patients in intensive care unit with invasive mechanical ventilation MedDRA version: 20.0 Level: PT Classification code 10012218 Term: Delirium System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Mélatonine 0.3 mg per day
Pharmaceutical Form: Oral solution
INN or Proposed INN: Melatonine
CAS Number: 73-31-4
Concentra
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age > = 18 years - Patient with invasive mechanical ventilation - Anticipated stay in intensive care unit of at least 48 hours - Informed consent signed by the patient or a trusted person / family member or lack of consent in the event of a life-threatening emergency Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
Exclusion criteria: - Admission in the intensive care unit for more than 48 hours - Pregnancy or breastfeeding - No understanding of the French language, deafness - Dementia (Mini Mental State =5 before or at the time of randomization - Inability to use the enteral route, food intolerance with vomiting - Severe hepatic insufficiency (prothrombin level <30%) - Ongoing treatment with melatonin or drugs that interact with or modify its metabolism (fluvoxamine, 5- or 8-methoxypsoralen, estrogen, cimetidine, carbamazepine, rifampicin) - Dying patient - Patient under tutorship or curatorship - Patient deprived of liberty by judicial or administrative decision - Patient not affiliated to a social security scheme and not a beneficiary of such a scheme - Patient participating in another interventional clinical study with melatonin and / or for whom delirium is the primary endpoint. - Allergy known to melatonin - Patient admitted to intensive care for a cardiorespiratory arrest, stroke, head trauma, neurosurgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the pharmacokinetics and efficacy of melatonin in the prevention of delirium in ventilated patients in the intensive care unit.;Secondary Objective: The secondary objectives are to evaluate the effect of melatonin on morbidity and mortality (duration of ventilation, length of stay, mortality) and sleep, as well as its tolerance; Primary end point(s): The primary endpoint of efficacy (Phase 2) is the proportion of patients who experienced delirium between randomization and D14 (or death or intensive care unit exit if they occur before D14). The primary intermediate endpoint ("activity") for the selection of the most promising experimental arm in the interim analysis is the percentage of patients with an "optimal" pharmacokinetic profile of melatonin 48 hours after initiation of study treatment. ;Timepoint(s) of evaluation of this end point: 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Number of days living without delirium or coma between randomization and J14 - Proportion of days with delirium in intensive care between randomisation and J14 - Duration of mechanical ventilation, number of days living without ventilation between randomisation and J28 - Use of sedative, analgesic and psychotropic treatments between randomization and J14 (or death or intensive care unit exit if they take place before D14). - Clinical evaluation of sleep by the nurse in charge of the patient and the patient himself (if normal consciousness) using the Richards-Campbell score - Length of stay in intensive care unit and hospital - Mortality at D28, in intensive care and at the hospital - Quality of life, anxiety depression, addiction and post traumatic stress at J90 ;Timepoint(s) of evaluation of this end point: 90 days | — |
Countries
France
Contacts
Public ContactDRCI Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed