Interleukine 6 as a Predictor of Outcome in Mechanically... | NCT05274503

Studies
Interleukine 6 as a Predictor of Outcome in Mechanically Ventilated Patients With Covid 19

NCT05274503

Sponsor

Sohag University

Status

Completed

Last Update Posted

Mar 10, 2022Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Mechanical Ventilation Duration

Interventions

Not provided

Countries

Egypt

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

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Dec 1, 2021Actual

Completion Date

Jan 1, 2022Actual

First Submitted Date

Mar 9, 2022

First Submission Date that Met QC Criteria

Mar 9, 2022

First Posted Date

Mar 10, 2022Actual

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

Mar 9, 2022

Last Update Posted Date

Mar 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Serum IL-6 levels will be determined by enzyme-linked immunosorbent assay according to the manufacturer's instructions and the normal range is <10 pg/mL , Patients' medical records will be carefully reviewed and analyzed. Patient data regarding demographics, comorbidities, signs and symptoms, laboratory results and complications will be collected. The occurrence of complications will be confirmed according to the following criteria: acute respiratory distress syndrome (ARDS) defined according to the Berlin definition

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

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
detection of acute respiratory distress syndrome	hypoxia, incresed plateau pressure	2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

•Age: more than 20 years.
- Gender: both males and females will be included.
- Mechanically Ventilated patients.
- COVID 19 confirmed diagnosis

Exclusion Criteria:

•Immunocompromised patients.
- Oxygen saturation more than 95% without ventilation.
- Malignancy.
- Patients refuse to be enrolled in the study.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients more than 20 years old, covid positive, mechanically ventilated

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sohag University, Faculty of Medicine		Sohag			Egypt