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

Primary Purpose

Adult, Acute Respiratory Failure Admitted in ICU, Immuno Compromized

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Early non invasive ventilation
Oxygen therapy only
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • APHP, Hôpital Saint Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early non invasive ventilation

Oxygen therapy only

Arm Description

Early non invasive ventilation

Oxygen therapy only

Outcomes

Primary Outcome Measures

Day 28 Mortality

Secondary Outcome Measures

Needs of mechanical ventilation
SOFA Score
Nosocomial infection
Length of stay in ICU
performance status (OMS scale ranging from 0-perfect status- to 4-moribund)

Full Information

First Posted
July 26, 2013
Last Updated
April 15, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01915719
Brief Title
Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure.
Acronym
IVNICTUS
Official Title
Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure. A Prospective Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult, Acute Respiratory Failure Admitted in ICU, Immuno Compromized

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
374 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early non invasive ventilation
Arm Type
Experimental
Arm Description
Early non invasive ventilation
Arm Title
Oxygen therapy only
Arm Type
Active Comparator
Arm Description
Oxygen therapy only
Intervention Type
Procedure
Intervention Name(s)
Early non invasive ventilation
Intervention Type
Procedure
Intervention Name(s)
Oxygen therapy only
Primary Outcome Measure Information:
Title
Day 28 Mortality
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Needs of mechanical ventilation
Time Frame
Day 28
Title
SOFA Score
Time Frame
Hour 72
Title
Nosocomial infection
Time Frame
day 28
Title
Length of stay in ICU
Time Frame
Day 28
Title
performance status (OMS scale ranging from 0-perfect status- to 4-moribund)
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginie lemiale, MD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
APHP, Hôpital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25257210
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.
Results Reference
background
PubMed Identifier
26444879
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.
Results Reference
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Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure.

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