Effects of Resistin on Neutrophil Function | NCT03626870

Studies
Effects of Resistin on Neutrophil Function

NCT03626870

Sponsor

Milton S. Hershey Medical Center

Status

Withdrawn

Last Update Posted

Dec 10, 2024Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Inflammation

Interventions

Not provided

Countries

United States

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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

does not meet criteria for clinical trial

Expanded Access Info

Start Date

Sep 1, 2018Estimated

Primary Completion Date

Sep 1, 2019Estimated

Completion Date

Sep 1, 2019Estimated

First Submitted Date

Aug 3, 2018

First Submission Date that Met QC Criteria

Aug 9, 2018

First Posted Date

Aug 13, 2018Actual

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

Dec 5, 2024

Last Update Posted Date

Dec 10, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anthony Bonavia, Professor, Department of Anesthesiology, Penn State Health Milton S Hershey Medical CenterPrincipal Investigator

Lead Sponsor

Milton S. Hershey Medical CenterOTHER

Collaborators

Not provided

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

FDAAA801 Violation

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

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intracellular bacterial killing, assessed by number of colonies of bacterial growth following neutrophil exposure to bacteria and resistin		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

age ≥ 18
gender: male or female

Exclusion Criteria

Adults who are unable to provide informed consent themselves
History of chronic kidney disease as defined by estimated glomerular filtration rate (GFR) <60 ml/min prior to cardiogenic shock
Patients with hematologic malignancies
Pregnant women
Patient/surrogate is not fluent in English
Long-term immunosuppressive therapy
Prisoner
Patients on pre-existing continuous reno-renal therapy (CRRT) or intermittent hemodialysis (IHD

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

all healthy volunteer adults

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anthony Bonavia, MD	Penn State Milton S Hershey Med Ctr	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Penn State Milton S Hershey Medical Center		Hershey	Pennsylvania	17033	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007249	Inflammation

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided