Cardiac DisorderPhase 3EPITUBE-HEARTNCT05335954
Therapeutic Study Evaluating the Efficacy of Noradrenaline in the Prevention of Hypotension Related to Intubation for Cardiac or Thoracic Surgery
A Phase 3 study testing noradrenaline in people with Cardiac Disorder and Hypotension, run by Nantes University Hospital at 1 site in France.
Trial summary
Arterial hypotension during general anaesthesia (GA) is a serious event. While hypotension can occur during surgery, it usually occurs following induction of GA (i.e. following the injection of drugs to enable intubation). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Disorder, Hypotension
- What is being tested?
- noradrenaline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2022to 12 Dec 2023
- Phase
- Phase 3
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Requiring cardiac or thoracic surgery under general anaesthesia
- Requiring a blood pressure catheter prior to GA induction
Who cannot join
- Hemodynamic instability on arrival in the operating room
- Hypotension on arrival in the operating theatre: Systolic blood pressure < 100 mmHg or Mean arterial pressure < 65 mmHg
- Hypertension on arrival at the operating theatre: Systolic blood pressure > 160 mmHg or Mean arterial pressure > 100 mmHg
- Adult under guardianship, curatorship or safeguard of justice
- Unable to give consent
- Pregnant or breastfeeding woman
Show all 13Show fewer
- Emergency surgery (cannot be delayed by 24 hours)
- Current participation in an interventional protocol that interferes with the evaluation criteria of the study
- Not affiliated to or not benefiting from a social security scheme
- Lack of informed and written consent from the patient
- Patient with a dilated aorta with a risk of rupture (e.g. chronic dissection for example)
- Patient with severe aortic insufficiency
- Treated hypertensive history that may have hypersensitivity to noradrenaline and hypertensive flares hypertensive attacks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Therapeutic Interventional Study Evaluating the Efficacy of Noradrenaline in the Prevention of Hypotension Related to Intubation for Cardiac or Thoracic Surgery - Single-centre Prospective Randomised Controlled Study With Blinded Assessment of the Primary Endpoint
Arterial hypotension during general anaesthesia (GA) is a serious event. While hypotension can occur during surgery, it usually occurs following induction of GA (i.e. following the injection of drugs to enable intubation). This is due to the injection of large doses of anaesthetic drugs with a vasodilatory effect over a short period of time to induce a deep sleep to allow intubation to take place for artificial ventilation.
The prevention of hypotension during surgery has been extensively studied. In contrast, the prevention of hypotension following GA induction has been the subject of only two randomised studies in the ICU and three non-randomised studies in the OR with small numbers of patients. The level of evidence for the use of noradrenaline in the operating theatre remains low.
The hypothesis of the study is that noradrenaline initiated during preoxygenation can reduce the incidence of hypotension during induction of general anaesthesia.
- Conditions
- Cardiac Disorder, Hypotension
- Being tested
- noradrenaline
- Keywords
- general anesthesia, intubation, cardiac surgery, hypotension, noradrenaline
- Medical subject headings
- Heart Diseases, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noradrenalineDrug
noradrenaline
| Study group | Role | What they receive |
|---|---|---|
| Noradrenaline | Experimental | Noradrenaline diluted to 16µg/ml infused at 0.06g/kg/min by peripheral venous line from the start of peripheral venous line from the start of preoxygenation Receives: Drug: noradrenaline |
| Standard care | No intervention | standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation-related hypotension
Occurrence of at least one episode of arterial hypotension defined by a Mean Arterial Pressure below 55 mmHg with Mean Blood Pressure = (Systolic Blood pressure + 2xDiastolic Blood Pressure)/3
Measured: Within 20 minutes of the start of general anesthesia (induction)
Secondary outcomes (26)
Occurrence of complications
Occurrence (yes/no) of complications related to the intubation:
Desaturation < 80%, Severe hypotension (defined as hypotension with systolic blood pressure < 80mmHg), Cardiac arrest, Death during intubation, Difficult intubation (more than two laryngoscopies and/or the use of an alternative technique after optimization of head position, with or without external laryngeal manipulation), Heart rhythm disorder (ventricular extrasystole, ventricular fibrillation, ventricular tachycardia) Esophageal intubation, Regurgitation/inhalation, Tooth breakage
Measured: Within 20 minutes of the start of the intubation
Total dose of vasopressor
Total dose of vasopressors (noradrenaline, ephedrine, neosynephrine)
Measured: Within 20 minutes of the start of the intubation
Duration of episodes of hypotension
Cumulative duration of episodes of hypotension < 55mmHg
Measured: Within 20 minutes of the start of the intubation
Hypotension event
At least one Mean Arterial Pressure measurement < 65 mmHg
Measured: Within 20 minutes of the start of the intubation
Hypertension event
At least one Systolic Blood Pressure measurement > 160 mmHg or Mean Arterial Pressure > 100mmHg
Measured: Within 20 minutes of the start of the intubation
ECC Cardiac Output
Extra Corporeal Circulation generated Cardiac Output frequency in bpm (beat per minute)
Measured: Within 20 minutes of the start of the intubation
ECC Arterial Line Pressure
Extra Corporeal Circulation generated Arterial Line Pressure in mmHg
Measured: Within 20 minutes of the start of the intubation
ECC Arterial Line Temperature
Extra Corporeal Circulation generated Arterial Line Temperature in degree Celcius
Measured: Within 20 minutes of the start of the intubation
ECC Mean Arterial Pressure
Extra Corporeal Circulation generated Mean Arterial Pressure in mmHg
Measured: Within 20 minutes of the start of the intubation
ECC VO2
Extra Corporeal Circulation generated VO2 (Volume O2) in Liter per Minute
Measured: Within 20 minutes of the start of the intubation
ECC duration
Extra Corporeal Circulation duration in minutes
Measured: Within 20 minutes of the start of the intubation
ECC SaO2
Extra Corporeal Circulation generated SaO2 (Arterial Saturation in O2) in percentage
Measured: Within 20 minutes of the start of the intubation
ECC SvO2
Extra Corporeal Circulation generated SvO2 (Venous Saturation in O2) in percentage
Measured: Within 20 minutes of the start of the intubation
ECC PaO2
Extra Corporeal Circulation generated PaO2 (Arterial Pressure in O2) in kPa
Measured: Within 20 minutes of the start of the intubation
ECC PaCO2
Extra Corporeal Circulation generated PaCO2 (Arterial Pressure in CO2) in kPa
Measured: Within 20 minutes of the start of the intubation
Delirium score
At least episode with ICDSC (Intensive Care Delirium Screening Checklist) score of 4 or more (0 to 8, binary interpretation with scores from 0 to 4 excluding the presence of delirium and scores greater than or equal to 4 indicating the presence of delirium, the highest scores are not related with greater intensity of delirium)
Measured: After extubation within 48 hours postoperatively
Duration of Noradrenaline and Dobutamine treatments
Duration of treatment with Noradrenaline (in hours) and Dobutamine (in hours)
Measured: Within 28 days after surgery
PaO2/FiO2
Lowest value of PaO2/FiO2 (Arterial Pressure of O2 / Fraction inspired in Oxygen) measured
Measured: In the 5 post-operative days
Dialysis
Use of dialysis in intensive care (Yes/No)
Measured: Within 28 days after surgery
Hemolysis index
Maximum hemolysis index (0 to 10000, with higher scores being more pejorative)
Measured: In the 5 post-operative days
Acute renal failure
Occurrence of acute renal failure. This criterion will be assessed using the KDIGO (Kidney Disease: Improving Global Outcomes) scale (stage 1 to 3 with higher stages being more pejorative). Any renal attack defined as at least stage I according to this classification (1.5 to 1.9 times the base rate) will be considered as acute renal failure. The "urinary output assessment" component of the KDIGO scale will not be used because of the frequency of use of diuretics in cardiac surgery.
Measured: In the 5 post-operative days
CVA
Occurrence of a CVA (cerebrovascular accident)
Measured: In the 5 post-operative days
Postoperative invasive ventilation duration
Duration of postoperative invasive ventilation in hours: this duration is defined by the duration of mechanical ventilation between arrival in intensive care and extubation
Measured: Until 28 days after surgery
Stay in intensive care duration
Length of stay in intensive care in days: this duration is evaluated between the day of arrival in intensive care and the date on which the patient is considered to have left intensive care (no longer subject to monitoring in intensive care).
Measured: Until 28 days after surgery
Hospitalization duration
Length of hospitalization in days
Measured: Until 28 days after surgery
Mortality
Death of the patient
Measured: Until 28 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 posted20 Apr 2022
- Study start27 Apr 2022
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac DisorderStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mickael VOURC'H, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335954
- Sponsor's protocol ID
- RC21_0144
- Acronym
- EPITUBE-HEART
- Status last verified
- Mar 2024
- First submitted
- 9 Nov 2021
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaillard C, Breul L, Foucher A, Rigal JC, David CH, Souab F, Canevet M, Ryan M, Bailly A, Morin H, Cadiet J, Geay C, Rozec B, Vourc'h M. Prophylactic norepinephrine infusion to reduce severe hypotension during induction of anaesthesia in patients undergoing cardiac surgery: a randomised controlled single-centre clinical trial. Br J Anaesth. 2026 Mar;136(3):856-864. doi: 10.1016/j.bja.2025.10.055. Epub 2025 Dec 11.
PubMed 41381314
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Therapeutic Interventional Study Evaluating the Efficacy of Noradrenaline in the Prevention of Hypotension Related to Intubation for Cardiac or Thoracic Surgery - Single-centre Prospective Randomised Controlled Study With Blinded Assessment of the Primary Endpoint
- ClinicalTrials.gov ID
- NCT05335954
- Acronym / sponsor ID
- EPITUBE-HEART / RC21_0144
- Conditions
- Cardiac Disorder, Hypotension
- Keywords
- general anesthesia, intubation, cardiac surgery, hypotension, noradrenaline
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 20 Apr 2022 (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 during general anaesthesia (GA) is a serious event. While hypotension can occur during surgery, it usually occurs following induction of GA (i.e. following the injection of drugs to enable intubation). This is due to the injection of large doses of anaesthetic drugs with a vasodilatory effect over a short period of time to induce a deep sleep to allow intubation to take place for artificial ventilation.
The prevention of hypotension during surgery has been extensively studied. In contrast, the prevention of hypotension following GA induction has been the subject of only two randomised studies in the ICU and three non-randomised studies in the OR with small numbers of patients. The level of evidence for the use of noradrenaline in the operating theatre remains low.
The hypothesis of the study is that noradrenaline initiated during preoxygenation can reduce the incidence of hypotension during induction of general anaesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noradrenaline | Experimental | Drug: noradrenalineNoradrenaline diluted to 16µg/ml infused at 0.06g/kg/min by peripheral venous line from the start of peripheral venous line from the start of preoxygenation |
| Standard care | No intervention | –standard care |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Requiring cardiac or thoracic surgery under general anaesthesia
- Requiring a blood pressure catheter prior to GA induction
Key exclusion criteria (13 listed)
- Hemodynamic instability on arrival in the operating room
- Hypotension on arrival in the operating theatre: Systolic blood pressure < 100 mmHg or Mean arterial pressure < 65 mmHg
- Hypertension on arrival at the operating theatre: Systolic blood pressure > 160 mmHg or Mean arterial pressure > 100 mmHg
- Adult under guardianship, curatorship or safeguard of justice
- Unable to give consent
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 |
|---|---|---|
| noradrenalinenoradrenaline | Drug | Noradrenaline |
Primary outcome
Intubation-related hypotension
Time frame: Within 20 minutes of the start of general anesthesia (induction)
Occurrence of at least one episode of arterial hypotension defined by a Mean Arterial Pressure below 55 mmHg with Mean Blood Pressure = (Systolic Blood pressure + 2xDiastolic Blood Pressure)/3
26 secondary outcomes
Occurrence of complications
Time frame: Within 20 minutes of the start of the intubation
Total dose of vasopressor
Time frame: Within 20 minutes of the start of the intubation
Duration of episodes of hypotension
Time frame: Within 20 minutes of the start of the intubation
Hypotension event
Time frame: Within 20 minutes of the start of the intubation
Hypertension event
Time frame: Within 20 minutes of the start of the intubation
ECC Cardiac Output
Time frame: Within 20 minutes of the start of the intubation
ECC Arterial Line Pressure
Time frame: Within 20 minutes of the start of the intubation
ECC Arterial Line Temperature
Time frame: Within 20 minutes of the start of the intubation
ECC Mean Arterial Pressure
Time frame: Within 20 minutes of the start of the intubation
ECC VO2
Time frame: Within 20 minutes of the start of the intubation
ECC duration
Time frame: Within 20 minutes of the start of the intubation
ECC SaO2
Time frame: Within 20 minutes of the start of the intubation
ECC SvO2
Time frame: Within 20 minutes of the start of the intubation
ECC PaO2
Time frame: Within 20 minutes of the start of the intubation
ECC PaCO2
Time frame: Within 20 minutes of the start of the intubation
Delirium score
Time frame: After extubation within 48 hours postoperatively
Duration of Noradrenaline and Dobutamine treatments
Time frame: Within 28 days after surgery
PaO2/FiO2
Time frame: In the 5 post-operative days
Dialysis
Time frame: Within 28 days after surgery
Hemolysis index
Time frame: In the 5 post-operative days
Acute renal failure
Time frame: In the 5 post-operative days
CVA
Time frame: In the 5 post-operative days
Postoperative invasive ventilation duration
Time frame: Until 28 days after surgery
Stay in intensive care duration
Time frame: Until 28 days after surgery
Hospitalization duration
Time frame: Until 28 days after surgery
Mortality
Time frame: Until 28 days after surgery
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 7 Mar 2024.
- Derived from this study: PubMed 41381314Gaillard C, Breul L, Foucher A, Rigal JC, David CH, Souab F, Canevet M, Ryan M, Bailly A, Morin H, Cadiet J, Geay C, Rozec B, Vourc'h M. Prophylactic norepinephrine infusion to reduce severe hypotension during induction of anaesthesia in patients undergoing cardiac surgery: a randomised controlled single-centre clinical trial. Br J Anaesth. 2026 Mar;136(3):856-864. doi: 10.1016/j.bja.2025.10.055. Epub 2025 Dec 11.
- Individual participant dataSharing planned: No
Related trials for Cardiac Disorder
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Mickael VOURC'H, MD principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing noradrenaline in people with Cardiac Disorder and Hypotension, run by Nantes University Hospital 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 2 inclusion and 13 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 7 Mar 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Intubation-related hypotension (time frame: Within 20 minutes of the start of general anesthesia (induction)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05335954, which also lists 1 linked publication.
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 7 Mar 2024.