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Norepinephrine Weaning in Septic Patients (CATECHOFLOU)

Primary Purpose

Septic Shock

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
norepinephrine infused at the clinician's discretion
norepinephrine infused under computerized fuzzy logic control
Sponsored by
Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring septic shock, fuzzy logic, norepinephrine weaning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Réanimation

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

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

Full Information

First Posted
September 30, 2008
Last Updated
September 30, 2008
Sponsor
Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence
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1. Study Identification

Unique Protocol Identification Number
NCT00763906
Brief Title
Norepinephrine Weaning in Septic Patients
Acronym
CATECHOFLOU
Official Title
Continuous Administration of Norepinephrine Assisted by Fuzzy Logic Assisted Control in Septic Shock Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
septic shock, fuzzy logic, norepinephrine weaning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Patients were assigned to norepinephrine infused at the clinician's discretion.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patients were assigned to norepinephrine infused under computerized fuzzy logic control.
Intervention Type
Device
Intervention Name(s)
norepinephrine infused at the clinician's discretion
Intervention Type
Device
Intervention Name(s)
norepinephrine infused under computerized fuzzy logic control
Primary Outcome Measure Information:
Title
Time to shock resolution defined as cessation of vasopressor support
Secondary Outcome Measure Information:
Title
28 days survival, total amount of norepinephrine infused, duration of mechanical ventilation, and length of stay in the ICU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Réanimation
City
Bobigny
State/Province
Seine-Saint-Denis
ZIP/Postal Code
93000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
19068113
Citation
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.
Results Reference
derived

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Norepinephrine Weaning in Septic Patients

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