|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02355626 |
|
Date of registration:
|
14/11/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Prognosis of Anxiety in Intensive Care Unit
PAN-ICU |
|
Scientific title:
|
Prognosis of Anxiety in Intensive Care Unit |
|
Date of first enrolment:
|
April 2014 |
|
Target sample size:
|
391 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02355626 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Tarek Sharshar, MD, PHD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
General intensive care unit Raymond Poincaré Hospital, 92380 Garches, France |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- All adult patients admitted to the ICU
- Patient without delirium at admission (assessed using the CAM-ICU score)
Exclusion Criteria:
- Severe hearing impairment or poor understanding of French language
- History of serious psychiatric illness
- Comatose or sedated patient at admission
- Diagnosis of voluntary self-poisoning, or polytrauma at admission
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Anxiety
|
|
Primary Outcome(s)
|
|
Occurrence of death or organ failure.
[Time Frame: 7 days]
|
|
Secondary Outcome(s)
|
|
Assessment of anxiety according to REAX score
[Time Frame: 7 days]
|
|
Assessment of anxiety according to State Trait Anxiety Inventory score (STAI)
[Time Frame: 7 days]
|
|
Assessment of anxiety according to the Visual Analog Scale (VAS)
[Time Frame: 7 days]
|
|
1-Occurrence of shock, delirium, or stress-related complications (upper gastrointestinal bleeding, acute coronary syndrome)
[Time Frame: 7 days]
|
|
Assessment of Geriatric Anxiety Inventory score (GAI)
[Time Frame: 7 days]
|
|
Severity of an ongoing organ failure (maximum SOFA score)
[Time Frame: 7 days]
|
|
Secondary ID(s)
|
|
12-PANICU
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|