NCT00763906

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2008

Completed
Last Updated

October 1, 2008

Status Verified

September 1, 2008

Enrollment Period

2 years

First QC Date

September 30, 2008

Last Update Submit

September 30, 2008

Conditions

Septic Shock

Keywords

septic shockfuzzy logicnorepinephrine weaning

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

1

PLACEBO COMPARATOR

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

Device: norepinephrine infused at the clinician's discretion

2

ACTIVE COMPARATOR

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

Device: norepinephrine infused under computerized fuzzy logic control

Interventions

norepinephrine infused at the clinician's discretionDEVICE
1
norepinephrine infused under computerized fuzzy logic controlDEVICE
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Septic shock

You may not qualify if:

  • Less than 18 years
  • Pregnancy
  • Weight above 135 kg
  • Requirement for continuous epinephrine infusion
  • Severe head injury, stroke, a comatose state following cardiac arrest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Réanimation

Bobigny, Seine-Saint-Denis, 93000, France

Location

Related Publications (1)

  • 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.

    PMID: 19068113DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2008

First Posted

October 1, 2008

Study Start

November 1, 2004

Primary Completion

November 1, 2006

Study Completion

January 1, 2007

Last Updated

October 1, 2008

Record last verified: 2008-09

Locations

FR(1)