Septic ShockPhase 4CATECHOFLOUNCT00763906
Norepinephrine Weaning in Septic Patients
A Phase 4 study testing norepinephrine infused at the clinician's discretion in people with Septic Shock, run by Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- norepinephrine infused at the clinician's discretion
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2004to Jan 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Septic shock
Who cannot join
- Less than 18 years
- Pregnancy
- Weight above 135 kg
- Requirement for continuous epinephrine infusion
- Severe head injury, stroke, a comatose state following cardiac arrest
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Septic Shock
- Being tested
- norepinephrine infused at the clinician's discretion, norepinephrine infused under computerized fuzzy logic control
- Keywords
- septic shock, fuzzy logic, norepinephrine weaning
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
norepinephrine infused at the clinician's discretionDevice
norepinephrine infused under computerized fuzzy logic controlDevice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Patients were assigned to norepinephrine infused at the clinician's discretion. Receives: Device: norepinephrine infused at the clinician's discretion |
| 2 | Active comparator | Patients were assigned to norepinephrine infused under computerized fuzzy logic control. Receives: Device: norepinephrine infused under computerized fuzzy logic control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to shock resolution defined as cessation of vasopressor support
Secondary outcomes (1)
28 days survival, total amount of norepinephrine infused, duration of mechanical ventilation, and length of stay in the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startNov 2004
- Primary completionNov 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00763906
- Sponsor's protocol ID
- DH/JF-11-2002
- Acronym
- CATECHOFLOU
- Status last verified
- Sep 2008
- First submitted
- 30 Sep 2008
- Last updated
- 1 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19068113
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Administration of Norepinephrine Assisted by Fuzzy Logic Assisted Control in Septic Shock Patients
- ClinicalTrials.gov ID
- NCT00763906
- Acronym / sponsor ID
- CATECHOFLOU / DH/JF-11-2002
- Conditions
- Septic Shock
- Keywords
- septic shock, fuzzy logic, norepinephrine weaning
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'UrgenceUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Nov 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 1 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Device: norepinephrine infused at the clinician's discretionPatients were assigned to norepinephrine infused at the clinician's discretion. |
| 2 | Active comparator | Device: norepinephrine infused under computerized fuzzy logic controlPatients were assigned to norepinephrine infused under computerized fuzzy logic control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Septic shock
Key exclusion criteria (5 listed)
- Less than 18 years
- Pregnancy
- Weight above 135 kg
- Requirement for continuous epinephrine infusion
- Severe head injury, stroke, a comatose state following cardiac arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| norepinephrine infused at the clinician's discretion | Device | 1 |
| norepinephrine infused under computerized fuzzy logic control | Device | 2 |
Primary outcome
Time to shock resolution defined as cessation of vasopressor support
1 secondary outcome
28 days survival, total amount of norepinephrine infused, duration of mechanical ventilation, and length of stay in the ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2008.
- Derived from this study: PubMed 19068113Merouani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing norepinephrine infused at the clinician's discretion in people with Septic Shock, run by Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to shock resolution defined as cessation of vasopressor support. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00763906, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2008; AzTrials last refreshed its copy on 30 Oct 2026.