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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT01915719

First received: July 26, 2013

Last updated: April 15, 2016

Last verified: November 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

July 26, 2013

Last Updated Date

April 15, 2016

Start Date ^ICMJE

August 2013

Primary Completion Date

August 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Day 28 Mortality [ Time Frame: Day 28 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01915719 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Not Provided

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

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

Enrollment ^ICMJE

374

Completion Date

February 2016

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

Sexes Eligible for Study:

All

Ages

18 Years to 100 Years (Adult, Senior)

Accepts Healthy Volunteers

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

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

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