Using norepinephrine to prevent complications in major abdominal surgery
Evaluation of the Early Use of Norepinephrine in Major Abdominal Surgery on Postoperative Organ Dysfunction
This study is testing if giving norepinephrine to older patients at high risk during major abdominal surgery can help prevent low blood pressure and improve their recovery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT05276596 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the early use of norepinephrine in patients undergoing major abdominal surgery to prevent intraoperative hypotension and its associated complications. The study focuses on high-risk patients, specifically those with an ASA-PS score of 2 or higher, aged 50 years or older. By administering norepinephrine proactively, the trial aims to assess its effectiveness in reducing the incidence of hypotension during surgery and improving postoperative outcomes. The methodology involves comparing the outcomes of patients receiving norepinephrine against those receiving standard care.
Who should consider this trial
Good fit: Ideal candidates include patients aged 50 and older scheduled for major abdominal surgery with an ASA-PS score of 2 or higher.
Not a fit: Patients undergoing emergency surgery or those with uncontrolled hypertension or severe cardiovascular, renal, or hepatic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative organ dysfunction and improve recovery in high-risk surgical patients.
How similar studies have performed: While some studies have shown promise in using norepinephrine in obstetric surgeries, this specific application in major abdominal surgery is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Amiens
- CHU Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Ottilie FUMERY- TROCHERIS, MD
- Email: fumery.ottilie@chu-amiens.fr
- Phone: 03 22 08 78 36
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.