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
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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 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
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Procedure: Oxygen therapy only |
- Day 28 Mortality [ Time Frame: Day 28 ]
- 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 ]

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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 |
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

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
France | |
APHP, Hôpital Saint Louis | |
Paris, France, 75010 |
Principal Investigator: | Virginie lemiale, MD | APHP |
Other Publications:
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 |
Respiratory Insufficiency Respiratory Distress Syndrome, Adult Respiration Disorders Respiratory Tract Diseases Lung Diseases |