NCT03879356

Brief Summary

Aluminum phosphide poisoning (ALP) is a global public health problem, and self-poisoning accounts for one-third of the world's suicide rate. In fact, in some parts of developing countries, pesticide poisoning causes more deaths than infection. ALP is very common in our government and the prognosis of the cases is usually so bad. Toxicity by ALP is caused by the liberation of phosphine gas, which causes cell hypoxia due to inhibition of oxidative phosphorylation leading to circulatory failure.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2016

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, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

6 months

First QC Date

March 13, 2019

Last Update Submit

March 15, 2019

Conditions

Detection of Different Prognostic Factors and Their Relation With the OutcomeUsing New Protocol to Prove the Role of N-acetyl Cysteine and Adequate Supportive Measures in Aluminum Phosphide Poisoning

Keywords

Aluminum phosphideN-acetylcysteinAssiutprognostic factors

Outcome Measures

Primary Outcomes (2)

  • mortality rate comparison

    comparison of mortality rate using the New protocol and previous mortality rate from archive records

    3 days

  • hospital stay

    number of days the patient stayed at hospital

    3 days

Study Arms (1)

Aluminum phosphide patients

OTHER

effect of N-acetyl cysteine and supportive measures in outcome of aluminum phosphide poisoning cases

Drug: N-acetyl cysteine

Interventions

N-acetyl cysteineDRUG

effect of N-acetyl cysteine in Aluminum phosphide poisoning patients

Aluminum phosphide patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All the cases with the primary diagnosis of Aluminum phosphide toxicity will be included in the study.
  • Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

You may not qualify if:

  • Patients with a history of any chronic disease (renal and hepatic).
  • Patients refuse to participate in the study.
  • Aged less than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 18, 2019

Study Start

January 1, 2016

Primary Completion

June 30, 2016

Study Completion

March 14, 2017

Last Updated

March 18, 2019

Record last verified: 2019-03