Status:
COMPLETED
Evaluation of the Early Use of Norepinephrine in Major Abdominal Surgery on Postoperative Organ Dysfunction
Lead Sponsor:
Centre Hospitalier Universitaire, Amiens
Conditions:
Norepinephrine
Hypotension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 inciden...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
November 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05276596
Start Date
November 17 2021
End Date
November 29 2025
Last Update
December 3 2025
Active Locations (1)
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1
CHU Amiens
Amiens, France, 80480