Frequencies of Histo-pathological Findings in Patients Wi... | NCT01153230

Studies
Frequencies of Histo-pathological Findings in Patients With Paraquat Toxicity

NCT01153230

Sponsor

Isfahan University of Medical Sciences

Status

Completed

Last Update Posted

Jun 30, 2010Estimated

Enrollment

42Actual

Phase

Not provided

Conditions

Paraquat Toxicity

Interventions

Not provided

Countries

Iran

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

Nov 2008

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

Dec 2002

Primary Completion Date

Nov 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Jun 29, 2010

First Submission Date that Met QC Criteria

Jun 29, 2010

First Posted Date

Jun 30, 2010Estimated

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

Jun 29, 2010

Last Update Posted Date

Jun 30, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to determine frequencies of histo-pathological findings in dead poisoned patients and evaluate their relationships with age, gender, dosage of poisoning, time of admission and time of death.

Detailed Description

Acute poisoning of paraquat which is taken either to commit suicide or by mistake has become a social problem in world. The present study was conducted to determine frequencies of histo-pathological findings in dead poisoned patients and evaluate their relationships with age, gender, dosage of poisoning, time of admission and time of death.

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

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
poisoned patient		after patients died the pathological findings evaluated with autopsy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
histo-pathological findings	for evaluate of this outcome we gather autopsy data	1 day after patient died

Secondary Outcomes

Measure	Description	Time Frame
age	we gathered demogeraphic data such as age	5 min after admission time
gender	we gathered demographic data such as gender	5 min after admission time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

every patients who dithionate test were positive

Exclusion Criteria:

nothing

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

forty two poisoned patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
hamidreza shemshaki, MD	MD,research comittee	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Noor university hospital		Isfahan			Iran