Aluminum Phosphide PoisoningEarly Phase 1NCT04724655
Paraffin Oil or Coconut Oil in Acute Aluminum Phosphide Poisoning
A Early Phase 1 study testing gastric lavage with paraffin oil and bicarbonate, gastric lavage with coconut oil and bicarbonate and standard treatment in people with Aluminum Phosphide Poisoning, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of the present study is to evaluate safety and efficacy of gastric lavage with paraffin oil or gastric lavage with coconut oil in management of acute Aluminum phosphide poisoning. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Aluminum Phosphide Poisoning
- What is being tested?
- gastric lavage with paraffin oil and bicarbonate, gastric lavage with coconut oil and bicarbonate and standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 15 Sep 2021
- Phase
- Early Phase 1
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • Patients with symptomatic acute aluminum phosphide poisoning
- Age is more than 12 years of both gender
- Patients presenting within 6 hours post-ingestion of aluminum phosphide
Who cannot join
- • Patients less than 12 years of age
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gastric Lavage With Paraffin Oil or Coconut Oil in Management of Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial.
The aim of the present study is to evaluate safety and efficacy of gastric lavage with paraffin oil or gastric lavage with coconut oil in management of acute Aluminum phosphide poisoning.
Read the detailed description
60 patients will be randomly assigned as control groups, paraffin group, and coconut group in a 1:1:1 ratio (30 patients in each group).
Inclusion criteria:
- Patients with symptomatic acute aluminum phosphide poisoning
- Age is more than 12 years of both gender
- Patients presenting within 6 hours post-ingestion of aluminum phosphide (Papade and Vanjari, 2019).
The diagnosis is made on the basis of:
- The suggestive clinical manifestations due to and following shortly after a single exposure to aluminum phosphide.
- Reliable identification of the compound based on the container brought by patient attendants.
- Biochemical detection of phosphine gas in gastric aspirate (silver nitrate test).
- Group (I): Gastric lavage with saline and sodium bicarbonate 8.4% then aspiration will be done after 3-5 min through nasogastric tube (Control group)
- Group (II): Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution 8.4%, then aspiration will be done after 3-5 min through nasogastric tube (Paraffin group).
- Group (III): Gastric lavage will be initiated with 50 ml coconut oil and 50 ml sodium bicarbonate 8.4 % then aspiration will be done after 3-5 min through nasogastric tube (Coconut group).
- All patients will continue to receive the standard supportive treatment according to Tanta University Poison Control Center protocol, 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.
- Conditions
- Aluminum Phosphide Poisoning
- Being tested
- gastric lavage with paraffin oil and bicarbonate, gastric lavage with coconut oil and bicarbonate, standard treatment, gastric lavage with saline and bicarbonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric lavage with paraffin oil and bicarbonateOther
Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution 8.4%, then aspiration will be done after 3-5 min through nasogastric tube
gastric lavage with coconut oil and bicarbonateOther
Gastric lavage will be initiated with 50 ml coconut oil and 50 ml sodium bicarbonate 8.4 % then aspiration will be done after 3-5 min through nasogastric tube
inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate
gastric lavage with saline and bicarbonateOther
Gastric lavage with saline and sodium bicarbonate 8.4% then aspiration will be done after 3-5 min through nasogastric tube
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | gastric lavage with saline and bicarbonate and standard treatment :inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate Receives: Drug: standard treatment; Other: gastric lavage with saline and bicarbonate |
| paraffin group | Active comparator | gastric lavage with paraffin oil and bicarbonate and standard treatment :inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate Receives: Other: gastric lavage with paraffin oil and bicarbonate; Drug: standard treatment |
| coconut group | Active comparator | gastric lavage with coconut oil and bicarbonate and standard treatment :inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate Receives: Other: gastric lavage with coconut oil and bicarbonate; Drug: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Jan 2021
- Primary completion30 Jun 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aluminum Phosphide PoisoningStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, samah maher, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724655
- Sponsor's protocol ID
- oils and aluminum phosphide
- Status last verified
- Jun 2022
- First submitted
- 19 Jan 2021
- Last updated
- 8 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Lavage With Paraffin Oil or Coconut Oil in Management of Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04724655
- Acronym / sponsor ID
- oils and aluminum phosphide
- Conditions
- Aluminum Phosphide Poisoning
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 26 Jan 2021 (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.
The aim of the present study is to evaluate safety and efficacy of gastric lavage with paraffin oil or gastric lavage with coconut oil in management of acute Aluminum phosphide poisoning.
Detailed description
60 patients will be randomly assigned as control groups, paraffin group, and coconut group in a 1:1:1 ratio (30 patients in each group).
Inclusion criteria:
- Patients with symptomatic acute aluminum phosphide poisoning
- Age is more than 12 years of both gender
- Patients presenting within 6 hours post-ingestion of aluminum phosphide (Papade and Vanjari, 2019).
The diagnosis is made on the basis of:
- The suggestive clinical manifestations due to and following shortly after a single exposure to aluminum phosphide.
- Reliable identification of the compound based on the container brought by patient attendants.
- Biochemical detection of phosphine gas in gastric aspirate (silver nitrate test).
- Group (I): Gastric lavage with saline and sodium bicarbonate 8.4% then aspiration will be done after 3-5 min through nasogastric tube (Control group)
- Group (II): Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution 8.4%, then aspiration will be done after 3-5 min through nasogastric tube (Paraffin group).
- Group (III): Gastric lavage will be initiated with 50 ml coconut oil and 50 ml sodium bicarbonate 8.4 % then aspiration will be done after 3-5 min through nasogastric tube (Coconut group).
- All patients will continue to receive the standard supportive treatment according to Tanta University Poison Control Center protocol, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Drug: standard treatment, Other: gastric lavage with saline and bicarbonategastric lavage with saline and bicarbonate and standard treatment :inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate |
| paraffin group | Active comparator | Other: gastric lavage with paraffin oil and bicarbonate, Drug: standard treatmentgastric lavage with paraffin oil and bicarbonate and standard treatment :inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate |
| coconut group | Active comparator | Other: gastric lavage with coconut oil and bicarbonate, Drug: standard treatmentgastric lavage with coconut oil and bicarbonate and standard treatment :inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- • Patients with symptomatic acute aluminum phosphide poisoning
Key exclusion criteria (4 listed)
- • Patients less than 12 years of age
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 |
|---|---|---|
| gastric lavage with paraffin oil and bicarbonateGastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution 8.4%, then aspiration will be done after 3-5 min through nasogastric tube | Other | paraffin group |
| gastric lavage with coconut oil and bicarbonateGastric lavage will be initiated with 50 ml coconut oil and 50 ml sodium bicarbonate 8.4 % then aspiration will be done after 3-5 min through nasogastric tube | Other | coconut group |
| standard treatmentinotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate | Drug | coconut group, control group, paraffin group |
| gastric lavage with saline and bicarbonateGastric lavage with saline and sodium bicarbonate 8.4% then aspiration will be done after 3-5 min through nasogastric tube | Other | control group |
Primary outcome
death
Time frame: 72 hours
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 8 Jun 2022.
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Toxicity, Drug
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing gastric lavage with paraffin oil and bicarbonate, gastric lavage with coconut oil and bicarbonate and standard treatment in people with Aluminum Phosphide Poisoning, run by Tanta University at 1 site in Egypt.
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 3 inclusion and 4 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 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
death (time frame: 72 hours). 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 8 Jun 2022.