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Norepinephrine Weaning in Septic Patients (CATECHOFLOU)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00763906
First Posted: October 1, 2008
Last Update Posted: October 1, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence
  Purpose
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.

Condition Intervention Phase
Septic Shock Device: norepinephrine infused at the clinician's discretion Device: norepinephrine infused under computerized fuzzy logic control Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continuous Administration of Norepinephrine Assisted by Fuzzy Logic Assisted Control in Septic Shock Patients

Resource links provided by NLM:


Further study details as provided by Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence:

Primary Outcome Measures:
  • Time to shock resolution defined as cessation of vasopressor support

Secondary Outcome Measures:
  • 28 days survival, total amount of norepinephrine infused, duration of mechanical ventilation, and length of stay in the ICU

Enrollment: 40
Study Start Date: November 2004
Study Completion Date: January 2007
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763906


Locations
France
Réanimation
Bobigny, Seine-Saint-Denis, France, 93000
Sponsors and Collaborators
Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00763906     History of Changes
Other Study ID Numbers: DH/JF-11-2002
First Submitted: September 30, 2008
First Posted: October 1, 2008
Last Update Posted: October 1, 2008
Last Verified: September 2008

Keywords provided by Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence:
septic shock
fuzzy logic
norepinephrine weaning

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Norepinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents