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

NCT05842759 | Completed

• 1 other identifier: 2022-100896-BO-ff
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension; Anesthesia; Hypotension on Induction

Keywords

Hypotension; Low Blood Pressure; Anesthesia Induction; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Area under threshold

  First 15 minutes of induction of general anesthesia

• Duration

  First 15 minutes of induction of general anesthesia

• Any Hypotension

  First 15 minutes of induction of general anesthesia

• 1-minute Hypotension

  First 15 minutes of induction of general anesthesia

• Area above the curve

  First 15 minutes of induction of general anesthesia

Other Outcomes (7)

• Cardiac Output/Index (Exploratory Endpoint)

  First 15 minutes of induction of general anesthesia

• Stroke Volume/Index (Exploratory Endpoint)

  First 15 minutes of induction of general anesthesia

• dP/dt (Exploratory Endpoint)

  First 15 minutes of induction of general anesthesia

Study Arms (1)

Hypotension Avoidance Strategy

OTHER

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.

Procedure: Monitoring; Procedure: Norepinephrine preparation; Procedure: Propofol administration; Procedure: Alarm adjustment; Procedure: Intervention threshold

Interventions

Monitoring PROCEDURE

Continuous blood pressure monitoring

Hypotension Avoidance Strategy

Norepinephrine preparation PROCEDURE

Norepinephrine infusion will be prepared and connected to peripheral or central venous catheter (infusion will not be started)

Hypotension Avoidance Strategy

Propofol administration PROCEDURE

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

Hypotension Avoidance Strategy

Alarm adjustment PROCEDURE

Lower mean arterial pressure alarm threshold will be set to 75 mmHg

Hypotension Avoidance Strategy

Intervention threshold PROCEDURE

Lower mean arterial pressure intervention threshold will be 75 mmHg: continuous norepinephrine infusion will be started when mean arterial blood decreases below 75 mmHg

Hypotension Avoidance Strategy

Eligibility Criteria

• Age: 45 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Moritz Flick

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

• Kristen Thomsen

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: May 6, 2023
• Study Start: March 7, 2023
• Primary Completion: August 7, 2023
• Study Completion: August 7, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)