Acute respiratory distress syndrome (ARDS) MedDRA version: 21.1 Level: LLT Classification code 10003083 Term: ARDS System Organ Class: 100000004855
Conditions
Interventions
Trade Name: kineret
Product Name: anakinra
Product Code: [L04AC03]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: anakinra
Current Sponsor code: IMP 1
Concentration unit: mg milligra
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA UDINE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age = 18 years; Any gender; Patients admitted to the ICU with a diagnosis of moderate-severe ARDS according to the Berlin criteria and with the need for intubation and mechanical ventilation; Informed consent for participation in the study; Negative swab for COVID-19. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: ¿ Age <18 years; ¿ Pregnant or breastfeeding patients; ¿ Hypersensitivit¿ to the active substance or to any of the excipients or to proteins derived from Escherichia Coli; ¿ Concomitant treatment with anti-TNF-alpha or other biotechnological agent; ¿ Neutropenia (neutrophils <1.5 x 109 / L); ¿ Pre-existing malignant neoplasms; ¿ Moderate to severe renal insufficiency, CL creatinine <60 ml / minute.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate a composite outcome of mortality at 28 days and ventilation-free days. The calculation will take place from the day of extubation to the 28th day of hospitalization. Patients who died prior to respiratory weaning will be considered as having 0 days free of ventilation.;Secondary Objective: The secondary objectives of this study are to evaluate: - Days free from ventilation; - Mortality in IT; - In-hospital mortality; - PaO2 / FiO2 ratio improvement; - Driving pressure reduction; - Reduction of peak pressure; - Reduction of plateau pressure; - Days free from multi-organ damage calculated using Sequential Organ Failure Assessment methodology (SOFA) score (SOFA score <2) on the 28th day or on the last day of hospitalization in the ICU if discharge occurs earlier, or on the death of the patient; - Days free from renal replacement treatment; - Peak blood creatinine; - AST / ALT / bilirubin peak; - Days free from vasoactive support; - Days of hospitalization after discharge from intensive care; - Days of Hospitalization in IT; - Days of hospitalization in hospital; - Cumulative dose of corticosteroids.;Primary end point(s): The primary objective of this study is to evaluate a composite outcome of mortality at 28 days and ventilation-free days. The calculation will take place from the day of extubation to the 28th day of hospitalization. Patients who died prior to respiratory weaning will be considered as having 0 days free of ventilation.;Timepoint(s) of evaluation of this end point: 28 DAYS | — |
Countries
Italy
Contacts
Public ContactClinica di Reumatologia - Azienda O
Azienda Ospedaliero Universitaria Udine
Outcome results
None listed