NorepinephrinePhase 3EPONNCT05276596
Evaluation of the Early Use of Norepinephrine in Major Abdominal Surgery on Postoperative Organ Dysfunction
A Phase 3 study testing Ephedrine and Norepinephrine in people with Norepinephrine and Hypotension, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Hemodynamic instability is frequent during surgery and intraoperative hypotension is associated with excess morbidity and excess mortality in high-risk patients. In major abdominal surgery the incidence of intraoperative hypotension remains high. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Norepinephrine, Hypotension, Anesthesiology
- What is being tested?
- Ephedrine and Norepinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 17 Nov 2021to 29 Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for major abdominal surgery (defined as surgery with a risk of cardiovascular complications of >1% and/or lasting more than 2 hours) with general anaesthesia.
- American Society of Anesthesiologists physical status (ASA-PS) score of ≥2.
- Age of ≥50 years and weighing more than 50 kg
- Written informed consent.
Who cannot join
- Emergency surgery.
- Untreated or uncontrolled hypertension (systolic blood pressure of >150 mm Hg), despite medication.
- Any acute cardiovascular event, including acute or decompensated heart failure or acute coronary syndrome.
- Patients with chronic kidney disease with a glomerular filtration rate of <30 ml.min-1/1.73 m2 or requiring renal replacement therapy for end-stage renal disease.
- Patients with severe hepatic failure (ASAT/ALAT of >2N, elevated bilirubin level, PT of <50%).
- Preoperative sepsis, septic shock.
Show all 11Show fewer
- Preoperative norepinephrine infusion.
- Patients eligible for a surgical procedure under locoregional anaesthesia.
- Pregnancy.
- Known allergy to study treatment.
- Patients unable to give informed consent for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Hemodynamic instability is frequent during surgery and intraoperative hypotension is associated with excess morbidity and excess mortality in high-risk patients. In major abdominal surgery the incidence of intraoperative hypotension remains high.
For the past few years, some teams have proposed evaluating norepinephrine as a first-line drug in the presence of hypotension or even before hypotension occurs Thus in obstetrics, the preventive use of norepinephrine for cesareans performed under spinal anesthesia was associated with a reduction in the incidence of hypotension per operative without deleterious effect for the newborn or parturient. In the absence of any observed complications, several teams began to use noradrenaline prophylactically in other surgery. However, no study has demonstrated its benefit, particularly the term of surgical complication in abdominal surgery. The objective of this work is to assess the preventive use of norepinephrine in major abdominal surgery on the occurrence of intraoperative hypotension, postoperative organ dysfunction and postoperative medical and surgical complications.
- Conditions
- Norepinephrine, Hypotension, Anesthesiology, Major Abdominal Surgery
- Being tested
- Ephedrine, Norepinephrine
- Keywords
- norepinephrine, ephedrine, Hypotension, anesthesiology, major abdominal surgery, Clavien Dindo score
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EphedrineDrug
The control group will be taken care of according to the protocols in force. The first anesthetic post-induction hypotension will be managed by intravenous injection of ephedrine (dilution: 3 mg / ml) at a dose of 6 mg (i.e. 2 ml). Any subsequent hypotension will be treated with ephedrine until injection of a total dose of 30 mg. Thereafter, if a new arterial hypotension occurs, we will pass to the administration of noradrenaline in intravenous injection using an electric syringe pump, at the dilution of 0.016 mg / ml, posology adapted to the objectives. blood pressure.
NorepinephrineDrug
Immediately use of norepinephrine by intravenous injection using an electric syringe pump, at a dilution of 0.016 mg / ml, at the time of anesthetic induction and without waiting the 1st possible arterial hypotension. Noradrenaline will be started at a dose of 0.48 mg / h and then adapted according to the blood pressure objectives.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The first anesthetic post-induction hypotension will be managed by intravenous injection of ephedrine (dilution: 3 mg / ml) at a dose of 6 mg (i.e. 2 ml). Any subsequent hypotension will be treated with ephedrine until injection of a total dose of 30 mg. Thereafter, if a new arterial hypotension occurs, we will pass to the administration of noradrenaline in intravenous injection using an electric syringe pump, at the dilution of 0.016 mg / ml, posology adapted to the objectives. blood pressure. Receives: Drug: Ephedrine |
| Test group | Experimental | Immediately use of norepinephrine by intravenous injection using an electric syringe pump, at a dilution of 0.016 mg / ml, at the time of anesthetic induction and without waiting the 1st possible arterial hypotension. Noradrenaline will be started at a dose of 0.48 mg / h and then adapted according to the blood pressure objectives. Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the of the Clavien Dindo surgical score between both groups
The Clavien-Dindo Classification
The therapy used to correct a specific complication is the basis of this classification in order to rank a complication in an objective and reproducible manner.
It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study.
Complications that have the potential for long-lasting disability after patient's discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life
Measured: one month
Secondary outcomes (48)
Variation of duration of hospital stay in days between both groups
Measured: one month
Length of intensive care unit stay
Measured: 1 month
length of postoperative care unit stay
Measured: 1 month
Postoperative renal function
Postoperative renal function assessed by the KDIGO score at 48 hours KDIGO (Kidney Disease: Improving Global Outcomes) stage 1 : Serum creatinine : 1.5-1.9 times baseline or ≥0.3 mg/dl (≥26.5μmol/l) increase stage 2 : Serum creatinine : 2.0-2.9 times baseline stage 3 : 3 times baseline or ≥4.0 mg/dl ( ≥353.6 μmol/l) increase stage 1 : Urine output : <0.5 ml/kg/h for 6-12 h stage 21 :Urine output : <0.5 ml/kg/h for ≥12 h stage 3 : Urine output : <0.3 ml/kg/h ≥24 h or anuria ≥12h
Measured: at 48 hours
number of persistent circulatory shock
persistent circulatory shock defined by the use of vasoactive drugs beyond the 12th hour postoperatively
Measured: at 48 hours
number of persistent circulatory shock
persistent circulatory shock defined by the use of vasoactive drugs beyond the 12th hour postoperatively
Measured: at 7 days
number of persistent circulatory shock
persistent circulatory shock defined by the use of vasoactive drugs beyond the 12th hour postoperatively
Measured: at 1 month
number of patients with cardiac rhythm disorder
number of patients with cardiac rhythm disorder
Measured: at 1 month
number of patients with cardiac rhythm disorder
number of patients with cardiac rhythm disorder
Measured: at 48 hours
number of patients with cardiac rhythm disorder
number of patients with cardiac rhythm disorder
Measured: at 7 days
Number of patients with acute coronary syndrome
Number of patietns with acute coronary syndrome
Measured: at 48 hours
Number of patients with acute coronary syndrome
Number of patietns with acute coronary syndrome
Measured: at 1 month
Number of patients with acute coronary syndrome
Number of patietns with acute coronary syndrome
Measured: at 7 days
Number of patients with Postoperative respiratory complications: respiratory infection
Number of patients with Postoperative respiratory complications: respiratory infection
Measured: at 48 hours
Number of patients with Postoperative respiratory complications: respiratory infection
Number of patients with Postoperative respiratory complications: respiratory infection
Measured: at 7 days
Number of patients with Postoperative respiratory complications: respiratory infection
Number of patients with Postoperative respiratory complications: respiratory infection
Measured: at 1 month
Number of patients with Postoperative respiratory complications: atelectasis
Number of patients with Postoperative respiratory complications: atelectasis
Measured: at 1 month
Number of patients with Postoperative respiratory complications: atelectasis
Number of patients with Postoperative respiratory complications: atelectasis
Measured: at 48 hours
Number of patients with Postoperative respiratory complications: atelectasis
Number of patients with Postoperative respiratory complications: atelectasis
Measured: at 7 days
Number of patients with Postoperative respiratory complications: oxygen support
Number of patients with Postoperative respiratory complications: oxygen support
Measured: at 7 days
Number of patients with Postoperative respiratory complications: oxygen support
Number of patients with Postoperative respiratory complications: oxygen support
Measured: at 48 hours
Number of patients with Postoperative respiratory complications: oxygen support
Number of patients with Postoperative respiratory complications: oxygen support
Measured: at 1 month
Number of patients with Postoperative respiratory complications: mechanical ventilation
Number of patients with Postoperative respiratory complications: mechanical ventilation
Measured: at 7 days
Number of patients with Postoperative respiratory complications: mechanical ventilation
Number of patients with Postoperative respiratory complications: mechanical ventilation
Measured: at 48 hours
Number of patients with Postoperative respiratory complications: non-invasive ventilation
Number of patients with Postoperative respiratory complications: non-invasive ventilation
Measured: at 48 hours
Number of patients with Postoperative respiratory complications: non-invasive ventilation
Number of patients with Postoperative respiratory complications: non-invasive ventilation
Measured: at 7 days
Number of patients with Postoperative respiratory complications: non-invasive ventilation
Number of patients with Postoperative respiratory complications: non-invasive ventilation
Measured: at 1 month
Number of patients with Postoperative respiratory complications: acute respiratory distress syndrome (ARDS)
Number of patients with Postoperative respiratory complications: acute respiratory distress syndrome (ARDS)
Measured: at 48 hours
Number of patients with Postoperative respiratory complications: acute respiratory distress syndrome (ARDS)
Number of patients with Postoperative respiratory complications: acute respiratory distress syndrome (ARDS)
Measured: at 7 days
Number of patients with Postoperative respiratory complications: acute respiratory distress syndrome (ARDS)
Number of patients with Postoperative respiratory complications: acute respiratory distress syndrome (ARDS)
Measured: at 1 month
Number of patients with Infectious complications: sepsis
Number of patients with Infectious complications: sepsis
Measured: at 48 hours
Number of patients with Infectious complications: sepsis
Number of patients with Infectious complications: sepsis
Measured: at 7 days
Number of patients with Infectious complications: sepsis
Number of patients with Infectious complications: sepsis
Measured: at 1 month
Number of patients with Infectious complications: sepsis shock
Number of patients with Infectious complications: sepsis shock septic shock as defined in the international definitions (sepsis-related organ failure assessment score)
Measured: at 1 month
Number of patients with Infectious complications: sepsis shock
Number of patients with Infectious complications: sepsis shock septic shock as defined in the international definitions (sepsis-related organ failure assessment score)
Measured: at 48 hours
Number of patients with Infectious complications: sepsis shock
Number of patients with Infectious complications: sepsis shock septic shock as defined in the international definitions (sepsis-related organ failure assessment score)
Measured: at 7 days
Number of patients with Neurological complications: altered consciousness
Number of patients with Neurological complications: altered consciousness
Measured: at 7 days
Number of patients with Neurological complications: altered consciousness
Number of patients with Neurological complications: altered consciousness
Measured: at 48 hours
Number of patients with Neurological complications: altered consciousness
Number of patients with Neurological complications: altered consciousness
Measured: at 1 month
Number of patients with Neurological complications: stroke
Number of patients with Neurological complications: stroke
Measured: at 1 month
Number of patients with Neurological complications: stroke
Number of patients with Neurological complications: stroke
Measured: at 48 hours
Number of patients with Neurological complications: stroke
Number of patients with Neurological complications: stroke
Measured: at 7 days
Number of patients haematological complications: intraoperative blood loss
Number of patients haematological complications: intraoperative blood loss
Measured: at 7 days
Number of patients haematological complications: intraoperative blood loss
Number of patients haematological complications: intraoperative blood loss
Measured: at 48 hours
Number of patients haematological complications: blood transfusion and haemostasis disorder
Number of patients haematological complications: blood transfusion and haemostasis disorder
Measured: at 48 hours
Number of patients haematological complications: blood transfusion and haemostasis disorder
Number of patients haematological complications: blood transfusion and haemostasis disorder
Measured: at 7 days
Volume of intraoperative fluid therapy
Volume of intraoperative fluid therapy
Measured: at 48 hours
Evaluation of the level of dependence in the activities of daily living
Evaluation of the level of dependence in the activities of daily living : IADL scale The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills There are eight domains of function measured with the Lawton IADL scale. Women are scored on all 8 areas of function; historically, for men, the areas of food preparation, housekeeping, laundering are excluded.
Clients are scored according to their highest level of functioning in that category. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men.
Measured: at 1 month post-discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start17 Nov 2021
- Primary completion17 Dec 2024
- Study completion29 Nov 2025
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 NorepinephrineStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276596
- Sponsor's protocol ID
- PI2021_843_0060
- Acronym
- EPON
- Status last verified
- Dec 2025
- First submitted
- 3 Mar 2022
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trocheris-Fumery O, Scetbon C, Flet T, Meynier J, Sellier M, Rumbach M, Badaoui R, Villeret L, Tarpin P, Abou-Arab O, Bar S, Dupont H. Evaluation of the early use of norepinephrine in major abdominal surgery on medical and surgical postoperative complications: study protocol for a randomised controlled trial (EPON STUDY). BMJ Open. 2024 Apr 29;14(4):e083606. doi: 10.1136/bmjopen-2023-083606.
PubMed 38684243
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Early Use of Norepinephrine in Major Abdominal Surgery on Postoperative Organ Dysfunction
- ClinicalTrials.gov ID
- NCT05276596
- Acronym / sponsor ID
- EPON / PI2021_843_0060
- Conditions
- Norepinephrine, Hypotension, Anesthesiology, Major Abdominal Surgery
- Keywords
- norepinephrine, ephedrine, Hypotension, anesthesiology, major abdominal surgery, Clavien Dindo score
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 29 Nov 2025 (actual)
- First posted
- 11 Mar 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.
Hemodynamic instability is frequent during surgery and intraoperative hypotension is associated with excess morbidity and excess mortality in high-risk patients. In major abdominal surgery the incidence of intraoperative hypotension remains high.
For the past few years, some teams have proposed evaluating norepinephrine as a first-line drug in the presence of hypotension or even before hypotension occurs Thus in obstetrics, the preventive use of norepinephrine for cesareans performed under spinal anesthesia was associated with a reduction in the incidence of hypotension per operative without deleterious effect for the newborn or parturient. In the absence of any observed complications, several teams began to use noradrenaline prophylactically in other surgery. However, no study has demonstrated its benefit, particularly the term of surgical complication in abdominal surgery. The objective of this work is to assess the preventive use of norepinephrine in major abdominal surgery on the occurrence of intraoperative hypotension, postoperative organ dysfunction and postoperative medical and surgical complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: EphedrineThe first anesthetic post-induction hypotension will be managed by intravenous injection of ephedrine (dilution: 3 mg / ml) at a dose of 6 mg (i.e. 2 ml). Any subsequent hypotension will be treated with ephedrine until injection of a total dose of 30 mg. Thereafter, if a new arterial hypotension occurs, we will pass to the administration of noradrenaline in intravenous injection using an electric syringe pump, at the dilution of 0.016 mg / ml, posology adapted to the objectives. blood pressure. |
| Test group | Experimental | Drug: NorepinephrineImmediately use of norepinephrine by intravenous injection using an electric syringe pump, at a dilution of 0.016 mg / ml, at the time of anesthetic induction and without waiting the 1st possible arterial hypotension. Noradrenaline will be started at a dose of 0.48 mg / h and then adapted according to the blood pressure objectives. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for major abdominal surgery (defined as surgery with a risk of cardiovascular complications of >1% and/or lasting more than 2 hours) with general anaesthesia.
- American Society of Anesthesiologists physical status (ASA-PS) score of ≥2.
- Age of ≥50 years and weighing more than 50 kg
- Written informed consent.
Key exclusion criteria (11 listed)
- Emergency surgery.
- Untreated or uncontrolled hypertension (systolic blood pressure of >150 mm Hg), despite medication.
- Any acute cardiovascular event, including acute or decompensated heart failure or acute coronary syndrome.
- Patients with chronic kidney disease with a glomerular filtration rate of <30 ml.min-1/1.73 m2 or requiring renal replacement therapy for end-stage renal disease.
- Patients with severe hepatic failure (ASAT/ALAT of >2N, elevated bilirubin level, PT of <50%).
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 |
|---|---|---|
| EphedrineThe control group will be taken care of according to the protocols in force. The first anesthetic post-induction hypotension will be managed by intravenous injection of ephedrine (dilution: 3 mg / ml) at a dose of 6 mg (i.e. 2 ml). Any subsequent hypotension will be treated with ephedrine until injection of a total dose of 30 mg. Thereafter, if a new arterial hypotension occurs, we will pass to the administration of noradrenaline in intravenous injection using an electric syringe pump, at the dilution of 0.016 mg / ml, posology adapted to the objectives. blood pressure. | Drug | Control group |
| NorepinephrineImmediately use of norepinephrine by intravenous injection using an electric syringe pump, at a dilution of 0.016 mg / ml, at the time of anesthetic induction and without waiting the 1st possible arterial hypotension. Noradrenaline will be started at a dose of 0.48 mg / h and then adapted according to the blood pressure objectives. | Drug | Test group |
Primary outcome
Variation of the of the Clavien Dindo surgical score between both groups
Time frame: one month
The Clavien-Dindo Classification The therapy used to correct a specific complication is the basis of this classification in order to rank a complication in an objective and reproducible manner. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study. Complications that have the potential for long-lasting disability after patient's discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life
48 secondary outcomes
Variation of duration of hospital stay in days between both groups
Time frame: one month
Length of intensive care unit stay
Time frame: 1 month
length of postoperative care unit stay
Time frame: 1 month
Postoperative renal function
Time frame: at 48 hours
number of persistent circulatory shock
Time frame: at 48 hours
number of persistent circulatory shock
Time frame: at 7 days
number of persistent circulatory shock
Time frame: at 1 month
number of patients with cardiac rhythm disorder
Time frame: at 1 month
number of patients with cardiac rhythm disorder
Time frame: at 48 hours
number of patients with cardiac rhythm disorder
Time frame: at 7 days
Number of patients with acute coronary syndrome
Time frame: at 48 hours
Number of patients with acute coronary syndrome
Time frame: at 1 month
Number of patients with acute coronary syndrome
Time frame: at 7 days
Number of patients with Postoperative respiratory complications: respiratory infection
Time frame: at 48 hours
Number of patients with Postoperative respiratory complications: respiratory infection
Time frame: at 7 days
Number of patients with Postoperative respiratory complications: respiratory infection
Time frame: at 1 month
Number of patients with Postoperative respiratory complications: atelectasis
Time frame: at 1 month
Number of patients with Postoperative respiratory complications: atelectasis
Time frame: at 48 hours
Number of patients with Postoperative respiratory complications: atelectasis
Time frame: at 7 days
Number of patients with Postoperative respiratory complications: oxygen support
Time frame: at 7 days
Number of patients with Postoperative respiratory complications: oxygen support
Time frame: at 48 hours
Number of patients with Postoperative respiratory complications: oxygen support
Time frame: at 1 month
Number of patients with Postoperative respiratory complications: mechanical ventilation
Time frame: at 7 days
Number of patients with Postoperative respiratory complications: mechanical ventilation
Time frame: at 48 hours
Number of patients with Postoperative respiratory complications: non-invasive ventilation
Time frame: at 48 hours
Number of patients with Postoperative respiratory complications: non-invasive ventilation
Time frame: at 7 days
Number of patients with Postoperative respiratory complications: non-invasive ventilation
Time frame: at 1 month
Number of patients with Postoperative respiratory complications: acute respiratory distress syndrome (ARDS)
Time frame: at 48 hours
Number of patients with Postoperative respiratory complications: acute respiratory distress syndrome (ARDS)
Time frame: at 7 days
Number of patients with Postoperative respiratory complications: acute respiratory distress syndrome (ARDS)
Time frame: at 1 month
Number of patients with Infectious complications: sepsis
Time frame: at 48 hours
Number of patients with Infectious complications: sepsis
Time frame: at 7 days
Number of patients with Infectious complications: sepsis
Time frame: at 1 month
Number of patients with Infectious complications: sepsis shock
Time frame: at 1 month
Number of patients with Infectious complications: sepsis shock
Time frame: at 48 hours
Number of patients with Infectious complications: sepsis shock
Time frame: at 7 days
Number of patients with Neurological complications: altered consciousness
Time frame: at 7 days
Number of patients with Neurological complications: altered consciousness
Time frame: at 48 hours
Number of patients with Neurological complications: altered consciousness
Time frame: at 1 month
Number of patients with Neurological complications: stroke
Time frame: at 1 month
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 3 Dec 2025.
- Derived from this study: PubMed 38684243Trocheris-Fumery O, Scetbon C, Flet T, Meynier J, Sellier M, Rumbach M, Badaoui R, Villeret L, Tarpin P, Abou-Arab O, Bar S, Dupont H. Evaluation of the early use of norepinephrine in major abdominal surgery on medical and surgical postoperative complications: study protocol for a randomised controlled trial (EPON STUDY). BMJ Open. 2024 Apr 29;14(4):e083606. doi: 10.1136/bmjopen-2023-083606.
- 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 Phase 3 study testing Ephedrine and Norepinephrine in people with Norepinephrine and Hypotension, run by Centre Hospitalier Universitaire, Amiens 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 4 inclusion and 11 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 3 Dec 2025. 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?
Variation of the of the Clavien Dindo surgical score between both groups (time frame: one month). 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 NCT05276596, 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 3 Dec 2025.