NCT00440102

Brief Summary

The expected benefit is a reduction of the morbidity of patients admitted in the intensive care unit having received ketamine for intubation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
655

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2007

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

September 22, 2011

Status Verified

May 1, 2007

Enrollment Period

11 months

First QC Date

February 23, 2007

Last Update Submit

September 21, 2011

Conditions

Intubation; Difficult

Keywords

ETOMIDATEKETAMINERAPID SEQUENCE INTUBATIONPREHOSPITALDuring rapid sequence intubation

Outcome Measures

Primary Outcomes (1)

  • Maximal value of the "Sepsis-related Organ Failure" Assessment (SOFA)

    at the end of D2

Secondary Outcomes (5)

  • Mortality, length of stay in the intensive care unit and in the hospital, length of stay under artificial ventilation, neurological state at the exit of the hospital and adverse effects : within the first 28 days.

    at D0

  • intubation difficulty

    at D0

  • early complications

    at D0

  • adverse effects

    at D0

  • SOFA in the first 48 hours of hospitalization

    at the ende of D2

Study Arms (2)

1

ACTIVE COMPARATOR

ketamine

Drug: Ketamine

2

ACTIVE COMPARATOR

Etomidate

Drug: Etomidate

Interventions

KetamineDRUG

Ketamine

1
EtomidateDRUG

Etomidate

2

Eligibility Criteria

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

You may qualify if:

  • Patient requiring sedation for prehospital endotracheal intubation
  • Age ≥ 18 years
  • Consent of a family member if present, then of the patient for the pursuit of research

You may not qualify if:

  • Patient in cardiac arrest
  • Presence of contraindication to succinylcholine:
  • Personal or familial history of malignant hyperthermia
  • Known hypersensitivity to succinylcholine
  • Skeletal muscle disease
  • Myasthenia
  • Known hyperkalemia
  • Severe ophthalmic injury
  • Known congenital deficit in plasmatic pseudo-cholinesterase
  • Presence of contraindication to ketamine:
  • Known hypersensitivity to ketamine
  • Known porphyria
  • Severe hypertension
  • Presence of contraindication to etomidate:
  • Known untreated adrenal insufficiency
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Avicenne

Bobigny, 93000, France

Location

Related Publications (2)

  • Jabre P, Combes X, Lapostolle F, Dhaouadi M, Ricard-Hibon A, Vivien B, Bertrand L, Beltramini A, Gamand P, Albizzati S, Perdrizet D, Lebail G, Chollet-Xemard C, Maxime V, Brun-Buisson C, Lefrant JY, Bollaert PE, Megarbane B, Ricard JD, Anguel N, Vicaut E, Adnet F; KETASED Collaborative Study Group. Etomidate versus ketamine for rapid sequence intubation in acutely ill patients: a multicentre randomised controlled trial. Lancet. 2009 Jul 25;374(9686):293-300. doi: 10.1016/S0140-6736(09)60949-1. Epub 2009 Jul 1.

    PMID: 19573904RESULT

  • Wenzel V, Lindner KH. Best pharmacological practice in prehospital intubation. Lancet. 2009 Jul 25;374(9686):267-8. doi: 10.1016/S0140-6736(09)61071-0. Epub 2009 Jul 1. No abstract available.

    PMID: 19573905RESULT

MeSH Terms

Interventions

KetamineEtomidate

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Frederic ADNET, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2007

First Posted

February 26, 2007

Study Start

April 1, 2007

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

September 22, 2011

Record last verified: 2007-05

Locations

FR(1)