HypotensionNCT05842759
Avoiding Postinduction Hypotension: the Clinical ZERO-HYPOTENSION Proof-of-concept Study
A study testing Monitoring, Norepinephrine preparation and Propofol administration in people with Hypotension and Anesthesia, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 45 to 130 years
- Conditions the study is for
- Hypotension, Anesthesia, Hypotension on Induction
- What is being tested?
- Monitoring, Norepinephrine preparation and Propofol administration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 7 Mar 2023to 7 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status classification III or higher, and in whom intraarterial blood pressure monitoring is planned for clinical indication
Who cannot join
- Emergency surgery
- Transplant surgery
- History of organ transplant
- Sepsis
- Pregnancy
- Contraindications for the use of propofol
- Rapid sequence induction
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Hypotension, Anesthesia, Hypotension on Induction
- Being tested
- Monitoring, Norepinephrine preparation, Propofol administration, Alarm adjustment, Intervention threshold
- Keywords
- Hypotension, Low Blood Pressure, Anesthesia Induction, Surgery
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonitoringProcedure or surgery
Continuous blood pressure monitoring
Norepinephrine preparationProcedure or surgery
Norepinephrine infusion will be prepared and connected to peripheral or central venous catheter (infusion will not be started)
Propofol administrationProcedure or surgery
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 adjustmentProcedure or surgery
Lower mean arterial pressure alarm threshold will be set to 75 mmHg
Intervention thresholdProcedure or surgery
Lower mean arterial pressure intervention threshold will be 75 mmHg: continuous norepinephrine infusion will be started when mean arterial blood decreases below 75 mmHg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Monitoring; Procedure: Norepinephrine preparation; Procedure: Propofol administration; Procedure: Alarm adjustment; Procedure: Intervention threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: First 15 minutes of induction of general anesthesia
Secondary outcomes (6)
Area under threshold
Area under a MAP of 60, 50, and 40 mmHg [mmHg x min]
Measured: First 15 minutes of induction of general anesthesia
Duration
Duration of MAP <65, <60, <50, and <40 mmHg [min]
Measured: First 15 minutes of induction of general anesthesia
Any Hypotension
Absolute [n] and relative [%] number of patients with any MAP measurement <65, <60, <50, and <40 mmHg
Measured: First 15 minutes of induction of general anesthesia
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
Measured: First 15 minutes of induction of general anesthesia
Area above the curve
Area above a MAP of 100, 110, 120, 140 mmHg [mmHg x min]
Measured: First 15 minutes of induction of general anesthesia
Norepinephrine
Cumulative dose of norepinephrine indexed to body weight [μg kg-1]
Measured: First 15 minutes of induction of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start7 Mar 2023
- Primary completion7 Aug 2023
- Study completion7 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moritz Flick, Principal investigator, Universitätsklinikum Hamburg-EppendorfKristen Thomsen, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842759
- Sponsor's protocol ID
- 2022-100896-BO-ff
- Status last verified
- Sep 2023
- First submitted
- 5 Mar 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avoiding Postinduction Hypotension: the Clinical ZERO-HYPOTENSION Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT05842759
- Acronym / sponsor ID
- 2022-100896-BO-ff
- Conditions
- Hypotension, Anesthesia, Hypotension on Induction
- Keywords
- Hypotension, Low Blood Pressure, Anesthesia Induction, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 7 Aug 2023 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hypotension Avoidance Strategy | Other | Procedure: Monitoring, Procedure: Norepinephrine preparation, Procedure: Propofol administration, Procedure: Alarm adjustment, Procedure: Intervention thresholdAfter 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. |
Who may qualify
- Ages
- 45 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists physical status classification III or higher, and in whom intraarterial blood pressure monitoring is planned for clinical indication
Key exclusion criteria (7 listed)
- Emergency surgery
- Transplant surgery
- History of organ transplant
- Sepsis
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MonitoringContinuous blood pressure monitoring | Procedure or surgery | Hypotension Avoidance Strategy |
| Norepinephrine preparationNorepinephrine infusion will be prepared and connected to peripheral or central venous catheter (infusion will not be started) | Procedure or surgery | Hypotension Avoidance Strategy |
| Propofol administrationPropofol 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 | Procedure or surgery | Hypotension Avoidance Strategy |
| Alarm adjustmentLower mean arterial pressure alarm threshold will be set to 75 mmHg | Procedure or surgery | Hypotension Avoidance Strategy |
| Intervention thresholdLower mean arterial pressure intervention threshold will be 75 mmHg: continuous norepinephrine infusion will be started when mean arterial blood decreases below 75 mmHg | Procedure or surgery | Hypotension Avoidance Strategy |
Primary outcome
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].
6 secondary outcomes
Area under threshold
Time frame: First 15 minutes of induction of general anesthesia
Duration
Time frame: First 15 minutes of induction of general anesthesia
Any Hypotension
Time frame: First 15 minutes of induction of general anesthesia
1-minute Hypotension
Time frame: First 15 minutes of induction of general anesthesia
Area above the curve
Time frame: First 15 minutes of induction of general anesthesia
Norepinephrine
Time frame: First 15 minutes of induction of general anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moritz Flick principal investigator
Universitätsklinikum Hamburg-Eppendorf
Kristen Thomsen principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring, Norepinephrine preparation and Propofol administration in people with Hypotension and Anesthesia, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under a MAP of 65 mmHg (time frame: First 15 minutes of induction of general anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.