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Norepinephrine Weaning in Septic Patients

NCT ID: NCT00763906

Last Updated: 2008-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Septic Shock

Keywords

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septic shock fuzzy logic norepinephrine weaning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type PLACEBO_COMPARATOR

norepinephrine infused at the clinician's discretion

Intervention Type DEVICE

2

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

Group Type ACTIVE_COMPARATOR

norepinephrine infused under computerized fuzzy logic control

Intervention Type DEVICE

Interventions

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norepinephrine infused at the clinician's discretion

Intervention Type DEVICE

norepinephrine infused under computerized fuzzy logic control

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Septic shock

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence

OTHER

Sponsor Role lead

Locations

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Réanimation

Bobigny, Seine-Saint-Denis, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 19068113 (View on PubMed)

Other Identifiers

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DH/JF-11-2002

Identifier Type: -

Identifier Source: org_study_id