Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning (Sevralox)
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|ClinicalTrials.gov Identifier: NCT01193816|
Recruitment Status : Completed
First Posted : September 2, 2010
Last Update Posted : July 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Restlessness||Drug: loxapine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Assessment of Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||July 2014|
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.
Placebo Comparator: Placebo
- Weaning period [ Time Frame: up to 28 days ]Weaning period (days) between inclusion (ie first administration of loxapine/placebo) and successful extubation (no re-intubation in the following 48 hours)
- total duration of mechanical ventilation [ Time Frame: up to 28 days ]-number of days of mechanical ventilation
- incidence of unexpected extubations [ Time Frame: up to 28 days ]number of patients with unexpected extubation
- clinical and biological respiratory parameters [ Time Frame: 24 hours ]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 ]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 ]
- mortality rate [ Time Frame: day 14 and week 6 ]mortality rate at day 14 and week 6
- factors associated to weaning failure [ Time Frame: up to 28 days ]age, patient medical history,duration of sedation or ventilation, weaning failure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193816
|Hôpital Louis Mourier|
|Principal Investigator:||Didier Dreyfuss, MD||Assistance Publique - Hôpitaux de Paris|