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Norepinephrine Weaning in Septic Patients (CATECHOFLOU)

This study has been completed.
Sponsor:
Information provided by:
Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence
ClinicalTrials.gov Identifier:
NCT00763906
First received: September 30, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Shock
U.S. FDA Resources

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 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 28 days survival, total amount of norepinephrine infused, duration of mechanical ventilation, and length of stay in the ICU [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence

Additional 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
Study First Received: September 30, 2008
Last Updated: September 30, 2008
Health Authority: Delegation Recherche Clinique France:

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
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013