Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure. (IVNICTUS)

Tracking Information
First Submitted Date ICMJE	July 26, 2013
First Posted Date ICMJE	August 5, 2013
Last Update Posted Date	April 18, 2016
Study Start Date ICMJE	August 2013
Actual Primary Completion Date	August 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 2, 2013)	Day 28 Mortality [ Time Frame: Day 28 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01915719 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 2, 2013)	Needs of mechanical ventilation [ Time Frame: Day 28 ]; SOFA Score [ Time Frame: Hour 72 ]; Nosocomial infection [ Time Frame: day 28 ]; Length of stay in ICU [ Time Frame: Day 28 ]; performance status (OMS scale ranging from 0-perfect status- to 4-moribund) [ Time Frame: 6 Months ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure.
Official Title ICMJE	Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure. A Prospective Randomized Clinical Trial.
Brief Summary	Assess the superiority of early non invasive ventilation in comparison to Oxygen therapy only, for immuno-compromized patients with acute respiratory failure
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Adult; Acute Respiratory Failure Admitted in ICU; Immuno Compromized
Intervention ICMJE	Procedure: Early non invasive ventilation; Procedure: Oxygen therapy only
Study Arms	Experimental: Early non invasive ventilation Early non invasive ventilation Intervention: Procedure: Early non invasive ventilation; Active Comparator: Oxygen therapy only Oxygen therapy only Intervention: Procedure: Oxygen therapy only
Publications *	Lemiale V, Resche-Rigon M, Azoulay E; Study Group for Respiratory Intensive Care in Malignancies Groupe de Recherche en Réanimation Respiratoire du patient d’Onco-Hématologie. 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.; Lemiale V, Mokart D, Resche-Rigon M, Pène F, Mayaux J, Faucher E, Nyunga M, Girault C, Perez P, Guitton C, Ekpe K, Kouatchet A, Théodose 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 Réanimation Respiratoire du patient d’Onco-Hématologie (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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: August 2, 2013)	374
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	February 2016
Actual Primary Completion Date	August 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 100 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	France
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01915719
Other Study ID Numbers ICMJE	IVNICTUS
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Assistance Publique - Hôpitaux de Paris
Study Sponsor ICMJE	Assistance Publique - Hôpitaux de Paris
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Virginie lemiale, MD APHP
PRS Account	Assistance Publique - Hôpitaux de Paris
Verification Date	November 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP