NCT01915719

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
374

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 18, 2016

Status Verified

November 1, 2015

Enrollment Period

2 years

First QC Date

July 26, 2013

Last Update Submit

April 15, 2016

Conditions

AdultAcute Respiratory Failure Admitted in ICUImmuno Compromized

Outcome Measures

Primary Outcomes (1)

  • Day 28 Mortality

    Day 28

Secondary Outcomes (5)

  • Needs of mechanical ventilation

    Day 28

  • SOFA Score

    Hour 72

  • Nosocomial infection

    day 28

  • Length of stay in ICU

    Day 28

  • performance status (OMS scale ranging from 0-perfect status- to 4-moribund)

    6 Months

Study Arms (2)

Early non invasive ventilation

EXPERIMENTAL

Early non invasive ventilation

Procedure: Early non invasive ventilation

Oxygen therapy only

ACTIVE COMPARATOR

Oxygen therapy only

Procedure: Oxygen therapy only

Interventions

Early non invasive ventilationPROCEDURE
Early non invasive ventilation
Oxygen therapy onlyPROCEDURE
Oxygen therapy only

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APHP, Hôpital Saint Louis

Paris, 75010, France

Location

Related Publications (2)

  • 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.

    PMID: 25257210BACKGROUND

  • 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.

    PMID: 26444879RESULT

Study Officials

  • Virginie lemiale, MD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2013

First Posted

August 5, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2015

Study Completion

February 1, 2016

Last Updated

April 18, 2016

Record last verified: 2015-11

Locations

FR(1)