NCT04702906

Brief Summary

The aim of the present study is to evaluate the potential adjuvant therapeutic effect of trimetazidine in treatment of acute AlP poisoning-induced cardiotoxicity.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

December 15, 2020

Last Update Submit

January 8, 2021

Conditions

Aluminum Phosphide Poisoning

Outcome Measures

Primary Outcomes (1)

  • Mortality

    mortality rate

    7 days

Secondary Outcomes (1)

  • Duration of ventilation

    7 days

Study Arms (2)

control group

ACTIVE COMPARATOR

All patients will continue to receive the standard treatment, which is determined by the attending physician who maintains clinical responsibility for all patients. Conventional standard treatment included using inotropes, fluids and electrolytes resuscitation, intubation, mechanical ventilation, and antiarrhythmic agents if indicated.

Other: standard treatment

trimetazidine group

ACTIVE COMPARATOR

The trimetazidine group will receive conventional standard treatment plus Trimetazidine dihydrochloride "metacardia" ® (20 mg three times daily produced by Pharco-Egypt) will be administered twice every 24 hours until at least treatment is no longer needed.

Other: standard treatmentDrug: trimetazidine hydrochloride "metacardia" ® 20 mg tablet

Interventions

standard treatmentOTHER

Standard treatment if indicated.

control grouptrimetazidine group
trimetazidine hydrochloride "metacardia" ® 20 mg tabletDRUG

trimetazidine hydrochloride "metacardia" ® (20 mg three times daily produced by Global NAPI Pharmaceuticals-Egypt)

trimetazidine group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients included in this study will be diagnosed as acute aluminum phosphide poisoning by history and clinical pictures.
  • Age is18 years or older.

You may not qualify if:

  • Pregnant and lactating women.
  • Patients with ingestion or exposure to other substances in addition to aluminum phosphide.
  • Patients with other major medical conditions (e.g. cardiovascular disease, diabetes mellitus, renal or hepatic failure).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Tablets

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Central Study Contacts

nadia helal, MD

CONTACT

00201099752866dr_nadia_helal86@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

December 15, 2020

First Posted

January 11, 2021

Study Start

February 1, 2021

Primary Completion

June 1, 2021

Study Completion

July 1, 2021

Last Updated

January 11, 2021

Record last verified: 2021-01