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Completed

NCT Number: NCT05842759

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

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.

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Key information

Age range

45 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Monitoring

Procedure

Continuous blood pressure monitoring

Norepinephrine preparation

Procedure

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

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

Alarm adjustment

Procedure

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

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

Primary outcomes

  1. Area under a MAP of 65 mmHg

    Time frame: 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 outcomes

  1. Area under threshold

    Time frame: First 15 minutes of induction of general anesthesia

    Area under a MAP of 60, 50, and 40 mmHg [mmHg x min]

  2. Duration

    Time frame: First 15 minutes of induction of general anesthesia

    Duration of MAP <65, <60, <50, and <40 mmHg [min]

  3. Any Hypotension

    Time frame: 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

  4. 1-minute Hypotension

    Time frame: 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

  5. Area above the curve

    Time frame: First 15 minutes of induction of general anesthesia

    Area above a MAP of 100, 110, 120, 140 mmHg [mmHg x min]

  6. Norepinephrine

    Time frame: First 15 minutes of induction of general anesthesia

    Cumulative dose of norepinephrine indexed to body weight [μg kg-1]

Other outcomes

  1. Cardiac Output/Index (Exploratory Endpoint)

    Time frame: First 15 minutes of induction of general anesthesia

    Descriptive analysis including minimum value, duration under threshold, area under threshold, absolute and relative number of patients with at least one episode under threshold.

  2. Stroke Volume/Index (Exploratory Endpoint)

    Time frame: First 15 minutes of induction of general anesthesia

    Descriptive analysis including minimum value, duration under threshold, area under threshold, absolute and relative number of patients with at least one episode under threshold.

  3. dP/dt (Exploratory Endpoint)

    Time frame: First 15 minutes of induction of general anesthesia

    Descriptive analysis including minimum value, duration under threshold, area under threshold, absolute and relative number of patients with at least one episode under threshold.

  4. Eadyn (Exploratory Endpoint)

    Time frame: First 15 minutes of induction of general anesthesia

    Descriptive analysis including minimum value, duration under threshold, area under threshold, absolute and relative number of patients with at least one episode under threshold.

  5. Stroke volume variation (Exploratory Endpoint)

    Time frame: First 15 minutes of induction of general anesthesia

    Descriptive analysis including minimum value, duration under threshold, area under threshold, absolute and relative number of patients with at least one episode under threshold.

  6. Pulse pressure variation (Exploratory Endpoint)

    Time frame: First 15 minutes of induction of general anesthesia

    Descriptive analysis including minimum value, duration under threshold, area under threshold, absolute and relative number of patients with at least one episode under threshold.

  7. Systemic vascular resistance (Exploratory Endpoint)

    Time frame: First 15 minutes of induction of general anesthesia

    Descriptive analysis including minimum value, duration under threshold, area under threshold, absolute and relative number of patients with at least one episode under threshold.

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 6, 2023
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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