HypotensionNORAFLOWNCT06350929
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
An observational study of Hypotension, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Arterial hypotension is a frequent complication of general anesthesia and a significant contributor to postoperative complications. It is a critical marker for the development of acute renal failure and postoperative myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension
- What is being tested?
- Cardiac output monitoring by the Starling™ SV Sebac®
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes patients with heart failure and left ventricular failure with a ventricular ejection fraction less than or equal to 40%.
Who may be able to join
- Adult patients
- Heart failure patients with left ventricular failure with a ventricular ejection fraction less than or equal to 40% evaluated by trans-thoracic echocardiography less than a year ago and specifying in particular the patient's filling pressures at the state stable.
- Patients under treatment adapted to the level of heart failure according to the 2021 European Society of Cardiology recommendations.
- Scheduled surgery under general anesthesia.
- Invasive hemodynamic monitoring planned by the anesthetist-resuscitator (irrespective of potential inclusion in the protocol): arterial catheter and central venous line for measurement of CVP (central venous pressure).
- Postoperative monitoring planned in intensive care or intensive care
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- Presence of controlled mechanical ventilation with tidal volumes between 8 and 10 ml/kg of ideal weight.
- Presence of arterial hypotension after induction of general anesthesia, and before surgical stimulation.
- Patient affiliated to a social security scheme or equivalent
- No opposition from the patient.
Who cannot join
- Chronic heart failure patients with right ventricular failure.
- Patients presenting signs of acute pulmonary edema, Pulmonary arterial hypertension (PAH), severe valvular disease, intracardiac shunt.
- Patients operated on under general anesthesia but maintaining spontaneous ventilation.
- Patients with respiratory compliance disorders with compliances greater than 30 cm of water.
- Patients with intra-abdominal hypertension.
- Patients with supraventricular or ventricular arrhythmia.
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- Patients treated with catecholamines prior to the procedure.
- Patients operated on for urgent surgeries
- Patient under guardianship, curatorship or safeguard of justice
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Toulouse Rangueil
Toulouse, 31400
François LABASTE, Dr, 0561322822 ext. +33, labaste.f@chu-toulouse.fr
About this study
Official title: Evaluation of Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients in the Operating Room.
Arterial hypotension is a frequent complication of general anesthesia and a significant contributor to postoperative complications. It is a critical marker for the development of acute renal failure and postoperative myocardial infarction. Chronic heart failure (CHF) patients are increasingly encountered in the operating room, and their perioperative morbidity and mortality are substantial, with specific management lacking precise recommendations.
The main objective is to assess the impact of a diluted norepinephrine bolus on cardiac output in chronic heart failure patients experiencing arterial hypotension after anesthesia induction.
Read the detailed description
Arterial hypotension is a frequent complication of general anesthesia and a significant contributor to postoperative complications. It is a critical marker for the development of acute renal failure and postoperative myocardial infarction. Chronic heart failure (CHF) patients are increasingly encountered in the operating room, and their perioperative morbidity and mortality are substantial, with specific management lacking precise recommendations. The potential indications for norepinephrine use are expanding due to dilution methods allowing peripheral catheter administration, particularly for addressing arterial hypotension during general anesthesia induction. However, these indications are primarily based on common practices, and the impact of norepinephrine on cardiac output in patients with chronic heart failure is poorly understood. The main objective is to assess the impact of a diluted norepinephrine bolus on cardiac output in chronic heart failure patients experiencing arterial hypotension after anesthesia induction.
- Conditions
- Hypotension
- Being tested
- Cardiac output monitoring by the Starling™ SV Sebac®
- Keywords
- Chronic heart failure, Norepinephrine, General anaesthesia
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac output monitoring by the Starling™ SV Sebac®Other
During the surgery, the channels and monitoring equipment will be set up according to the usual procedure in the vascular surgery department. As part of the research, the Starling™ SV Sebac® electrodes will be installed (to measure cardiac flow, cardiac index (CI), stroke volume (VES), variations in stroke volume (VVES), and peripheral resistors (TPRI)).
Once the equipment is in place, anesthetic induction will be carried out according to the usual protocol with curarization and mechanical ventilation.
If the appearance of arterial hypotension is noted after anesthetic induction and mechanical ventilation, the patient will be definitively included in the study. As recommended, he will receive norepinephrine to treat hypotension.
The measurements from the monitoring will be collected at 3, 5, and 10 min after the administration of norepinephrine.
10 days after admission to the operating room, hospitalization data will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Research procedures | Patients with heart failure Receives: Other: Cardiac output monitoring by the Starling™ SV Sebac® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the impact of a bolus of diluted norepinephrine on cardiac output in chronic heart failure patients presenting with arterial hypotension after anesthetic induction.
The evolution of the value of cardiac output assessed by non-invasive monitoring, using bioreactance: Starling™ SV Sebac®.
Measured: During the surgery.
Secondary outcomes (4)
Evaluation of the role of preload dependence before anesthetic induction in the variation of cardiac output after a norepinephrine bolus.
Measurement of pulse pressure difference.
Measured: During the surgery.
Evaluation of the impact of the norepinephrine bolus on blood pressure correction.
Evolution of the monitoring data: systolic blood pressure (SBP - mmHg).
Measured: During the surgery.
Evaluation of the impact of the norepinephrine bolus on heart rate.
Evolution of the monitoring data: heart rate (HR - bpm).
Measured: During the surgery.
Evaluation of the safety of use of norepinephrine in chronic heart failure patients during hospitalization.
Monitoring the appearance of side effects during post-operative hospitalization on the assessments usually carried out in the department and including.
Measured: For 10 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start17 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François LABASTE, Dr, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350929
- Sponsor's protocol ID
- RC31/24/0017
- Acronym
- NORAFLOW
- Status last verified
- Nov 2026
- First submitted
- 28 Mar 2024
- Last updated
- 5 Nov 2026
- 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 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients in the Operating Room.
- ClinicalTrials.gov ID
- NCT06350929
- Acronym / sponsor ID
- NORAFLOW / RC31/24/0017
- Conditions
- Hypotension
- Keywords
- Chronic heart failure, Norepinephrine, General anaesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Apr 2024 (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.
Arterial hypotension is a frequent complication of general anesthesia and a significant contributor to postoperative complications. It is a critical marker for the development of acute renal failure and postoperative myocardial infarction. Chronic heart failure (CHF) patients are increasingly encountered in the operating room, and their perioperative morbidity and mortality are substantial, with specific management lacking precise recommendations.
The main objective is to assess the impact of a diluted norepinephrine bolus on cardiac output in chronic heart failure patients experiencing arterial hypotension after anesthesia induction.
Detailed description
Arterial hypotension is a frequent complication of general anesthesia and a significant contributor to postoperative complications. It is a critical marker for the development of acute renal failure and postoperative myocardial infarction. Chronic heart failure (CHF) patients are increasingly encountered in the operating room, and their perioperative morbidity and mortality are substantial, with specific management lacking precise recommendations. The potential indications for norepinephrine use are expanding due to dilution methods allowing peripheral catheter administration, particularly for addressing arterial hypotension during general anesthesia induction. However, these indications are primarily based on common practices, and the impact of norepinephrine on cardiac output in patients with chronic heart failure is poorly understood. The main objective is to assess the impact of a diluted norepinephrine bolus on cardiac output in chronic heart failure patients experiencing arterial hypotension after anesthesia induction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research procedures | – | Other: Cardiac output monitoring by the Starling™ SV Sebac®Patients with heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients with heart failure and left ventricular failure with a ventricular ejection fraction less than or equal to 40%.
Key inclusion criteria (10 listed)
- Adult patients
- Heart failure patients with left ventricular failure with a ventricular ejection fraction less than or equal to 40% evaluated by trans-thoracic echocardiography less than a year ago and specifying in particular the patient's filling pressures at the state stable.
- Patients under treatment adapted to the level of heart failure according to the 2021 European Society of Cardiology recommendations.
- Scheduled surgery under general anesthesia.
- Invasive hemodynamic monitoring planned by the anesthetist-resuscitator (irrespective of potential inclusion in the protocol): arterial catheter and central venous line for measurement of CVP (central venous pressure).
Key exclusion criteria (10 listed)
- Chronic heart failure patients with right ventricular failure.
- Patients presenting signs of acute pulmonary edema, Pulmonary arterial hypertension (PAH), severe valvular disease, intracardiac shunt.
- Patients operated on under general anesthesia but maintaining spontaneous ventilation.
- Patients with respiratory compliance disorders with compliances greater than 30 cm of water.
- Patients with intra-abdominal hypertension.
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 |
|---|---|---|
| Cardiac output monitoring by the Starling™ SV Sebac®During the surgery, the channels and monitoring equipment will be set up according to the usual procedure in the vascular surgery department. As part of the research, the Starling™ SV Sebac® electrodes will be installed (to measure cardiac flow, cardiac index (CI), stroke volume (VES), variations in stroke volume (VVES), and peripheral resistors (TPRI)). Once the equipment is in place, anesthetic induction will be carried out according to the usual protocol with curarization and mechanical ventilation. If the appearance of arterial hypotension is noted after anesthetic induction and mechanical ventilation, the patient will be definitively included in the study. As recommended, he will receive norepinephrine to treat hypotension. The measurements from the monitoring will be collected at 3, 5, and 10 min after the administration of norepinephrine. 10 days after admission to the operating room, hospitalization data will be collected. | Other | Research procedures |
Primary outcome
Evaluation of the impact of a bolus of diluted norepinephrine on cardiac output in chronic heart failure patients presenting with arterial hypotension after anesthetic induction.
Time frame: During the surgery.
The evolution of the value of cardiac output assessed by non-invasive monitoring, using bioreactance: Starling™ SV Sebac®.
4 secondary outcomes
Evaluation of the role of preload dependence before anesthetic induction in the variation of cardiac output after a norepinephrine bolus.
Time frame: During the surgery.
Evaluation of the impact of the norepinephrine bolus on blood pressure correction.
Time frame: During the surgery.
Evaluation of the impact of the norepinephrine bolus on heart rate.
Time frame: During the surgery.
Evaluation of the safety of use of norepinephrine in chronic heart failure patients during hospitalization.
Time frame: For 10 days after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- 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.
François LABASTE, Dr principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension, run by University Hospital, Toulouse at 1 site in France.
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 10 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François LABASTE, Dr (0561322822 ext. +33, labaste.f@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the impact of a bolus of diluted norepinephrine on cardiac output in chronic heart failure patients presenting with arterial hypotension after anesthetic induction. (time frame: During the surgery.). 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 5 Nov 2026.