Detection of Different Prognostic Factors and Their Relation With the OutcomePhase 4NCT03879356
Supportive Measures in Treatment of Aluminum Phosphide Poisoning
A Phase 4 study testing N-acetyl cysteine in people with Detection of Different Prognostic Factors and Their Relation With the Outcome and Using New Protocol to Prove the Role of N-acetyl Cysteine and Adequate Supportive Measures in Aluminum Phosphide Poisoning, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Detection of Different Prognostic Factors and Their Relation With the Outcome, Using New Protocol to Prove the Role of N-acetyl Cysteine and Adequate Supportive Measures in Aluminum Phosphide Poisoning
- What is being tested?
- N-acetyl cysteine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 14 Mar 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients with a history of any chronic disease (renal and hepatic).
- Patients refuse to participate in the study.
- Aged less than 18 years
About this study
Official title: Supportive Measures in Treatment of Aluminum Phosphide Poisoning as a Trial to Reduce Mortality at Assiut University Hospital
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.
Read the detailed description
Aluminum phosphide poisoning is a major problem, accounting for many Emergency Unit visits and hospitalization, the incidence of aluminum phosphide poisoning increasing in the last few years.
ALP is used as pesticides for many years to protect grains in stores and during its transportation. The availability of these tablets and their low cost make it an easy and common method of suicide in our country with the increasing incidence of social and financial problems that face the youth.
In management, the main objective is to provide effective oxygenation, ventilation, and circulation until phosphine is excreted. All patients of severe ALP poisoning require continuous invasive hemodynamic monitoring and early resuscitation with fluid and vasoactive agents. N- acetylcysteine as an antioxidant and cytoprotective agent reduces myocardial oxidative injury and increase survival time. Magnesium sulfate helps in scavenging free radicals through glutathione (GSH) recovery hence is effective as a parenteral antioxidant in this poisoning as well as has been tried for its general membrane stabilizing effect in cardiac cells .
Death after 24 hours occurs usually owing to shock, cardiac arrhythmia, metabolic acidosis, and acute respiratory distress syndrome.
- Conditions
- Detection of Different Prognostic Factors and Their Relation With the Outcome, Using New Protocol to Prove the Role of N-acetyl Cysteine and Adequate Supportive Measures in Aluminum Phosphide Poisoning
- Being tested
- N-acetyl cysteine
- Keywords
- Aluminum phosphide, N-acetylcystein, Assiut, prognostic factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl cysteineDrug
effect of N-acetyl cysteine in Aluminum phosphide poisoning patients
| Study group | Role | What they receive |
|---|---|---|
| Aluminum phosphide patients | Other | effect of N-acetyl cysteine and supportive measures in outcome of aluminum phosphide poisoning cases Receives: Drug: N-acetyl cysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate comparison
comparison of mortality rate using the New protocol and previous mortality rate from archive records
Measured: 3 days
hospital stay
number of days the patient stayed at hospital
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Jan 2016
- Primary completion30 Jun 2016
- Study completion14 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Detection of Different Prognostic Factors and Their Relation With the OutcomeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MKMAbdelrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879356
- Sponsor's protocol ID
- AluminumPhosphideAssiut
- Status last verified
- Mar 2019
- First submitted
- 13 Mar 2019
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supportive Measures in Treatment of Aluminum Phosphide Poisoning as a Trial to Reduce Mortality at Assiut University Hospital
- ClinicalTrials.gov ID
- NCT03879356
- Acronym / sponsor ID
- AluminumPhosphideAssiut
- Conditions
- Detection of Different Prognostic Factors and Their Relation With the Outcome, Using New Protocol to Prove the Role of N-acetyl Cysteine and Adequate Supportive Measures in Aluminum Phosphide Poisoning
- Keywords
- Aluminum phosphide, N-acetylcystein, Assiut, prognostic factors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 14 Mar 2017 (actual)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aluminum phosphide poisoning is a major problem, accounting for many Emergency Unit visits and hospitalization, the incidence of aluminum phosphide poisoning increasing in the last few years.
ALP is used as pesticides for many years to protect grains in stores and during its transportation. The availability of these tablets and their low cost make it an easy and common method of suicide in our country with the increasing incidence of social and financial problems that face the youth.
In management, the main objective is to provide effective oxygenation, ventilation, and circulation until phosphine is excreted. All patients of severe ALP poisoning require continuous invasive hemodynamic monitoring and early resuscitation with fluid and vasoactive agents. N- acetylcysteine as an antioxidant and cytoprotective agent reduces myocardial oxidative injury and increase survival time. Magnesium sulfate helps in scavenging free radicals through glutathione (GSH) recovery hence is effective as a parenteral antioxidant in this poisoning as well as has been tried for its general membrane stabilizing effect in cardiac cells .
Death after 24 hours occurs usually owing to shock, cardiac arrhythmia, metabolic acidosis, and acute respiratory distress syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aluminum phosphide patients | Other | Drug: N-acetyl cysteineeffect of N-acetyl cysteine and supportive measures in outcome of aluminum phosphide poisoning cases |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with a history of any chronic disease (renal and hepatic).
- Patients refuse to participate in the study.
- Aged less than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetyl cysteineeffect of N-acetyl cysteine in Aluminum phosphide poisoning patients | Drug | Aluminum phosphide patients |
Primary outcome
mortality rate comparison
Time frame: 3 days
comparison of mortality rate using the New protocol and previous mortality rate from archive records
hospital stay
Time frame: 3 days
number of days the patient stayed at hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing N-acetyl cysteine in people with Detection of Different Prognostic Factors and Their Relation With the Outcome and Using New Protocol to Prove the Role of N-acetyl Cysteine and Adequate Supportive Measures in Aluminum Phosphide Poisoning, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality rate comparison (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2019.