Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-04 @ 1:37 PM
Study NCT ID:
NCT02983851
Status:
UNKNOWN
Last Update Posted:
2016-12-06
First Post:
2016-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure
Sponsor:
Peking Union Medical College Hospital
Organization:
Study Overview
Official Title:
Initial Ventilation Strategy for Adult Immunocompromised Patients With Acute Respiratory Failure
Status:
UNKNOWN
Status Verified Date:
2016-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
VENIM is a multicenter, open-label, parallel-group randomized controlled trial of studying the initial ventilation strategy for adult immunocompromised patients with acute respiratory failure.
Detailed Description:
The VENIM is a multicenter randomized controlled trial (RCT) comparing the effects of NIV compared with IMV in adult immunocompromised patients with moderate to severe acute respiratory failure (ARF). Patients who meet the indications for both ventilatory supports will be included. The intervention will consist of randomly allocation, treatment with NIV or IMV, concomitant medication. Primary outcome is 30-day hospital mortality. Secondary outcomes include in-hospital mortality, length of stay in hospital, improvement of oxygenation, nosocomial infections, seven-day organ failure, adverse events of intervention, et al. Subgroups with different disease severity, causes of immunodeficiency and types of ARF will also be analyzed.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: