Evaluation of sedation in intensive therapy

Conditions: adult patients hospitalized in intensive therapy unit undergoing continuous and immediate sedation for at least 24 hours
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Equipment and Supplies [E07]

Registration Number: EUCTR2013-003307-20-IT

Lead Sponsor: ANZIC RESEARCH CENTRE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 4000

Inclusion Criteria

-age over 18 years;
-patient intubated and subjected to mechanical ventilation;
-patient to high likelihood of mechanical ventilation for more than 24 hours (unlikely extubating the following day);
-patient requiring immediate sedation for the management of his/her comfort, security, and to facilitate the intensive treatment
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

-Patient under the age of 18 years;
-Patient intubated for more than 12 hours in an ICU (excluding any operating room time or transport);
-acute injury certain or suspected primary acute brain barrier, such as head trauma, intracranial hemorrhage, brain injury, stroke or hypoxia;
-death is considered imminent or inevitable during hospitalization;

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: improvement in mortality of patients hospitalized in intensive therapy unit mechanically ventilated;Secondary Objective: morbility improvement;Primary end point(s): Improving mortality of ICU patients mechanically ventilated within 90 days and 180 ;Timepoint(s) of evaluation of this end point: 90-180 days

Secondary Outcome Measures