induction (after the insertion site has been infiltrated with a local anesthetic). An uncalibrated pulse wave analysis monitor (MostCareUP, Vygon, Aachen, Germany) will be connected to the patient monitor for advanced hemodynamic monitoring of including cardiac output, systemic vascular resistance, stroke volume variation, and pulse pressure variation. Besides continuous intraarterial blood pressure monitoring, the hypotension avoidance strategy will be applied.
Hypotension Avoidance Strategy	Intervention threshold	After the patients' arrival in the induction area, routine anesthetic monitoring (electrocardiography and pulse oximetry) will be established. In all patients, the arterial catheter for continuous intraarterial blood pressure monitoring will be inserted before anesthetic induction (after the insertion site has been infiltrated with a local anesthetic). An uncalibrated pulse wave analysis monitor (MostCareUP, Vygon, Aachen, Germany) will be connected to the patient monitor for advanced hemodynamic monitoring of including cardiac output, systemic vascular resistance, stroke volume variation, and pulse pressure variation. Besides continuous intraarterial blood pressure monitoring, the hypotension avoidance strategy will be applied.

Primary Outcome Measures

Name	Time	Method
Area under a MAP of 65 mmHg	First 15 minutes of induction of general anesthesia	Area under a mean arterial pressure (MAP) of 65 mmHg within the first 15 minutes of anesthetic induction \[mmHg x min\].

Secondary Outcome Measures

Name	Time	Method
Area under threshold	First 15 minutes of induction of general anesthesia	Area under a MAP of 60, 50, and 40 mmHg \[mmHg x min\]
1-minute Hypotension	First 15 minutes of induction of general anesthesia	Absolute \[n\] and relative \[%\] number of patients with at least one 1-minute episode of a MAP \<65, \<60, \<50, and \<40 mmHg
Area above the curve	First 15 minutes of induction of general anesthesia	Area above a MAP of 100, 110, 120, 140 mmHg \[mmHg x min\]
Duration	First 15 minutes of induction of general anesthesia	Duration of MAP \<65, \<60, \<50, and \<40 mmHg \[min\]
Any Hypotension	First 15 minutes of induction of general anesthesia	Absolute \[n\] and relative \[%\] number of patients with any MAP measurement \<65, \<60, \<50, and \<40 mmHg
Norepinephrine	First 15 minutes of induction of general anesthesia	Cumulative dose of norepinephrine indexed to body weight \[μg kg-1\]

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany