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Investigating the Safety of Edaravone in Aluminum Phosphide Poisoning.

Investigating the effectiveness of injectable edaravone in treating aluminum phosphide poisoning: a pilot clinical trial study.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090627002083N8
Enrollment
40
Registered
2023-11-30
Start date
2023-11-22
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aluminum phosphide poisoning. Toxic effect of phosphorus and its compounds

Interventions

Intervention 1: Intervention group: the treatment protocol recommended by the Ministry of Health plus two vials of edaravone (60 mg in total) in 200 ml of 0.9% sodium chloride infusion solution for tw

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Aluminum phosphide poisoning

Exclusion criteria

Exclusion criteria: Negative silver nitrate test Age less than 18 and more than 60 years Concomitant poisoning with drugs or other compounds Heart failure disease Patients with asthma

Design outcomes

Primary

MeasureTime frame
The percentage of men who have an Ejection Fraction lower than 52%. Timepoint: On the first, third and fifth day of the hospital stay. Method of measurement: Echocardiography.;The proportion of females with an Ejection Fraction less than 54%. Timepoint: On the first, third and fifth day of the hospital stay. Method of measurement: Echocardiography.;The percentage of women with a left ventricular end-diastolic diameter greater than 52 mm. Timepoint: On the first, third and fifth day of the hospital stay. Method of measurement: Echocardiography.;Percentage of men with a left ventricular end-diastolic diameter greater than 59 mm. Timepoint: On the first, third and fifth day of the hospital stay. Method of measurement: Echocardiography.;The percentage of people whose left atrial volume is more than 34 cc/m2 in relation to body surface. Timepoint: On the first, third and fifth day of the hospital stay. Method of measurement: Echocardiography.;The percentage of people who have left ventricular stretch is less than- 20%. Timepoint: On the first, third and fifth day of the hospital stay. Method of measurement: Echocardiography.;The proportion of individuals with an initial diastolic velocity of the left ventricle below 6 cm/s. Timepoint: On the first, third and fifth day of the hospital stay. Method of measurement: Echocardiography.;Initial velocity of the mitral valve during diastole(E). Timepoint: On the first, third and fifth day of the hospital stay. Method of measurement: Echocardiography.;End-diastolic velocity of the mitral valve(A). Timepoint: On the first, third and fifth day of the hospital stay. Method of measurement: Echocardiography.;The percentage of people with a pulmonary artery systolic pressure(SPAP) greater than 35 mmHg. Timepoint: On the first, third and fifth day of the hospital stay. Method of measurement: Echocardiography.;The percentage of people with systolic blood pressure less than 90 mm Hg. Timepoint: Daily. Method of measurement: Sphygmomanomete

Secondary

MeasureTime frame
Inflammation and infection and bruising at the injection site. Timepoint: During hospitalization, one week after discharge. Method of measurement: Observation, examination.;?Anaphylactic shock. Timepoint: During hospitalization. Method of measurement: Observation, examination.;Skin complications. Timepoint: During hospitalization, one week after discharge. Method of measurement: Observation, examination.;Gait disturbance. Timepoint: Upon the initial occasion in which the patient is capable of ambulation. Method of measurement: Observation, examination.;The number of days hospitalized in the intensive care unit. Timepoint: At the time of discharge. Method of measurement: Examining the hospitalization file.;Length of hospital stay in the ward. Timepoint: At the time of discharge. Method of measurement: Examining the hospitalization file.;Mortality in hospitals. Timepoint: At the time of hospitalization. Method of measurement: Examining the hospitalization file.;Cardiac enzymes. Timepoint: First day, third day, fifth day of hospitalisation. Method of measurement: The laboratory kit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Reza Mousavi

Mashhad University of Medical Sciences

Mousavir@mums.ac.ir+98 51 3859 8973

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026