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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05842759
• Other study ID #: 2022-100896-BO-ff
• Status: Completed
• Phase: N/A
• Start date: March 7, 2023
• Est. completion date: August 7, 2023

Study information

• Verified date: September 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 7, 2023
• Est. primary completion date: August 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Hypotension
• Hypotension on Induction

Intervention

Procedure:
• Monitoring
Continuous blood pressure monitoring
• Norepinephrine preparation
Norepinephrine infusion will be prepared and connected to peripheral or central venous catheter (infusion will not be started)
• Propofol administration
Propofol infusion will be started only when clinical effects of opioid are noticeable: 1.5 mg/kg propofol in patients less than 55 years old and 1.0 mg/kg propofol in patients 55 years or older over 90 seconds
• Alarm adjustment
Lower mean arterial pressure alarm threshold will be set to 75 mmHg
• Intervention threshold
Lower mean arterial pressure intervention threshold will be 75 mmHg: continuous norepinephrine infusion will be started when mean arterial blood decreases below 75 mmHg

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiac Output/Index (Exploratory Endpoint)	Descriptive analysis including minimum value, duration under threshold, area under threshold, absolute and relative number of patients with at least one episode under threshold.	First 15 minutes of induction of general anesthesia
Other	Stroke Volume/Index (Exploratory Endpoint)	Descriptive analysis including minimum value, duration under threshold, area under threshold, absolute and relative number of patients with at least one episode under threshold.	First 15 minutes of induction of general anesthesia
Other	dP/dt (Exploratory Endpoint)	Descriptive analysis including minimum value, duration under threshold, area under threshold, absolute and relative number of patients with at least one episode under threshold.	First 15 minutes of induction of general anesthesia
Other	Eadyn (Exploratory Endpoint)	Descriptive analysis including minimum value, duration under threshold, area under threshold, absolute and relative number of patients with at least one episode under threshold.	First 15 minutes of induction of general anesthesia
Other	Stroke volume variation (Exploratory Endpoint)	Descriptive analysis including minimum value, duration under threshold, area under threshold, absolute and relative number of patients with at least one episode under threshold.	First 15 minutes of induction of general anesthesia
Other	Pulse pressure variation (Exploratory Endpoint)	Descriptive analysis including minimum value, duration under threshold, area under threshold, absolute and relative number of patients with at least one episode under threshold.	First 15 minutes of induction of general anesthesia
Other	Systemic vascular resistance (Exploratory Endpoint)	Descriptive analysis including minimum value, duration under threshold, area under threshold, absolute and relative number of patients with at least one episode under threshold.	First 15 minutes of induction of general anesthesia
Primary	Area under a MAP of 65 mmHg	Area under a mean arterial pressure (MAP) of 65 mmHg within the first 15 minutes of anesthetic induction [mmHg x min].	First 15 minutes of induction of general anesthesia
Secondary	Area under threshold	Area under a MAP of 60, 50, and 40 mmHg [mmHg x min]	First 15 minutes of induction of general anesthesia
Secondary	Duration	Duration of MAP <65, <60, <50, and <40 mmHg [min]	First 15 minutes of induction of general anesthesia
Secondary	Any Hypotension	Absolute [n] and relative [%] number of patients with any MAP measurement <65, <60, <50, and <40 mmHg	First 15 minutes of induction of general anesthesia
Secondary	1-minute Hypotension	Absolute [n] and relative [%] number of patients with at least one 1-minute episode of a MAP <65, <60, <50, and <40 mmHg	First 15 minutes of induction of general anesthesia
Secondary	Area above the curve	Area above a MAP of 100, 110, 120, 140 mmHg [mmHg x min]	First 15 minutes of induction of general anesthesia
Secondary	Norepinephrine	Cumulative dose of norepinephrine indexed to body weight [µg kg-1]	First 15 minutes of induction of general anesthesia