Evaluation of the Early Use of Norepinephrine in Major Abdominal Surgery on Postoperative Organ Dysfunction

Launched by CENTRE HOSPITALIER UNIVERSITAIRE, AMIENS · Mar 3, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of norepinephrine, a medication that helps manage blood pressure, during major abdominal surgeries. The goal is to see if giving norepinephrine early can prevent low blood pressure (hypotension) during surgery, which is common and can lead to serious complications after the procedure. By testing this approach, researchers hope to determine if it can reduce the chances of organ dysfunction and other complications that might occur after surgery.

To participate in this study, you must be an adult over 50 years old, scheduled for major abdominal surgery, and have a certain level of health that meets specific criteria. Some people may not be eligible, such as those with severe high blood pressure, certain heart conditions, or those who are pregnant. If you join the trial, you can expect to receive either norepinephrine or standard care during your surgery, and the medical team will closely monitor your health throughout the process. Your involvement will help improve our understanding of how to keep patients safe during and after surgery.

Gender

ALL

Eligibility 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.