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

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Completed
• CT.gov ID: NCT01915719
• Collaborator: (none)
• Enrollment: 374
• Location: 1
• Arms: 2
• Duration (Months): 30
• Patients Per Site Per Month: 12.5

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Aug 1, 2013
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Day 28 Mortality [Day 28]

Secondary Outcome Measures

1. Needs of mechanical ventilation [Day 28]

2. SOFA Score [Hour 72]

3. Nosocomial infection [day 28]

4. Length of stay in ICU [Day 28]

5. performance status (OMS scale ranging from 0-perfect status- to 4-moribund) [6 Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	APHP, Hôpital Saint Louis	Paris		France	75010

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Virginie lemiale, MD, APHP

Study Documents (Full-Text)

None provided.

More Information

Publications

• Lemiale V, Resche-Rigon M, Azoulay E; Study Group for Respiratory Intensive Care in Malignancies Groupe de Recherche en Réanimation Respiratoire du patient d'Onco-Hématologie. 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.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT01915719
• Other Study ID Numbers: IVNICTUS
• First Posted: Aug 5, 2013
• Last Update Posted: Apr 18, 2016
• Last Verified: Nov 1, 2015

• Additional relevant MeSH terms: Respiratory Insufficiency; Respiratory Distress Syndrome

Study Results

No Results Posted as of Apr 18, 2016