Impact of Respiratory Virus in Critically Ill Patients Wi... | NCT04411368

Studies
Impact of Respiratory Virus in Critically Ill Patients With Acute Respiratory Failure

NCT04411368

Sponsor

Seoul St. Mary's Hospital

Status

Unknown status

Last Update Posted

Jun 2, 2020Actual

Enrollment

540Estimated

Phase

Not provided

Conditions

Acute Respiratory Failure
Acute Respiratory Distress Syndrome

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Estimated

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

May 27, 2020

First Submission Date that Met QC Criteria

May 30, 2020

First Posted Date

Jun 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2020

Last Update Posted Date

Jun 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an observational study to evaluate the clinical impact of respiratory virus in the patients with acute respiratory failure

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

540Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of respiratory viral infections	Rate of respiratory viral infections in patients with acute respiratory failure	within 24 hours after intensive care unit (ICU) admission

Secondary Outcomes

Measure	Description	Time Frame
ICU mortality rate	Association between respiratory viral infections and death in ICU and risk factors of death in patients with ARF	Through study completion, an average of 1 year
Hospital mortality rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female aged ≥ 19 years
Written informed consent by the patient or legally authorized representative
Critical illness consistent with acute respiratory failure, to be enrolled within 24 hours of presentation

Exclusion Criteria:

No informed consent
A patient who is judged to be unable to make a voluntary decision by understanding information about this research due to cognitive vulnerability

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects with presentation to ICU with critical illness compatible with acute respiratory failrue.

* Definition of acute respiratory failure: Patients who met one of following criteria

SaO2 < 90% on room air
SaO2 < 92% on > 6L/min of oxygen
Respiratory rates > 30/min, or sign of respiratory distress

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jongmin Lee, Ph.D	Contact	+821063007128		dibs03@gmail.com

Overall Officials

Name	Affiliation	Role
Jongmin Lee	Seoul St. Mary's Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul St. Mary's Hospital	Recruiting	Seoul		06591	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided