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NCT05276596: EPON

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

Completed Phase 3 Last updated 3 December 2025
What this trial tests

Phase 3 trial testing Ephedrine in Norepinephrine in 500 participants. Completed in 29 November 2025.

Timeline
17 November 2021
Primary endpoint
17 December 2024
29 November 2025

Quick facts

Lead sponsorCentre Hospitalier Universitaire, Amiens
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment500
Start date17 November 2021
Primary completion17 December 2024
Estimated completion29 November 2025
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Centre Hospitalier Universitaire, Amiens

Who can join

18 and older, any sex, with Norepinephrine or Hypotension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Early Use of Norepinephrine in High-risk Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Trial.
    Trocheris-Fumery O, Flet T, Scetbon C, Tarpin P, et al · · 2025 · cited 4× · PMID 40758953 · DOI 10.1097/aln.0000000000005704
  2. Evaluation of the early use of norepinephrine in major abdominal surgery on medical and surgical postoperative complications: study protocol for a randomised controlled trial (EPON STUDY).
    Trocheris-Fumery O, Scetbon C, Flet T, Meynier J, et al · · 2024 · cited 1× · PMID 38684243 · DOI 10.1136/bmjopen-2023-083606

Verify or expand the search:

Other trials of Ephedrine

Trials testing the same drug.

Other recruiting trials for Norepinephrine

Currently open trials in the same condition.

Other Centre Hospitalier Universitaire, Amiens trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05276596.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing