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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

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
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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  ICMJE
  • 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 *

*   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  ICMJE 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE 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