Clinical trial NCT01915719: Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure.
Official title: Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure. A Prospective Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult
Acute Respiratory Failure Admitted in ICU
Immuno Compromized
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assess the superiority of early non invasive ventilation in comparison to Oxygen therapy only, for immuno-compromized patients with acute respiratory failure


Eligibility criteria: Inclusion Criteria:

* Age over 18 years old
* ICU admission
* Acute respiratory failure defined by (PaO2\<60 mmHg at room air) or (polypnea \>30/min or dyspnea at rest) or respiratory distress. Since less than 72 hours.
* Immuno compromized patient defined by solid tumor (treated since less than 5 years) or haematological malignancy (treated since less than 5 years) or Solid organ transplantation or Stem cell transplantation or Immunosuppressive treatment (steroid \> 1mg/kg/d or \>1 month or other immunosuppressive treatment \>1 month)

Exclusion Criteria:

* Hypercapnia \>50 mmHg or increased of hypercapnia \>10 mmHg under Oxygen treatment
* Need of immediate mechanical ventilation
* Obvious cardiogenic oedema
* Vasopressor use \>0.03 µg/kg/min
* Glasgow Score \<13
* End of life decision
* Acute myocardial infarction
* Patient refusal
* Pregnancy
* No national health insurance

Primary outcomes:
measure: Day 28 Mortality
timeFrame: Day 28
Secondary outcomes:
measure: Needs of mechanical ventilation
timeFrame: Day 28
measure: SOFA Score
timeFrame: Hour 72
measure: Nosocomial infection
timeFrame: day 28
measure: Length of stay in ICU
timeFrame: Day 28
measure: performance status (OMS scale ranging from 0-perfect status- to 4-moribund)
timeFrame: 6 Months
Other outcomes:
Locations:
city: Paris
country: France
facility: APHP, Hôpital Saint Louis
Study officials:
affiliation: APHP
name: Virginie lemiale, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lemiale V, Resche-Rigon M, Azoulay E; Study Group for Respiratory Intensive Care in Malignancies Groupe de Recherche en Reanimation Respiratoire du patient d'Onco-Hematologie. Early non-invasive ventilation for acute respiratory failure in immunocompromised patients (IVNIctus): study protocol for a multicenter randomized controlled trial. Trials. 2014 Sep 25;15:372. doi: 10.1186/1745-6215-15-372.
citation: Lemiale V, Mokart D, Resche-Rigon M, Pene F, Mayaux J, Faucher E, Nyunga M, Girault C, Perez P, Guitton C, Ekpe K, Kouatchet A, Theodose I, Benoit D, Canet E, Barbier F, Rabbat A, Bruneel F, Vincent F, Klouche K, Loay K, Mariotte E, Bouadma L, Moreau AS, Seguin A, Meert AP, Reignier J, Papazian L, Mehzari I, Cohen Y, Schenck M, Hamidfar R, Darmon M, Demoule A, Chevret S, Azoulay E; Groupe de Recherche en Reanimation Respiratoire du patient d'Onco-Hematologie (GRRR-OH). Effect of Noninvasive Ventilation vs Oxygen Therapy on Mortality Among Immunocompromised Patients With Acute Respiratory Failure: A Randomized Clinical Trial. JAMA. 2015 Oct 27;314(16):1711-9. doi: 10.1001/jama.2015.12402.