Intraoperative HypotensionINDUCTNCT05940649
Continuous Versus Bolus Administration of Norepinephrine to Treat Hypotension During Anesthetic Induction
A study testing Continuous norepinephrine administration in people with Intraoperative Hypotension, run by Kristen Thomsen at 1 site in Germany.
Trial summary
Intraoperative hypotension is common in patients having non-cardiac surgery with general anesthesia and is associated with organ injury and death. The timely treatment of intraoperative hypotension is thus important to avoid postoperative complications. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Intraoperative Hypotension
- What is being tested?
- Continuous norepinephrine administration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteGermany
- Study dates
- 3 Jul 2023to 1 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-cardiac surgery
- >45 years of age
- American Society of Anesthesiologists physical status classification II, III, and IV.
Who cannot join
- Planned intraarterial blood pressure monitoring during anesthetic induction with an arterial catheter
- Emergency surgery
- Transplant surgery
- History of organ transplant
- Pregnancy
- Heart rhythms other than sinus rhythm
- Impossible Finger-cuff blood pressure monitoring
- Rapid sequence induction
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20251
About this study
Official title: Continuous Versus Bolus Administration of Norepinephrine to Treat Hypotension During Anesthetic Induction - the INDUCT Randomized Trial
Intraoperative hypotension is common in patients having non-cardiac surgery with general anesthesia and is associated with organ injury and death. The timely treatment of intraoperative hypotension is thus important to avoid postoperative complications. About one third of intraoperative hypotension occurs during anesthetic induction - i.e., between the start of anesthetic induction and surgical incision. Hypotension during anesthetic induction is associated with postoperative acute kidney injury.
Unmodifiable risk factors for hypotension during anesthetic induction include age, male sex, and a high American Society of Anesthesiologists physical status class. However, hypotension during anesthetic induction is mainly driven by modifiable factors - specifically, anesthetic drugs that cause vasodilation.
Read more
In most German hospitals, norepinephrine is the first-line vasopressor to treat hypotension during anesthetic induction. Norepinephrine is usually given as repeated manual boluses of 5, 10, or 20 μg. The continuous administration of norepinephrine via a perfusion pump is usually started only later. It remains unknown whether giving norepinephrine continuously - compared to giving it as repeated manual boluses - reduces hypotension during anesthetic induction.
We thus propose to investigate whether giving norepinephrine continuously - compared to giving it as repeated manual boluses - reduces hypotension during anesthetic induction in non-cardiac surgery patients.
- Conditions
- Intraoperative Hypotension
- Being tested
- Continuous norepinephrine administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous norepinephrine administrationProcedure or surgery
In patients randomized to continuous norepinephrine administration, hypotension (= mean arterial pressure < 65mmHg) will be treated with continuous norepinephrine infusion. The norepinephrine perfusion line will be connected to the saline infusion line using a three-way valve. Treating anesthesiologists will be free to reduce or increase the norepinephrine infusion rate anytime.
| Study group | Role | What they receive |
|---|---|---|
| Continuous norepinephrine administration | Experimental | Not described Receives: Procedure: Continuous norepinephrine administration |
| Bolus norepinephrine administration | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension during anesthetic induction
Area under a MAP of 65 mmHg [mmHg x min]
Measured: First 15 minutes of anesthetic induction
Secondary outcomes (8)
Hypotension during anesthetic induction
Area under a MAP of 60, 50, and 40 mmHg [mmHg x min]
Measured: First 15 minutes of anesthetic induction
Hypotension during anesthetic induction
Duration of a MAP <65, <60, <50, and <40 mmHg [min]
Measured: First 15 minutes of anesthetic induction
Hypertension during anesthetic induction
Duration of a MAP >100, >110, >120, and >140 mmHg [min]
Measured: First 15 minutes of anesthetic induction
Hypertension during anesthetic induction
Area above a MAP of 100, 110, 120, and 140 mmHg [mmHg x min]
Measured: First 15 minutes of anesthetic induction
Hypertension during anesthetic induction
Absolute [n] and relative [%] number of patients with any MAP measurement >100, >110, >120 and >140 mmHg
Measured: First 15 minutes of anesthetic induction
Hypotension during anesthetic induction
Absolute [n] and relative [%] number of patients with any MAP measurement <65, <60, <50, and <40 mmHg
Measured: First 15 minutes of anesthetic induction
Hypotension during anesthetic induction
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 anesthetic induction
Hypotension during anesthetic induction
Cumulative dose of norepinephrine indexed to body weight [μg kg-1]
Measured: First 15 minutes of anesthetic induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start3 Jul 2023
- Primary completion6 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristen Thomsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristen Thomsen, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940649
- Sponsor's protocol ID
- 2023-100999-BO-ff
- Other IDs
- 2023
- Acronym
- INDUCT
- Status last verified
- Nov 2024
- First submitted
- 4 Jul 2023
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- 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 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Bolus Administration of Norepinephrine to Treat Hypotension During Anesthetic Induction - the INDUCT Randomized Trial
- ClinicalTrials.gov ID
- NCT05940649
- Acronym / sponsor ID
- INDUCT / 2023-100999-BO-ff
- Conditions
- Intraoperative Hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Kristen ThomsenUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 11 Jul 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.
Intraoperative hypotension is common in patients having non-cardiac surgery with general anesthesia and is associated with organ injury and death. The timely treatment of intraoperative hypotension is thus important to avoid postoperative complications. About one third of intraoperative hypotension occurs during anesthetic induction - i.e., between the start of anesthetic induction and surgical incision. Hypotension during anesthetic induction is associated with postoperative acute kidney injury.
Unmodifiable risk factors for hypotension during anesthetic induction include age, male sex, and a high American Society of Anesthesiologists physical status class. However, hypotension during anesthetic induction is mainly driven by modifiable factors - specifically, anesthetic drugs that cause vasodilation.
In most German hospitals, norepinephrine is the first-line vasopressor to treat hypotension during anesthetic induction. Norepinephrine is usually given as repeated manual boluses of 5, 10, or 20 μg. The continuous administration of norepinephrine via a perfusion pump is usually started only later. It remains unknown whether giving norepinephrine continuously - compared to giving it as repeated manual boluses - reduces hypotension during anesthetic induction.
We thus propose to investigate whether giving norepinephrine continuously - compared to giving it as repeated manual boluses - reduces hypotension during anesthetic induction in non-cardiac surgery patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous norepinephrine administration | Experimental | Procedure: Continuous norepinephrine administration |
| Bolus norepinephrine administration | No intervention | – |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- non-cardiac surgery
- >45 years of age
- American Society of Anesthesiologists physical status classification II, III, and IV.
Key exclusion criteria (8 listed)
- Planned intraarterial blood pressure monitoring during anesthetic induction with an arterial catheter
- Emergency surgery
- Transplant surgery
- History of organ transplant
- 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 |
|---|---|---|
| Continuous norepinephrine administrationIn patients randomized to continuous norepinephrine administration, hypotension (= mean arterial pressure < 65mmHg) will be treated with continuous norepinephrine infusion. The norepinephrine perfusion line will be connected to the saline infusion line using a three-way valve. Treating anesthesiologists will be free to reduce or increase the norepinephrine infusion rate anytime. | Procedure or surgery | Continuous norepinephrine administration |
Primary outcome
Hypotension during anesthetic induction
Time frame: First 15 minutes of anesthetic induction
Area under a MAP of 65 mmHg [mmHg x min]
8 secondary outcomes
Hypotension during anesthetic induction
Time frame: First 15 minutes of anesthetic induction
Hypotension during anesthetic induction
Time frame: First 15 minutes of anesthetic induction
Hypertension during anesthetic induction
Time frame: First 15 minutes of anesthetic induction
Hypertension during anesthetic induction
Time frame: First 15 minutes of anesthetic induction
Hypertension during anesthetic induction
Time frame: First 15 minutes of anesthetic induction
Hypotension during anesthetic induction
Time frame: First 15 minutes of anesthetic induction
Hypotension during anesthetic induction
Time frame: First 15 minutes of anesthetic induction
Hypotension during anesthetic induction
Time frame: First 15 minutes of anesthetic induction
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 15 Nov 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous norepinephrine administration in people with Intraoperative Hypotension, run by Kristen Thomsen 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 3 inclusion and 8 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 15 Nov 2024. 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?
Hypotension during anesthetic induction (time frame: First 15 minutes of anesthetic induction). 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 15 Nov 2024.