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NCT05461521: FAME
Improving FAMily Members' Experience in the ICU
trial testing Family members of patients admitted to the ICU in Stress Disorders, Post-Traumatic in 1,346 participants. Completed in 13 September 2024.
30 January 2024
Quick facts
| Lead sponsor | Nantes University Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,346 |
| Start date | 15 December 2022 |
| Primary completion | 30 January 2024 |
| Estimated completion | 13 September 2024 |
| Sites | 56 locations across Guadeloupe, France |
Drugs / interventions tested
- Family members of patients admitted to the ICU
- Health care professionals
- Patients — full drug profile →
Conditions studied
- Stress Disorders, Post-Traumatic — all drugs for Stress Disorders, Post-Traumatic →
- Family Members — all drugs for Family Members →
Sponsor
Nantes University Hospital
Who can join
18 and older, any sex, with Stress Disorders, Post-Traumatic or Family Members. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the present research is to set up a large multicentric, prospective cohort of family members of patients admitted to intensive care. The data collected will concern the patients and their family members, the caregivers and the functioning of the services during the collection period. This cohort will allow: 1. to carry out a quantitative evaluation of post-traumatic stress disorder (PTSD) in a large number of family members, to determine the risk factors in relation to the characteristics of the family members, and to define a predictive model of PTSD in this population 2. to determine the factors related to the operating conditions of the resuscitation services that favor the occurrence of PTSD in the family members, 3. to create a biological bank from blood samples taken from family members, 4. to carry out a qualitative study allowing a psychological and sociological analysis of the experience of the family members concerning the hospitalization in intensive care of their loved one.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05461521
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Stress Disorders, Post-Traumatic
Currently open trials in the same condition.
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- NCT06852469 — Computational Assessment of GABA Receptor Modulation in PTSD · Phase 4 · recruiting
- NCT06000475 — Enhancing Memory in CPT for PTSD · NA · recruiting
- NCT06355284 — Overcontrol and Suicide in PTSD · active not recruiting
Other Nantes University Hospital trials
Trials by the same sponsor.
- NCT07278661 — Preoperative Use of Romiplostim in Thrombocytopenic Patients Undergoing Cardiac Surgery. · Phase 2 · recruiting
- NCT06681363 — Creation of a Biocollection of Patients With Acute Myeloid Leukemia (AML) or Lymphoid Leukemia (ALL) or High-risk Myelod · not yet recruiting
- NCT07467382 — GOAT (Gait Observation of Achilles Tendon) · not yet recruiting
- NCT07490379 — Comparison of the Efficacy of Transcranial Direct Current Stimulation at Home Versus in Hospital Settings in Patients Wi · NA · not yet recruiting
- NCT07423481 — Weight Trajectories and Predictive Factors After Semaglutide in Patients With Grade 3 and Complicated Obesity · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05461521 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nantes University Hospital
- Last refreshed: 1 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05461521.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing