Evaluation of Some Prognostic Factors in Acute Aluminum P... | NCT05215444

Studies
Evaluation of Some Prognostic Factors in Acute Aluminum Phosphide Intoxicated Cases

NCT05215444

Sponsor

Zagazig University

Status

Completed

Last Update Posted

Jan 26, 2023Actual

Enrollment

42Actual

Phase

Not provided

Conditions

Aluminum Phosphide Poisoning

Interventions

some prognostic factors

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

Jan 2023

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

Jan 1, 2021Actual

Primary Completion Date

Jan 30, 2021Actual

Completion Date

Jun 30, 2021Actual

First Submitted Date

Jan 17, 2022

First Submission Date that Met QC Criteria

Jan 17, 2022

First Posted Date

Jan 31, 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

Jan 25, 2023

Last Update Posted Date

Jan 26, 2023Actual

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

study of some laboratory and clinical findings which may show the severity of aluminium phosphide toxicity and the need of the cases to be admitted to ICU

Detailed Description

aluminium phosphide poisoning is a major cause of death in intoxicated and suicidal cases since there is no antidote and there is no specific investigation for it so there is a need for further study to identify the cause of death and the most specific investigation in the case of AlP toxicity

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

Retention

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
survivors			Diagnostic Test: some prognostic factors
non survivors			Diagnostic Test: some prognostic factors

Interventions

Name	Type	Description	Arm Group Labels	Other Names
some prognostic factors	Diagnostic Test	cortisol level, renin, troponin I, MDA ,catalase, super oxide dismutase, liver functions, kidney functions, arterial blood gases, sodium level, potassium level. white blood cells count

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prognosis	predict the mortality of intoxicated AlP cases	the first 24 post poisoning

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

History of exposure or intake of Aluminum phosphide.
Clinical picture of Acute Aluminum phosphide poisoning including severe vomiting, hypotension, abdominal pain, cardio-pulmonary distress.
Cases of the age of 15 to 45 years old

Exclusion Criteria:

- 1. Cases with an unclear history. 2. History of co-morbidities or systemic diseases because of the possibility of misleading laboratory results.

3. History of co-ingestion of drugs or another poison.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

the mode of toxicity is suicidal by ingestion of AlP tablet

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine Zagazig University		Zagazig	Sharqia Province	44511	Egypt

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

Description

10 cm of blood will be collected from included patients on admission, 2cm in tube contain EDTA to perform CBC test and 8 cm will be transferred to a dry clean centrifuge tube and will be left upright to clot then it will be centrifuged for 10 minutes at 5000rpm, the serum will be separated and preserved at -80°C to be used later for further biochemical analyses