Clinical trial NCT05276596: Evaluation of the Early Use of Norepinephrine in Major Abdominal Surgery on Postoperative Organ Dysfunction
Official title: Evaluation of the Early Use of Norepinephrine in Major Abdominal Surgery on Postoperative Organ Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Norepinephrine
Hypotension
Anesthesiology
Major Abdominal Surgery
Keywords: norepinephrine
ephedrine
Hypotension
anesthesiology
major abdominal surgery
Clavien Dindo score
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


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.

Primary outcomes:
measure: Variation of the of the Clavien Dindo surgical score between both groups
timeFrame: one month
Secondary outcomes:
measure: Variation of duration of hospital stay in days between both groups
timeFrame: one month
measure: Length of intensive care unit stay
timeFrame: 1 month
measure: length of postoperative care unit stay
timeFrame: 1 month
measure: Postoperative renal function
timeFrame: at 48 hours
measure: number of persistent circulatory shock
timeFrame: at 48 hours
measure: number of persistent circulatory shock
timeFrame: at 7 days
measure: number of persistent circulatory shock
timeFrame: at 1 month
measure: number of patients with cardiac rhythm disorder
timeFrame: at 1 month
measure: number of patients with cardiac rhythm disorder
timeFrame: at 48 hours
measure: number of patients with cardiac rhythm disorder
timeFrame: at 7 days
measure: Number of patients with acute coronary syndrome
timeFrame: at 48 hours
measure: Number of patients with acute coronary syndrome
timeFrame: at 1 month
measure: Number of patients with acute coronary syndrome
timeFrame: at 7 days
measure: Number of patients with Postoperative respiratory complications: respiratory infection
timeFrame: at 48 hours
measure: Number of patients with Postoperative respiratory complications: respiratory infection
timeFrame: at 7 days
measure: Number of patients with Postoperative respiratory complications: respiratory infection
timeFrame: at 1 month
measure: Number of patients with Postoperative respiratory complications: atelectasis
timeFrame: at 1 month
measure: Number of patients with Postoperative respiratory complications: atelectasis
timeFrame: at 48 hours
measure: Number of patients with Postoperative respiratory complications: atelectasis
timeFrame: at 7 days
measure: Number of patients with Postoperative respiratory complications: oxygen support
timeFrame: at 7 days
measure: Number of patients with Postoperative respiratory complications: oxygen support
timeFrame: at 48 hours
measure: Number of patients with Postoperative respiratory complications: oxygen support
timeFrame: at 1 month
measure: Number of patients with Postoperative respiratory complications: mechanical ventilation
timeFrame: at 7 days
measure: Number of patients with Postoperative respiratory complications: mechanical ventilation
timeFrame: at 48 hours
measure: Number of patients with Postoperative respiratory complications: non-invasive ventilation
timeFrame: at 48 hours
measure: Number of patients with Postoperative respiratory complications: non-invasive ventilation
timeFrame: at 7 days
measure: Number of patients with Postoperative respiratory complications: non-invasive ventilation
timeFrame: at 1 month
measure: Number of patients with Postoperative respiratory complications: acute respiratory distress syndrome (ARDS)
timeFrame: at 48 hours
measure: Number of patients with Postoperative respiratory complications: acute respiratory distress syndrome (ARDS)
timeFrame: at 7 days
measure: Number of patients with Postoperative respiratory complications: acute respiratory distress syndrome (ARDS)
timeFrame: at 1 month
measure: Number of patients with Infectious complications: sepsis
timeFrame: at 48 hours
measure: Number of patients with Infectious complications: sepsis
timeFrame: at 7 days
measure: Number of patients with Infectious complications: sepsis
timeFrame: at 1 month
measure: Number of patients with Infectious complications: sepsis shock
timeFrame: at 1 month
measure: Number of patients with Infectious complications: sepsis shock
timeFrame: at 48 hours
measure: Number of patients with Infectious complications: sepsis shock
timeFrame: at 7 days
measure: Number of patients with Neurological complications: altered consciousness
timeFrame: at 7 days
measure: Number of patients with Neurological complications: altered consciousness
timeFrame: at 48 hours
measure: Number of patients with Neurological complications: altered consciousness
timeFrame: at 1 month
measure: Number of patients with Neurological complications: stroke
timeFrame: at 1 month
measure: Number of patients with Neurological complications: stroke
timeFrame: at 48 hours
measure: Number of patients with Neurological complications: stroke
timeFrame: at 7 days
measure: Number of patients haematological complications: intraoperative blood loss
timeFrame: at 7 days
measure: Number of patients haematological complications: intraoperative blood loss
timeFrame: at 48 hours
measure: Number of patients haematological complications: blood transfusion and haemostasis disorder
timeFrame: at 48 hours
measure: Number of patients haematological complications: blood transfusion and haemostasis disorder
timeFrame: at 7 days
measure: Volume of intraoperative fluid therapy
timeFrame: at 48 hours
measure: Evaluation of the level of dependence in the activities of daily living
timeFrame: at 1 month post-discharge from the hospital
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References: