CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029, France
NCT Number: NCT01838798
This is a prospective, single-center, pilot, cohort study. The first phase of this study is observational and the usual care of patients is maintained during the ICU stay, except for an interview with a psychologist preceding patient discharge. A phone interview at 2 months and a visit with a psychologist at four months after ICU discharge are specific to the study.
The main objective of this study is to make a first estimate of the percentage of patients (CI = +- 10%) with cognitive impairment at four months after ICU discharge. The presence / absence of cognitive impairment will be determined by the D2 test.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Nîmes, 30029, France
The secondary objectives of this study are:
A. To study the potential links between cognitive impairment and quality of life 4 months after discharge from the Intensive Care Unit.
B. To study the associations between variables measured during hospitalization. Is there "clustering" among certain symptoms during hospitalization?
C. To study the associations between variables measured at two and four months after ICU discharge. Is there clustering among these symptoms?
D. To study potential risk factors for cognitive problems at 4 months after ICU discharge.
E. If objective C determines the presence of clusters, is the presence / absence of these clusters related to the variables (or clusters of variables) measured during hospitalization?
F. To study potential risk factors for poor quality of life at 4 months:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Initial consent procedures and baseline data collection.
Clinical interview with a psychologist.
This interview with a psychologist will take place after patient consent procedures, and at least 2 days after discontinuation of sedation, and before leaving the ICU. This interview will include:
At 2 months after leaving the ICU, a psychologist will contact the patient with questions regarding his/her representation of hospitalization. This implies the following:
Time frame: 4 months after ICU discharge
based on D2 test
Time frame: expected average of 48 hours
Time frame: expected average of 36 hours
Time frame: Expected maximum of 28 days
Time frame: expected average of 48 hours
Time frame: upon awakening (expected average of 48 hours)
Time frame: expected average of 5 days (end of ICU stay)
Time frame: expected average of 5 days (end of ICU stay)
Time frame: expected average of 5 days (end of ICU stay)
Time frame: expected average of 5 days (end of ICU stay)
Time frame: 60 +- 3 days after ICU discharge
Time frame: 60 +- 3 days after ICU discharge
Time frame: 60 +- 3 days after ICU discharge
Time frame: 60 +- 3 days after ICU discharge
Time frame: 4 months after ICU discharge
Time frame: 4 months after ICU discharge
Time frame: 4 months after ICU discharge
Time frame: 4 months after ICU discharge
Time frame: 4 months after ICU discharge
Time frame: 4 months after ICU discharge
Time frame: 4 months after ICU discharge
Time frame: 4 months after ICU discharge
Time frame: 4 months after ICU discharge
Time frame: 4 months after ICU discharge
Centre Hospitalier Universitaire de Nīmes
Other
Acronym: NeuroPsy Réa
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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