Toxicity, DrugNCT04499885
Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning
A study testing Paraffin oil gastric lavage and Gastric lavage with saline and sodium bicarbonate 8.4% in people with Toxicity, Drug, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Toxicity, Drug
- What is being tested?
- Paraffin oil gastric lavage and Gastric lavage with saline and sodium bicarbonate 8.4%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 10 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • Patients with symptomatic acute aluminum phosphide poisoning
Who cannot join
- • Pregnant and lactating women
- Asymptomatic patients with history of acute aluminum phosphide exposure.
- Patients with ingestion or exposure to other substances in addition to aluminum phosphide.
- Patients with other major medical conditions (e.g. cardiovascular disease, renal or hepatic failure).
- Patients with previous medical intervention (had gastric lavage in any medical center before admission).
- Patients with disturbed consciousness level
- Patients with post cardiac arrest cases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Tanta
sherief abd-elsalam, ass. prof, 00201147773440, sheroefabdelsalam@yahoo.com
About this study
Official title: Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial
Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning.
Read the detailed description
The study aims to investigate the Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial
- Conditions
- Toxicity, Drug
- Being tested
- Paraffin oil gastric lavage, Gastric lavage with saline and sodium bicarbonate 8.4%
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paraffin oil gastric lavageDevice
Also called Paraffin oil
Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution
Gastric lavage with saline and sodium bicarbonate 8.4%Device
Also called Saline gastric lavage
Gastric lavage with saline and sodium bicarbonate 8.4%
| Study group | Role | What they receive |
|---|---|---|
| Paraffin oil gastric lavafe | Active comparator | Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution Receives: Device: Paraffin oil gastric lavage |
| Saline gastric lavage | Active comparator | Gastric lavage with saline and sodium bicarbonate Receives: Device: Gastric lavage with saline and sodium bicarbonate 8.4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of deaths
The number of deaths
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Jun 2020
- Primary completion1 Dec 2030 (estimated)
- Study completion10 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toxicity, DrugStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Nadia Ezzat Helal, Ass. Prof., Principal investigator, Forensic medicine Department- Tanta UniversityAyman Nagy, ass. Prof., Principal investigator, Forensic medicine Department- Tanta UniversityGhada N. El-Sarnagawy, ass. Prof., Principal investigator, Forensic medicine Department- Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499885
- Sponsor's protocol ID
- ghada protocol
- Status last verified
- Aug 2020
- First submitted
- 1 Aug 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04499885
- Acronym / sponsor ID
- ghada protocol
- Conditions
- Toxicity, Drug
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 10 Dec 2030 (estimated)
- First posted
- 5 Aug 2020 (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.
Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning.
Detailed description
The study aims to investigate the Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paraffin oil gastric lavafe | Active comparator | Device: Paraffin oil gastric lavageGastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution |
| Saline gastric lavage | Active comparator | Device: Gastric lavage with saline and sodium bicarbonate 8.4%Gastric lavage with saline and sodium bicarbonate |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- • Patients with symptomatic acute aluminum phosphide poisoning
Key exclusion criteria (7 listed)
- • Pregnant and lactating women
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 |
|---|---|---|
| Paraffin oil gastric lavageAlso: Paraffin oilGastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution | Device | Paraffin oil gastric lavafe |
| Gastric lavage with saline and sodium bicarbonate 8.4%Also: Saline gastric lavageGastric lavage with saline and sodium bicarbonate 8.4% | Device | Saline gastric lavage |
Primary outcome
Number of deaths
Time frame: 6 months
The number of deaths
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Nadia Ezzat Helal, Ass. Prof. principal investigator
Forensic medicine Department- Tanta University
Ayman Nagy, ass. Prof. principal investigator
Forensic medicine Department- Tanta University
Ghada N. El-Sarnagawy, ass. Prof. principal investigator
Forensic medicine Department- Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paraffin oil gastric lavage and Gastric lavage with saline and sodium bicarbonate 8.4% in people with Toxicity, Drug, run by Sherief Abd-Elsalam 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 1 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 5 Aug 2020. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, ass. prof. (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of deaths (time frame: 6 months). 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 5 Aug 2020.