Evaluation of the early use of norepinephrine in major abdominal surgery on postoperative organ dysfunction

Evaluation of the early use of norepinephrine in major abdominal surgery on postoperative organ dysfunction - EPON

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001827-41-FR

Enrollment

500

Registered

2021-04-08

Start date

2021-06-11

Completion date

Unknown

Last updated

2022-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

major abdominal surgery

Interventions

Trade Name: NORADRÉNALINE (TARTRATE) AGUETTANT 0,5 mg/mL Product Name: NORADRÉNALINE Pharmaceutical Form: Infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Adult > 50 years • Major abdominal surgery • Weighing more than 50 kg • ASA 2 or more • General anaesthesia Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: o patient allergic to local anesthetics, o infection at the puncture sites, o patient on morphine analgesic over the long term, o patient on antidepressants for neuropathic pain.

Design outcomes

Primary

Measure	Time frame
Main Objective: is to show the effectiveness of the preventive use of noradrenaline in major abdominal surgery on the occurrence of postoperative medical-surgical complication;Secondary Objective: - Length of hospital stay and length of stay in the ICU - Post-operative renal function at 48 hours, 7 days and 1 month post-operatively. - Post-operative cardiovascular complications occurring during the stay - Post-operative respiratory complications occurring during the stay - Infectious complications - Neurological complications - Haematological complications - Volume of intraoperative vascular filling with crystalloids recorded at the end of the operation - Mortality at 1 month - Evaluation of the level of dependence in activities of daily living ;Primary end point(s): is the occurrence of postoperative medical-surgical complications assessed by the Clavien Dindo surgical score. ;Timepoint(s) of evaluation of this end point: day 30	—

Measure

Time frame

Main Objective: is to show the effectiveness of the preventive use of noradrenaline in major abdominal surgery on the occurrence of postoperative medical-surgical complication;Secondary Objective: - Length of hospital stay and length of stay in the ICU - Post-operative renal function at 48 hours, 7 days and 1 month post-operatively. - Post-operative cardiovascular complications occurring during the stay - Post-operative respiratory complications occurring during the stay - Infectious complications - Neurological complications - Haematological complications - Volume of intraoperative vascular filling with crystalloids recorded at the end of the operation - Mortality at 1 month - Evaluation of the level of dependence in activities of daily living ;Primary end point(s): is the occurrence of postoperative medical-surgical complications assessed by the Clavien Dindo surgical score. ;Timepoint(s) of evaluation of this end point: day 30

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Secondary

Measure	Time frame
Secondary end point(s): - Length of hospital stay and length of stay in the ICU at one month - Post-operative renal function assessed by KDIGO score at 48 hours, 7 days and 1 month post-operatively. - Post-operative cardiovascular complications occurring during the stay: circulatory shock defined by the use of catecholamines beyond the twelfth hour post-operatively, cardiac rhythm disorder, myocardial infarction, acute coronary syndrome recorded at forty-eight hours, seven days and one month post-operatively. - Post-operative respiratory complications occurring during the stay: respiratory infection, atelectasis, oxygen deficiency, need for mechanical ventilation or NIV, ARDS at forty-eight hours, seven days and one month post-op. - Infectious complications: sepsis and septic shock as defined in the international definitions (SOFA score) at forty-eight hours, seven days and one month post-op. - Neurological complications: altered consciousness, stroke at forty-eight hours, seven days and one month post-op. - Haematological complications: intraoperative blood loss, recourse to transfusion, crase disorder (decrease in prothrombin rate) at forty-eight hours, seven days and one month post-op. - Volume of intraoperative vascular filling with crystalloids recorded at the end of the operation - Mortality at 1 month - Assessment of the level of dependence in the activities of daily living (IADL or ADL scale at one month following discharge from hospital) ;Timepoint(s) of evaluation of this end point: H48, day 7 and day 30	—

Measure

Time frame

Secondary end point(s): - Length of hospital stay and length of stay in the ICU at one month - Post-operative renal function assessed by KDIGO score at 48 hours, 7 days and 1 month post-operatively. - Post-operative cardiovascular complications occurring during the stay: circulatory shock defined by the use of catecholamines beyond the twelfth hour post-operatively, cardiac rhythm disorder, myocardial infarction, acute coronary syndrome recorded at forty-eight hours, seven days and one month post-operatively. - Post-operative respiratory complications occurring during the stay: respiratory infection, atelectasis, oxygen deficiency, need for mechanical ventilation or NIV, ARDS at forty-eight hours, seven days and one month post-op. - Infectious complications: sepsis and septic shock as defined in the international definitions (SOFA score) at forty-eight hours, seven days and one month post-op. - Neurological complications: altered consciousness, stroke at forty-eight hours, seven days and one month post-op. - Haematological complications: intraoperative blood loss, recourse to transfusion, crase disorder (decrease in prothrombin rate) at forty-eight hours, seven days and one month post-op. - Volume of intraoperative vascular filling with crystalloids recorded at the end of the operation - Mortality at 1 month - Assessment of the level of dependence in the activities of daily living (IADL or ADL scale at one month following discharge from hospital) ;Timepoint(s) of evaluation of this end point: H48, day 7 and day 30

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Countries

France

Contacts

Public ContactClinical project manager

CHU Amiens-Picardie

mattoug.salah@chu-amiens.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 8, 2026