Norepinephrine Weaning in Septic Patients (CATECHOFLOU)

September 30, 2008 updated by: Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Seine-Saint-Denis
      • Bobigny, Seine-Saint-Denis, France, 93000
        • Reanimation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to shock resolution defined as cessation of vasopressor support

Secondary Outcome Measures

Outcome Measure
28 days survival, total amount of norepinephrine infused, duration of mechanical ventilation, and length of stay in the ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

September 30, 2008

First Submitted That Met QC Criteria

September 30, 2008

First Posted (Estimate)

October 1, 2008

Study Record Updates

Last Update Posted (Estimate)

October 1, 2008

Last Update Submitted That Met QC Criteria

September 30, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DH/JF-11-2002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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