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

Primary Purpose

Norepinephrine, Hypotension, Anesthesiology

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ephedrine
Norepinephrine
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Norepinephrine focused on measuring norepinephrine, ephedrine, Hypotension, anesthesiology, major abdominal surgery, Clavien Dindo score

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled for major abdominal surgery
  • ASA 2 or more patients
  • Adults> 50 years old
  • Patients eligible for general anesthesia

Exclusion Criteria:

  • Patients scheduled for will be excluded and excluded from the study:
  • ASA 1
  • Children and adults <or = 50 years old
  • Urgent surgery
  • Allergy to a product used in the study
  • Severe untreated or uncontrolled high blood pressure despite taking medication
  • Acute cardiovascular event, including acute or decompensated heart failure and acute coronary syndrome
  • Chronic kidney disease with a glomerular filtration rate of less than 30 ml / min / 1.73 m2 or requiring renal replacement treatment in the event of end-stage renal failure
  • Preoperative sepsis
  • Circulatory shock
  • Preoperative noradrenaline infusion before entering the study
  • Surgical procedure under regional anesthesia (epidural and spinal anesthesia)
  • No affiliation with the French health system
  • Participation in another concurrent intervention study
  • Refusal to participate
  • Pregnant or lactating women

Sites / Locations

  • CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Test group

Arm Description

The first anesthetic post-induction hypotension will be managed by intravenous injection of ephedrine (dilution: 3 mg / ml) at a dose of 6 mg (i.e. 2 ml). Any subsequent hypotension will be treated with ephedrine until injection of a total dose of 30 mg. Thereafter, if a new arterial hypotension occurs, we will pass to the administration of noradrenaline in intravenous injection using an electric syringe pump, at the dilution of 0.016 mg / ml, posology adapted to the objectives. blood pressure.

Immediately use of norepinephrine by intravenous injection using an electric syringe pump, at a dilution of 0.016 mg / ml, at the time of anesthetic induction and without waiting the 1st possible arterial hypotension. Noradrenaline will be started at a dose of 0.48 mg / h and then adapted according to the blood pressure objectives.

Outcomes

Primary Outcome Measures

Variation of the of the Clavien Dindo surgical score between both groups
The Clavien-Dindo Classification The therapy used to correct a specific complication is the basis of this classification in order to rank a complication in an objective and reproducible manner. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study. Complications that have the potential for long-lasting disability after patient's discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life

Secondary Outcome Measures

Variation of duration of hospital stay in days between both groups

Full Information

First Posted
March 3, 2022
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT05276596
Brief Title
Evaluation of the Early Use of Norepinephrine in Major Abdominal Surgery on Postoperative Organ Dysfunction
Acronym
EPON
Official Title
Evaluation of the Early Use of Norepinephrine in Major Abdominal Surgery on Postoperative Organ Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Norepinephrine, Hypotension, Anesthesiology, Major Abdominal Surgery
Keywords
norepinephrine, ephedrine, Hypotension, anesthesiology, major abdominal surgery, Clavien Dindo score

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The first anesthetic post-induction hypotension will be managed by intravenous injection of ephedrine (dilution: 3 mg / ml) at a dose of 6 mg (i.e. 2 ml). Any subsequent hypotension will be treated with ephedrine until injection of a total dose of 30 mg. Thereafter, if a new arterial hypotension occurs, we will pass to the administration of noradrenaline in intravenous injection using an electric syringe pump, at the dilution of 0.016 mg / ml, posology adapted to the objectives. blood pressure.
Arm Title
Test group
Arm Type
Experimental
Arm Description
Immediately use of norepinephrine by intravenous injection using an electric syringe pump, at a dilution of 0.016 mg / ml, at the time of anesthetic induction and without waiting the 1st possible arterial hypotension. Noradrenaline will be started at a dose of 0.48 mg / h and then adapted according to the blood pressure objectives.
Intervention Type
Drug
Intervention Name(s)
Ephedrine
Intervention Description
The control group will be taken care of according to the protocols in force. The first anesthetic post-induction hypotension will be managed by intravenous injection of ephedrine (dilution: 3 mg / ml) at a dose of 6 mg (i.e. 2 ml). Any subsequent hypotension will be treated with ephedrine until injection of a total dose of 30 mg. Thereafter, if a new arterial hypotension occurs, we will pass to the administration of noradrenaline in intravenous injection using an electric syringe pump, at the dilution of 0.016 mg / ml, posology adapted to the objectives. blood pressure.
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
Immediately use of norepinephrine by intravenous injection using an electric syringe pump, at a dilution of 0.016 mg / ml, at the time of anesthetic induction and without waiting the 1st possible arterial hypotension. Noradrenaline will be started at a dose of 0.48 mg / h and then adapted according to the blood pressure objectives.
Primary Outcome Measure Information:
Title
Variation of the of the Clavien Dindo surgical score between both groups
Description
The Clavien-Dindo Classification The therapy used to correct a specific complication is the basis of this classification in order to rank a complication in an objective and reproducible manner. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The introduction of the subclasses a and b allows a contraction of the classification into 5 grades (I, II, III, IV and V) depending on the size of the population observed or the of the focus of a study. Complications that have the potential for long-lasting disability after patient's discharge (e.g.: paralysis of a voice cord after thyroid surgery) are highlighted in the present classification by a suffix ("d" for disability). This suffix indicates that a follow-up is required to comprehensively evaluate the outcome and related long-term quality of life
Time Frame
one month
Secondary Outcome Measure Information:
Title
Variation of duration of hospital stay in days between both groups
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for major abdominal surgery ASA 2 or more patients Adults> 50 years old Patients eligible for general anesthesia Exclusion Criteria: Patients scheduled for will be excluded and excluded from the study: ASA 1 Children and adults <or = 50 years old Urgent surgery Allergy to a product used in the study Severe untreated or uncontrolled high blood pressure despite taking medication Acute cardiovascular event, including acute or decompensated heart failure and acute coronary syndrome Chronic kidney disease with a glomerular filtration rate of less than 30 ml / min / 1.73 m2 or requiring renal replacement treatment in the event of end-stage renal failure Preoperative sepsis Circulatory shock Preoperative noradrenaline infusion before entering the study Surgical procedure under regional anesthesia (epidural and spinal anesthesia) No affiliation with the French health system Participation in another concurrent intervention study Refusal to participate Pregnant or lactating women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ottilie FUMERY- TROCHERIS, MD
Phone
03 22 08 78 36
Email
fumery.ottilie@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ottilie FUMERY- TROCHERIS, MD
Email
fumery.ottilie@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Damien, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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