Acute Respiratory FailureRESIREANCT05193123
Psychological Trauma and Resilience After Critical Illness
An observational study of Acute Respiratory Failure and Shock, run by Nantes University Hospital at 23 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Shock
- How many people
- 200 participants
- Where
- 23 sitesFrance
- Study dates
- 24 Oct 2018to 16 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients included in the NUTRIREA3 study will be contacted by phone calls to complete the quality of life scale (SF-36) 3 and 12 months after inclusion in the trial. Patients included in 24 of the 61 ICUs participating to the NUTRIREA-3 trial will be asked to participate to the RESIREA study at the 3-month phone call, by completing 4 additional questionnaires (IES-R, CD-RISC, MSPSS, B-IPQ), 3 and 12 month after their inclusion in the NUTRIREA-3 trial.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
France23 sites
CHU Amiens Picardie nord
Amiens, 80054
CHU Amiens Picardie sud
Amiens, 80054
CHU Angers
Angers, 49100
CH Angoulême
Angoulême, 16959
CH Annecy Genevois
Annecy, 74374
CH Argenteuil
Argenteuil, 95100
CHU Jean Minjoz
Besançon, 25030
CH de Béthune
Béthune, 62408
CH Chartres Louis Pasteur
Chartres, 26860
CHU Gabriel Montpided
Clermont-Ferrand, 63003
CH Dieppe
Dieppe, 76202
APHP - Hôpital Raymond Poincaré
Garches, 92380
CHD Vendée
La Roche-sur-Yon, 85025
CH du Mans
Le Mans, 72037
CH de Lens
Lens, 62300
CHR- Roger Salengro
Lille, 59037
Hôpital Edouard Herriot
Lyon, 69437
CHU de Nantes
Nantes, 44000
APHP - Hôpital Cochin
Paris, 75014
CH de Bigorre
Tarbes, 65013
CHRU Bretonneau
Tours, 37044
CHU de Valenciennes
Valenciennes, 59300
CHBA - Vannes Auray
Vannes, 56017
About this study
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
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.
Read the detailed 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 :
- Experience of ICU's
- Perception of the disease or/and post intensive care disorders
- Difficulties and capacities of coping
- Difficult events in the patient's life
- Conditions
- Acute Respiratory Failure, Shock
- Keywords
- critical illness, mechanical ventilation, shock, post-traumatic stress disorder, resilience, psychological trauma
- Medical subject headings
- Shock, Critical Illness, Stress Disorders, Post-Traumatic, Psychological Trauma
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with post-traumatic disorders
IES-R scale
Measured: 3 months after ICU stay
Secondary outcomes (5)
Proportion of resilient patients
CD-RISC score > 80
Measured: 3 and 12 months after ICU stay
proportion of patients with impaired Quality of life
SF-36 score
Measured: 3 and 12 months after ICU stay
Proportion of patients with post-traumatic disorders
IES-R
Measured: 12 months after ICU stay
Social support
IES-R
Measured: 3 and 12 months after ICU stay
perception of the disease
MSPSS score
Measured: 3 and 12 months after ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start24 Oct 2018
- Primary completion16 Mar 2021
- Study completion16 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean REIGNIER, PhD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193123
- Sponsor's protocol ID
- MR_Resirea
- Acronym
- RESIREA
- Status last verified
- Dec 2021
- First submitted
- 31 Dec 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05193123
- Acronym / sponsor ID
- RESIREA / MR_Resirea
- Conditions
- Acute Respiratory Failure, Shock
- Keywords
- critical illness, mechanical ventilation, shock, post-traumatic stress disorder, resilience, psychological trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 16 Mar 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 :
- Experience of ICU's
- Perception of the disease or/and post intensive care disorders
- Difficulties and capacities of coping
- Difficult events in the patient's life
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients included in the NUTRIREA3 study will be contacted by phone calls to complete the quality of life scale (SF-36) 3 and 12 months after inclusion in the trial. Patients included in 24 of the 61 ICUs participating to the NUTRIREA-3 trial will be asked to participate to the RESIREA study at the 3-month phone call, by completing 4 additional questionnaires (IES-R, CD-RISC, MSPSS, B-IPQ), 3 and 12 month after their inclusion in the NUTRIREA-3 trial.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with post-traumatic disorders
Time frame: 3 months after ICU stay
IES-R scale
5 secondary outcomes
Proportion of resilient patients
Time frame: 3 and 12 months after ICU stay
proportion of patients with impaired Quality of life
Time frame: 3 and 12 months after ICU stay
Proportion of patients with post-traumatic disorders
Time frame: 12 months after ICU stay
Social support
Time frame: 3 and 12 months after ICU stay
perception of the disease
Time frame: 3 and 12 months after ICU stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean REIGNIER, PhD principal investigator
Nantes University Hospital
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Failure and Shock, run by Nantes University Hospital at 23 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with post-traumatic disorders (time frame: 3 months after ICU stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.