Therapeutic plasma exchange, rituximab and intravenous immunoglobulins (IVIg) for severe acute exacerbation of idiopathic pulmonary fibrosis admitted in ICU: an open, randomized, controlled trial - EXCHANGE-IFP

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 40 人开始时间: 2018年7月20日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•1.Patient = 18 years of age and < 75 years
•2.Admitted to ICU in the last 72 h
•3.Definite or probable IPF diagnosis defined on 2011 ATS/ERS/JRS/ALAT guidelines or a possible usual interstitial pneumonia pattern on HRCT without etiology.
•4.Definite AE-IPF according to the 2016 revised criteria :
•a) Previous or concurrent diagnosis of idiopathic pulmonary fibrosis (if the diagnosis of IPF is not previously established, this criterion can be met by the presence of radiologic and or histopathologic changes consistent with usual interstitial pneumonia (UIP) pattern on the current evaluation);
•b) Acute worsening or development of dyspnea typically of less than one-month duration;
•c) Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with a UIP pattern (if no previous computed tomography is available, the qualifier new” can be dropped);
•d) Deterioration not fully explained by cardiac failure or fluid overload.
•5.PaO2/FiO2 ratio < 200
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1.Known hypersensitivity intravenous immunoglobulins or rituximab
•2.Severe heart failure
•3.Active and uncontrolled bacterial fungal or parasitic infection
•4.Positive multiplex PCR for Influenzae A and B, and for VRS
•5.Deep Veinous Thrombosis or Pulmonary embolism in the last six months
•6.Prior exposures to human-murine chimeric antibodies
•7.Ongoing treatment with a cellular immunosuppressant (e.g., cyclophosphamide, methotrexate, mycophenolate, azathioprine, calcineurin inhibitors, etc.)
•8.Subject treated with more than 2 boluses of methylprednisolone (total dose > 500mg of methylprednisolone) or one dose > 10mg/kg in the last 72 hours
•9.Uncorrectable coagulopathies or thrombocytopenia < 30000/mm3
•10.Active cancer (other than basal cell carcinoma of the skin)
•11.Other source of immunosuppression (i.e. HIV infection, solid organ transplant, lymphoma or leukemia)
•12.Pregnancy
•13.Patient listed for lung transplantation
•14.Patient on ECMO
•15.Patient with a do-not-intubate order at admission to ICU
•16.Concurrent participation in other experimental trials
•17.Not Affiliation to the French social security
•18.Not Written informed consent from the patient or a legal representative if appropriate

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