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

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ClinicalTrials.gov Identifier: NCT01915719

Recruitment Status : Completed

First Posted : August 5, 2013

Last Update Posted : April 18, 2016

Sponsor:

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Adult Acute Respiratory Failure Admitted in ICU Immuno Compromized	Procedure: Early non invasive ventilation Procedure: Oxygen therapy only	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	374 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure. A Prospective Randomized Clinical Trial.
Study Start Date :	August 2013
Actual Primary Completion Date :	August 2015
Actual Study Completion Date :	February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Respiratory Failure

Genetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Early non invasive ventilation Early non invasive ventilation	Procedure: Early non invasive ventilation
Active Comparator: Oxygen therapy only Oxygen therapy only	Procedure: Oxygen therapy only

Outcome Measures

Primary Outcome Measures :

Day 28 Mortality [ Time Frame: Day 28 ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 100 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915719

Locations

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France
APHP, Hôpital Saint Louis
Paris, France, 75010

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

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Principal Investigator:	Virginie lemiale, MD	APHP

More Information

Publications of Results:

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.

Other 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.

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Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT01915719
Other Study ID Numbers:	IVNICTUS
First Posted:	August 5, 2013 Key Record Dates
Last Update Posted:	April 18, 2016
Last Verified:	November 2015

Additional relevant MeSH terms:

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Respiratory Insufficiency Respiratory Distress Syndrome, Adult Respiration Disorders Respiratory Tract Diseases Lung Diseases

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