Norepinephrine Weaning in Septic Patients

Septic Shock Clinical Trial

— CATECHOFLOU  

Official title:

Continuous Administration of Norepinephrine Assisted by Fuzzy Logic Assisted Control in Septic Shock Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763906
• Other study ID #: DH/JF-11-2002
• Status: Completed
• Phase: Phase 4
• First received: September 30, 2008
• Last updated: September 30, 2008
• Start date: November 2004
• Est. completion date: January 2007

Study information

• Verified date: September 2008
• Source: Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence
• Contact: n/a
• Is FDA regulated: No
• Health authority: Delegation Recherche Clinique France:
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2007
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock, Septic

Intervention

Device:
• norepinephrine infused at the clinician's discretion

• norepinephrine infused under computerized fuzzy logic control

Locations

Country	Name	City	State
France	Réanimation	Bobigny	Seine-Saint-Denis

Sponsors (1)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to shock resolution defined as cessation of vasopressor support			Yes
Secondary	28 days survival, total amount of norepinephrine infused, duration of mechanical ventilation, and length of stay in the ICU			Yes