Psychological Trauma and Resilience After Critical Illness

Acute Respiratory Failure Clinical Trial

— RESIREA  

Official title:

Psychological Trauma and Resilience After ICU Stay in Patients Treated With Mechanical Ventilation for Severe Critical Illness: the Multicenter, Prospective, Observational RESIREA Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05193123
• Other study ID #: MR_Resirea
• Status: Completed
• Start date: October 24, 2018
• Est. completion date: December 16, 2021

Study information

• Verified date: December 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Critically ill patients experience a severe physical disease, associated with a psychotrauma, which may lead to post-traumatic stress disorder (17 to 30% of patients after critical illness) and persistent symptoms of anxiety and depression. RESIREA study will study psychodrama, resilience and factors associated with resilience in patients previously included in the NUTRIREA-3 randomized controlled trial designed to compare standard calorie and protein feeding complying with guidelines to low-calorie low-protein feeding in a well-defined group of severely ill ICU patients requiring at least MV and vasoactive drugs.

Description:

Social demographic data (gender, age, marital status, psychological information and medical background) and medical data (severity of the disease, duration of ICU stay, SOFA score) will be collected, as for the NUTRIREA-3 trial. Before leaving the ICU, patient who agreed to participate to the NUTRIREA 3 study were asked to participate to the RESIREA study. Patients will be called by phone by a psychologist 3 months after their inclusion in the NUTRIREA-3 trial to complete the SF-36 score. Then, they will be asked to confirm their participation to the RESIREA study by completing four additional questionnaires (post-trauma stress disorder: IES-R; Resilience: CD-RISC; Social support: MSPSS; Perception of the disease: B-IPQ). If the patient does not respond to the phone call at the first time, he/she will be contacted again within a period of 2 weeks maximum (1 call/day). If the patient remains unreachable, he/she will be considered as lost for the study. Patients will be called again 12 months after their inclusion in the NUTRIREA-3 trial and will be asked to complete the five questionnaires (SF-36, IES-R, CD-RISC, MSPSS and B-IPQ). During this last phone call, 40 patients will be asked to a third interview by phone. These patients will be spotted thanks to their score at the IES-R and CD-RISC. This interview of 30 to 45 minutes will be planned within 15 days after the T12 call and recorded. This semi structured interview will be lead by an experienced clinical psychologist and follow 4 main topics : 1. Experience of ICU's 2. Perception of the disease or/and post intensive care disorders 3. Difficulties and capacities of coping 4. Difficult events in the patient's life

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 16, 2021
• Est. primary completion date: March 16, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Invasive mechanical ventilation started within the past 24 h, or started before ICU admission with ICU admission within the past 24 h, for an expected duration of at least 48 hours after inclusion
• Treatment with vasoactive agent for shock (adrenaline, dobutamine, or noradrenaline)
• Nutritional support expected to be started within 24 h after intubation
• Age older than 18 years
• Informed consent to participation in the study

Exclusion Criteria:

• Invasive mechanical ventilation started more than 24 hours earlier
• Specific nutritional needs, such as pre-existing long-term home enteral or parenteral nutrition, or for chronic bowel disease
• Dying patient, not-to-be-resuscitated order, or other treatment limitation decision at ICU admission
• Pregnancy, recent delivery, or lactation

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Critical Illness
• Psychological Trauma
• Respiratory Insufficiency
• Shock

Locations

Country	Name	City	State
France	CHU Amiens Picardie nord	Amiens
France	CHU Amiens Picardie sud	Amiens
France	CHU Angers	Angers
France	CH Angoulême	Angoulême
France	CH Annecy Genevois	Annecy
France	CH Argenteuil	Argenteuil
France	CHU Jean Minjoz	Besançon
France	CH de Béthune	Béthune
France	CH Chartres Louis Pasteur	Chartres
France	CHU Gabriel Montpided	Clermont-Ferrand
France	CH Dieppe	Dieppe
France	APHP - Hôpital Raymond Poincaré	Garches
France	CHD Vendée	La Roche-sur-Yon
France	CH du Mans	Le Mans
France	CH de Lens	Lens
France	CHR- Roger Salengro	Lille
France	Hôpital Edouard Herriot	Lyon
France	CHU de Nantes	Nantes
France	APHP - Hôpital Cochin	Paris
France	CH de Bigorre	Tarbes
France	CHRU Bretonneau	Tours
France	CHU de Valenciennes	Valenciennes
France	CHBA - Vannes Auray	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with post-traumatic disorders	IES-R scale	3 months after ICU stay
Secondary	Proportion of resilient patients	CD-RISC score > 80	3 and 12 months after ICU stay
Secondary	proportion of patients with impaired Quality of life	SF-36 score	3 and 12 months after ICU stay
Secondary	Proportion of patients with post-traumatic disorders	IES-R	12 months after ICU stay
Secondary	Social support	IES-R	3 and 12 months after ICU stay
Secondary	perception of the disease	MSPSS score	3 and 12 months after ICU stay