NCT05215444

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

29 days

First QC Date

January 17, 2022

Last Update Submit

January 25, 2023

Conditions

Aluminum Phosphide Poisoning

Outcome Measures

Primary Outcomes (1)

  • prognosis

    predict the mortality of intoxicated AlP cases

    the first 24 post poisoning

Study Arms (2)

survivors

Diagnostic Test: some prognostic factors

non survivors

Diagnostic Test: some prognostic factors

Interventions

some prognostic factorsDIAGNOSTIC_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

non survivorssurvivors

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

the mode of toxicity is suicidal by ingestion of AlP tablet

You may qualify if:

  • 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

You may not qualify if:

  • \- 1. Cases with an unclear history. 2. History of co-morbidities or systemic diseases because of the possibility of misleading laboratory results.
  • \. History of co-ingestion of drugs or another poison.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Zagazig University

Zagazig, Sharqia Province, 44511, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
demonstrator

Study Record Dates

First Submitted

January 17, 2022

First Posted

January 31, 2022

Study Start

January 1, 2021

Primary Completion

January 30, 2021

Study Completion

June 30, 2021

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)