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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

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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


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



Primary Outcome Measures :
  1. Day 28 Mortality [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  1. Needs of mechanical ventilation [ Time Frame: Day 28 ]
  2. SOFA Score [ Time Frame: Hour 72 ]
  3. Nosocomial infection [ Time Frame: day 28 ]
  4. Length of stay in ICU [ Time Frame: Day 28 ]
  5. performance status (OMS scale ranging from 0-perfect status- to 4-moribund) [ Time Frame: 6 Months ]


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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

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
Publications of Results:
Other Publications:
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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