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CompletedNCT00763906CATECHOFLOUUpdated Oct 1, 2008

Norepinephrine Weaning in Septic Patients

A Phase 4 interventional study of norepinephrine infused at the clinician's discretion and norepinephrine infused under computerized fuzzy logic control in Septic Shock, sponsored by Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-10-01.

Sponsored by Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The weaning rate of vasopressors drugs is usually chosen empirically by the clinician in critically patients. The investigators applied fuzzy logic principles to modify intravenous norepinephrine infusion rates during norepinephrine infusion in septic patients in order to reduce the duration of shock. The investigators goal was to reduce the duration of poorly controlled hemodynamic status.

02

Conditions studied

  • Septic Shock

Keywords

  • septic shock
  • fuzzy logic
  • norepinephrine weaning
03

In context

Shock, Septic

862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.

This study's enrollment of 40 is below the median of 80 across 530 interventional studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

This is the only study on the registry with Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Septic shock

Exclusion criteria

Exclusion Criteria:

  • Less than 18 years
  • Pregnancy
  • Weight above 135 kg
  • Requirement for continuous epinephrine infusion
  • Severe head injury, stroke, a comatose state following cardiac arrest
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Placebo comparator
    1

    Patients were assigned to norepinephrine infused at the clinician's discretion.

    Device: norepinephrine infused at the clinician's discretion

  • Active comparator
    2

    Patients were assigned to norepinephrine infused under computerized fuzzy logic control.

    Device: norepinephrine infused under computerized fuzzy logic control

Interventions

  • Devicenorepinephrine infused at the clinician's discretion
  • Devicenorepinephrine infused under computerized fuzzy logic control
06

What researchers measure

Primary outcomes

  1. Time to shock resolution defined as cessation of vasopressor support

Secondary outcomes

  1. 28 days survival, total amount of norepinephrine infused, duration of mechanical ventilation, and length of stay in the ICU

07

Study locations

1 site
  • Réanimation
    Bobigny, Seine-Saint-Denis 93000, France
08

References and documents

Publications

  • Merouani M, Guignard B, Vincent F, Borron SW, Karoubi P, Fosse JP, Cohen Y, Clec'h C, Vicaut E, Marbeuf-Gueye C, Lapostolle F, Adnet F. Norepinephrine weaning in septic shock patients by closed loop control based on fuzzy logic. Crit Care. 2008;12(6):R155. doi: 10.1186/cc7149. Epub 2008 Dec 9. PubMed 19068113 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00763906
Lead sponsor
Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence
First posted
Oct 1, 2008
Start date
Nov 2004
Primary completion
Nov 2006
Completion
Jan 2007
Last update
Oct 1, 2008

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

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