Urinary Cytokine Levels as a Prognostic Marker for Kidney... | NCT00868270

Studies
Urinary Cytokine Levels as a Prognostic Marker for Kidney Scarring After Pyelonephritis

NCT00868270

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Mar 24, 2009Estimated

Enrollment

35Estimated

Phase

Not provided

Conditions

Kidney Scarring Post-Febrile UTI

Interventions

Not provided

Countries

Israel

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 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 22, 2009

First Submission Date that Met QC Criteria

Mar 22, 2009

First Posted Date

Mar 24, 2009Estimated

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 22, 2009

Last Update Posted Date

Mar 24, 2009Estimated

Description Module

Brief Summary

The prevalence of kidney scarring after UTI is approximately 5-57%. UTIs are caused mainly by bacteria that cause local and systemic immunological reaction that are accompanied by cytokines. These cytokines are a main factor in the inflammatory process. They are produced by leukocytes, macrophages, fibroblasts, endothelial cells and epithelial cells in the kidney tissue. Interleukin 6 and 8 (IL-6 IL-8) were found in high levels in the urine of children and adults who suffer from UTIs. Other studies on animals have found a relationship between inflammatory reaction and scarring in the kidney. We hypothesize that we will find a similar relationship between the level of IL-6, IL-8 in the urine during acute pyelonephritis in children and the probability of kidney scarring.

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

Not provided

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

35Estimated

Label	Type	Description	Intervention Names
Children with UTIs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
High prevalence of kidney scarring in children with high levels of urine interleukins		six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged 0-7
First episode febrile UTI

Exclusion Criteria:

Recurrent UTI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

7 Years

Standard Ages

Child

Study Population

Hospitalized children with UTIs

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hassan Jassar, MD	Contact	972-4-630-4332		hasjassar@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38100	Israel