An interventional study of Diary in Sudden Death and Sudden Cardiac Arrest, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Supportive care
Sudden death is a public health problem with more than 300,000 cases per year in USA and 40,000 cases per year in France. Moreover, despite all recent therapeutic improvements (therapeutic hypothermia, new techniques of resuscitation…), the prognosis remains drastically poor and less than 50% of the patients admitted alive at hospital will survive to the event at 1 year.
Outside all medications and technical care to improve patient prognosis, a psychological evaluation looks also critical to detect the occurrence of a "post traumatic stress syndrome". In fact, along with the event severity, a variable period of amnesia related to coma may favor the occurrence of such a syndrome and psychological issues, which at the end may lead to impairment of patient quality of life.
Previous studies have evaluated the impact of an intensive care unit diary on psychological distress in patients and relatives in the context of severe traumatisms. Such an evaluation has however never been done in the specific setting of sudden death and the frequency of this syndrome is unknown in this context.
Aim The aim of the present study is to evaluate the impact of an intensive care unit diary on the occurrence of a "post traumatic stress syndrome" after a sudden death.
Secondary objectives
The COREABOR Study is an open label, prospective, that will compare patients with sudden death who will be included during 2 successive periods of time: first a period of control and then a period of intervention.
Interventional study.
Altogether, 330 patients with resuscitated sudden death will be screened during the whole study period allowing to include 96 patients in the study (alive at 3 months after the event, estimated survival rate of 30%). For each screened patient, 2 relatives will be selected to participate to the study (n=660).
To avoid biases, the control group of 48 patients will be included first and treated as recommended with usual care in center. Then, the 48 patients of the intervention group will be included during the second period of the study and the intensive care unit diary will be implemented only at this time.
In the intervention group (second period with diary), a maximal delay of 8 hours is allowed to implement the diary for each patient after admission in centre.
Visit 0 (V0): inclusion The study will recruit patients in the total incapacity to give their own consent for medical reasons (comatose patients) at admission. Subsequently a written inform consent of a relative will first be obtained and the patient's written consent will be obtained as soon as possible afterwards.
Period 1: control group Medical care as usually performed in center and as recommended.
Period 2: intervention group (intensive care unit diary) On top of usual care, an intensive care unit diary will be implemented for all patients within the first 8 hours following their admission. At discharge, the diary will be given to the patients themselves or to their relatives in case of in-hospital death. An anonymous copy will be kept by investigators.
For all patients A psychological evaluation will be performed at 1 month (V1), 3 months (V2) and 6 months by phone contact only (V3) using the following elements Auto-questioner (PDI) Nurse diagnosis Psychological evaluation by dedicated personal (CAPS and mini-DSMIV)
For relatives A psychological evaluation will be performed at 3 months (V2) and 6 months by phone contact only (V3)
66 studies on the registry are indexed under Death, Sudden; 5 are open to participants now.
This study's enrollment of 173 is close to the median of 168 across 28 interventional studies indexed under Death, Sudden.
Browse Death, Sudden studies →University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.
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Relative's inclusion criteria :
Exclusion Criteria =
Patient's non-inclusion criteria :
Relative's non-inclusion criteria :
Patients treated as recommended with usual care in a center.
Intervention group = On top of usual care, an intensive care unit diary will be implemented for patients within the first 8 hours following their admission.
Other: Diary
The diary was specifically created for the purpose of the present study by personal working at ICU at CHRU of Lille (France). All relatives, doctors and paramedics close to the patient during his hospital stay are allowed to write some comments inside the diary when he is comatose. The diary will be implemented during the second period of the study within the first 8 hours after admission. It will be given to the patients themselves at discharge or to their relatives in case of in-hospital death. An anonymous copy will be kept by investigators.
Rate of occurrence of "post traumatic stress disorder"
Rate of occurrence of "post traumatic stress syndrome" (CAPS score over 39) at 3 months after resuscitation after sudden death
Time frame: 3 months
Peritraumatic Distress Inventory (PDI) Scale
PDI is a scale of self-evaluation of 13 items to determine distress reactions emotional of a person at the time of a traumatic event and in the minutes and hours. People who have a high risk of distress Peritraumatic develop post-traumatic stress disorder.
Time frame: 1 month
Psychiatric comorbidities
Psychiatric comorbidities evaluated by the mini DSM IV (Diagnostic and Statistical Manual of Mental Disorders - IV) for patients
Time frame: 3 and 6 months
Rate of "Post traumatic stress disorder" for patients
Rate of "Post traumatic stress disorder" (CAPS score over 39) for patients
Time frame: 6 months
Rate of "Post traumatic stress disorder" for relatives
Rate of "Post traumatic stress disorder" (CAPS score over 39) for relatives
Time frame: 3 and 6 months
Nurse diagnosis
Comparison of nurse diagnosis and diagnosis made by dedicated personal with a specific formation in psychology
Time frame: 3 months
Qualitative evaluation of the diary
Qualitative evaluation of the diary by satisfaction questionnaire
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2014 to primary completion in Dec 2023, 108 months.
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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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