Endocan in Ventilator-associated Pneumonia | NCT02916277

Studies
Endocan in Ventilator-associated Pneumonia

NCT02916277

Sponsor

Erzincan University

Status

Unknown status

Last Update Posted

Sep 27, 2016Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Serial Endocan Measurements

Interventions

endocan

Countries

Turkey (Türkiye)

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

Sep 2016

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

Aug 2016

Primary Completion Date

Feb 2017Estimated

Completion Date

Mar 2017Estimated

First Submitted Date

Sep 24, 2016

First Submission Date that Met QC Criteria

Sep 24, 2016

First Posted Date

Sep 27, 2016Estimated

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

Sep 24, 2016

Last Update Posted Date

Sep 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

In this study; in patients undergoing mechanical ventilation, making the day series Endocan measurements during the first 5 day to look at whether there is a relationship between the levels of VAP with Endocan. This relationship, if any, aimed to investigate whether correlated with clinical and laboratory findings [presence of fever, pathological lung X-ray, the number of white blood cells (WBC), procalcitonin (PCT), C-reactive protein (CRP)] .

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

5 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
endocan	Biological	to look series Endocan level for 5 days in intubated patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
relationship between the level of Endocan and development of VAP		9 month

Secondary Outcomes

Measure	Description	Time Frame
correlation with the level of Endocan and clinical and laboratory findings		9 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

over 18 age
Patients whether intubated and connected to a mechanical ventilator

Exclusion Criteria:

patients intubated due to lung problems such as COPD, asthma, pulmonary embolism , etc.
Patients with brain tumors
patients with acute and chronic renal failure
Patients with hypertension
Patients with previously diagnosed infection
Patients with extubated
patients using antibiotics or corticosteroids before bronchoalveolar lavage fluid samples taken

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients whether intubated and connected to a mechanical ventilator

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ILKE KUPELI	Contact	+905555485632		ilkeser2004@gmail.com
FATIH OZCICEK	Contact	+90446222222		fozcicek@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erzincan University	Recruiting	Erzincan			Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10766680	Background	Fagon JY, Chastre J, Wolff M, Gervais C, Parer-Aubas S, Stephan F, Similowski T, Mercat A, Diehl JL, Sollet JP, Tenaillon A. Invasive and noninvasive strategies for management of suspected ventilator-associated pneumonia. A randomized trial. Ann Intern Med. 2000 Apr 18;132(8):621-30. doi: 10.7326/0003-4819-132-8-200004180-00004.
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