Patients Admitted to ICU with proven or suspected infection as the main diagnosis

Phase 1

• Conditions: Patients admitted to the ICU proven or suspected infection as the main diagnosis.; MedDRA version: 20.0Level: LLTClassification code 10040050Term: Sepsis NOSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2020-000296-21-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-11
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

1) Patients = 18 years old,
2) Admitted to the ICU with proven or suspected infection as the main diagnosis,
3) Community acquired pneumonia related sepsis OR vasopressors dependency (norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine) OR septic shock (Singer 2016: vasopressor to maintain mean blood pressure of at least 65 mmHg and lactate levels above 2 mmol/l) OR acute respiratory distress syndrome (ARDS – Ranieri 2012: a- acute onset, i.e. within one week of an apparent clinical insult and with progression of respiratory syndrome, b- bilateral opacities on chest imaging not explained by other pulmonary pathologies, e.g. pleural effusion, atelectasis, nodules etc, c- no evidence for heart failure or volume overload, d- PaO2/FiO2 = 300 mm Hg, - PEEP = 5 cm H2O
4) Patient who has signed an informed and written consent whevener he/she is able of consent, if not ascent from his/her representant whenever he/she is present at time of screening for inclusion
5) Patients who have been tested for RECORDS specific biomarkers
oCIRCI negative
oEndocan < 2 ng/L
oGILZ < x (threshold currently under study)
oCPD positive
oTranscriptomic SRS2
oEndotype B
6) Affiliation to a social security system or to an universal health coverage (Couverture Maladie Universelle, CMU);
7) Patients under guardianship or curatorship will be included;
8) Patients in case of simple emergency (legal definition) will be included.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 900
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 900

Exclusion Criteria

1) Pregnancy
2) Expected death or withdrawal of life-sustaining treatments within 48 hours
3) Previously enrolled in this study or in an other ineterventional study,
4) Hypersensitivity to hydrocortisone or fludrocortisone or any of their excipients ( SPC),
5) Women of childbearing potential not using contraception,
6) Nursing women.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified