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

• ClinicalTrials.gov Identifier: NCT01915719
• Recruitment Status: Completed
• First Posted: August 5, 2013
• Last Update Posted: April 18, 2016
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

Tracking Information

• First Submitted Date: July 26, 2013
• First Posted Date: August 5, 2013
• Last Update Posted Date: April 18, 2016
• Study Start Date: August 2013
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 2, 2013): Day 28 Mortality [ Time Frame: Day 28 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Adult
• Acute Respiratory Failure Admitted in ICU
• Immuno Compromized

Intervention

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 2, 2013): 374
• Original Estimated Enrollment: 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

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, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01915719
• Other Study ID Numbers: 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: Assistance Publique - Hôpitaux de Paris
• Collaborators: Not Provided

Investigators

• Principal Investigator: Virginie lemiale, MD; APHP

• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: November 2015