NCT05193123

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 31, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
Last Updated

January 14, 2022

Status Verified

December 1, 2021

Enrollment Period

2.4 years

First QC Date

December 31, 2021

Last Update Submit

December 31, 2021

Conditions

Acute Respiratory FailureShock

Keywords

critical illnessmechanical ventilationshockpost-traumatic stress disorderresiliencepsychological trauma

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with post-traumatic disorders

    IES-R scale

    3 months after ICU stay

Secondary Outcomes (5)

  • Proportion of resilient patients

    3 and 12 months after ICU stay

  • proportion of patients with impaired Quality of life

    3 and 12 months after ICU stay

  • Proportion of patients with post-traumatic disorders

    12 months after ICU stay

  • Social support

    3 and 12 months after ICU stay

  • perception of the disease

    3 and 12 months after ICU stay

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

CHU Amiens Picardie nord

Amiens, 80054, France

Location

CHU Amiens Picardie sud

Amiens, 80054, France

Location

CHU Angers

Angers, 49100, France

Location

CH Angoulême

Angoulême, 16959, France

Location

CH Annecy Genevois

Annecy, 74374, France

Location

CH Argenteuil

Argenteuil, 95100, France

Location

CHU Jean Minjoz

Besançon, 25030, France

Location

CH de Béthune

Béthune, 62408, France

Location

CH Chartres Louis Pasteur

Chartres, 26860, France

Location

CHU Gabriel Montpided

Clermont-Ferrand, 63003, France

Location

CH Dieppe

Dieppe, 76202, France

Location

APHP - Hôpital Raymond Poincaré

Garches, 92380, France

Location

CHD Vendée

La Roche-sur-Yon, 85025, France

Location

CH du Mans

Le Mans, 72037, France

Location

CH de Lens

Lens, 62300, France

Location

CHR- Roger Salengro

Lille, 59037, France

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

CHU de Nantes

Nantes, 44000, France

Location

APHP - Hôpital Cochin

Paris, 75014, France

Location

CH de Bigorre

Tarbes, 65013, France

Location

CHRU Bretonneau

Tours, 37044, France

Location

CHU de Valenciennes

Valenciennes, 59300, France

Location

CHBA - Vannes Auray

Vannes, 56017, France

Location

MeSH Terms

Conditions

ShockCritical IllnessStress Disorders, Post-TraumaticPsychological Trauma

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Jean REIGNIER, PhD

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2021

First Posted

January 14, 2022

Study Start

October 24, 2018

Primary Completion

March 16, 2021

Study Completion

December 16, 2021

Last Updated

January 14, 2022

Record last verified: 2021-12

Locations

FR(23)