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Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning (Sevralox)

This study is currently recruiting participants.
Verified July 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01193816
First received: August 26, 2010
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

This study aims to assess the efficacy of a drug (loxapine, a neuroleptic) in calming patients down in a situation of restlessness during mechanical ventilation weaning. This drug is used for several years to quieten restless patients. Its purpose is to restore spontaneous breathing sooner and therefore to reduce the risks of intubation and mechanical ventilation.


Condition Intervention Phase
Restlessness
 Drug: loxapine
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Weaning period [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
    Weaning period (days) between inclusion (ie first administration of loxapine/placebo) and successful extubation (no re-intubation in the following 48 hours)


Secondary Outcome Measures:
  • total duration of mechanical ventilation [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
    -number of days of mechanical ventilation

  • incidence of unexpected extubations [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
    number of patients with unexpected extubation

  • clinical and biological respiratory parameters [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    description of abnormal clinical and biological respiratory parameters, number of patients concerned.

  • incidence of mechanical ventilation related complications [ Time Frame: up to 48 hours after extubation ] [ Designated as safety issue: No ]
    collapses, nosocomial pneumonia, respiratory issue requiring an increase of FiO2 and/or PEP.

  • incidence of adverse events, related and non related to the treatment [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]
  • mortality rate [ Time Frame: day 14 and week 6 ] [ Designated as safety issue: No ]
    mortality rate at day 14 and week 6

  • factors associated to weaning failure [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
    age, patient medical history,duration of sedation or ventilation, weaning failure


Estimated Enrollment: 300
Study Start Date: May 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: loxapine
loxapine
 Drug: loxapine
Each patient may receive a maximum dosage of 900mg of Loxapine per day (drinkable solution through gastric probe) or the same volume of placebo. 2 initial administrations of 150 mg followed by potential readministration of 100 mg of loxapine. Maximum duration of treatment will be 14 days.The dosage by day is defined by patients' clinical condition, assessed with RASS score.
Other Name: loxapine
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo
Other Name: Placebo

Detailed Description:

This study aims to assess the efficacy of a drug (loxapine, a neuroleptic) in calming patients down in a situation of restlessness during mechanical ventilation weaning. This drug is used for several years to quieten restless patients. Its purpose is to restore spontaneous breathing sooner and therefore to reduce the risks of intubation and mechanical ventilation. 300 patients will participate in the study and will be randomized, after informed consent, to receive either loxapine or a placebo.Patients whose proxies refuse participation will be sedated according to standard care procedures.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥ 18 years,
  • sedated
  • under mechanical ventilation through intubation probe for more than 48 hours
  • no contra-indication to naso-gastric probe- with criteria for potential weaning
  • with social security
  • important restlessness at sedation withdrawal, defined as RASS score (Richmond Agitation Sedation Scale)= 2. This restlessness has no potential danger for the patient but requires a level of sedation. This re-sedation implies administration of morphinomimetics and benzodiazepines at dosages that does not allow to pursue mechanical ventilation weaning attempts.

Exclusion Criteria:

  • extreme restlessness at sedation withdrawal ((RASS>2)
  • allergy to loxapine or one of its component
  • dopaminergic agonists
  • extubation planned in the following 24 hours
  • antecedent of comitiality
  • known pregnancy at admission
  • proxies opposed to study participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193816

Contacts
Contact: Didier Dreyfuss, MD +33 1 47 60 61 93 didier.dreyfuss@lmr.aphp.fr

Locations
France
Hôpital Louis Mourier Recruiting
Colombes, France
Contact: Didier Dreyfuss, MD     +33 1 47 60 6193     dider.dreyfuss@lmr.aphp.fr    
Contact: Laurence Salomon,, MD     +33(0) 1 47 60 67 27     laurence.salomon@lmr.aphp.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Didier Dreyfuss, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01193816     History of Changes
Other Study ID Numbers: P 070106
Study First Received: August 26, 2010
Last Updated: July 25, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
restlessness during mechanical ventilation weaning

Additional relevant MeSH terms:
Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Loxapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013