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

Primary Purpose

Restlessness

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
loxapine
Placebo
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Restlessness focused on measuring restlessness during mechanical ventilation weaning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Louis Mourier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

loxapine

Placebo

Arm Description

loxapine

Placebo

Outcomes

Primary Outcome Measures

Weaning period
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
-number of days of mechanical ventilation
incidence of unexpected extubations
number of patients with unexpected extubation
clinical and biological respiratory parameters
description of abnormal clinical and biological respiratory parameters, number of patients concerned.
incidence of mechanical ventilation related complications
collapses, nosocomial pneumonia, respiratory issue requiring an increase of FiO2 and/or PEP.
incidence of adverse events, related and non related to the treatment
mortality rate
mortality rate at day 14 and week 6
factors associated to weaning failure
age, patient medical history,duration of sedation or ventilation, weaning failure

Full Information

First Posted
August 26, 2010
Last Updated
July 17, 2014
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01193816
Brief Title
Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning
Acronym
Sevralox
Official Title
Assessment of Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restlessness
Keywords
restlessness during mechanical ventilation weaning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
loxapine
Arm Type
Experimental
Arm Description
loxapine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
loxapine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Weaning period
Description
Weaning period (days) between inclusion (ie first administration of loxapine/placebo) and successful extubation (no re-intubation in the following 48 hours)
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
total duration of mechanical ventilation
Description
-number of days of mechanical ventilation
Time Frame
up to 28 days
Title
incidence of unexpected extubations
Description
number of patients with unexpected extubation
Time Frame
up to 28 days
Title
clinical and biological respiratory parameters
Description
description of abnormal clinical and biological respiratory parameters, number of patients concerned.
Time Frame
24 hours
Title
incidence of mechanical ventilation related complications
Description
collapses, nosocomial pneumonia, respiratory issue requiring an increase of FiO2 and/or PEP.
Time Frame
up to 48 hours after extubation
Title
incidence of adverse events, related and non related to the treatment
Time Frame
up to 28 days
Title
mortality rate
Description
mortality rate at day 14 and week 6
Time Frame
day 14 and week 6
Title
factors associated to weaning failure
Description
age, patient medical history,duration of sedation or ventilation, weaning failure
Time Frame
up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Dreyfuss, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Louis Mourier
City
Colombes
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28877705
Citation
Gaudry S, Sztrymf B, Sonneville R, Megarbane B, Van Der Meersch G, Vodovar D, Cohen Y, Ricard JD, Hajage D, Salomon L, Dreyfuss D. Loxapine to control agitation during weaning from mechanical ventilation. Crit Care. 2017 Sep 6;21(1):235. doi: 10.1186/s13054-017-1822-y.
Results Reference
derived

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Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning

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