Back to resultsPotential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning
Primary Purpose
Toxicity, Drug
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Paraffin oil gastric lavage
Gastric lavage with saline and sodium bicarbonate 8.4%
Sponsored by
About this trial
This is an interventional treatment trial for Toxicity, Drug
Eligibility Criteria
Inclusion Criteria:
- • Patients with symptomatic acute aluminum phosphide poisoning
Exclusion Criteria:
• 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
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Paraffin oil gastric lavafe
Saline gastric lavage
Arm Description
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
Outcomes
Primary Outcome Measures
Number of deaths
The number of deaths
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04499885
Brief Title
Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning
Official Title
Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 1, 2030 (Anticipated)
Study Completion Date
December 10, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toxicity, Drug
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Paraffin oil gastric lavafe
Arm Type
Active Comparator
Arm Description
Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution
Arm Title
Saline gastric lavage
Arm Type
Active Comparator
Arm Description
Gastric lavage with saline and sodium bicarbonate
Intervention Type
Device
Intervention Name(s)
Paraffin oil gastric lavage
Other Intervention Name(s)
Paraffin oil
Intervention Description
Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution
Intervention Type
Device
Intervention Name(s)
Gastric lavage with saline and sodium bicarbonate 8.4%
Other Intervention Name(s)
Saline gastric lavage
Intervention Description
Gastric lavage with saline and sodium bicarbonate 8.4%
Primary Outcome Measure Information:
Title
Number of deaths
Description
The number of deaths
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Patients with symptomatic acute aluminum phosphide poisoning
Exclusion Criteria:
• 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, ass. prof.
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadia Ezzat Helal, Ass. Prof.
Organizational Affiliation
Forensic medicine Department- Tanta University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ayman Nagy, ass. Prof.
Organizational Affiliation
Forensic medicine Department- Tanta University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ghada N. El-Sarnagawy, ass. Prof.
Organizational Affiliation
Forensic medicine Department- Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sherief abd-elsalam, ass. prof
Phone
00201147773440
Email
sheroefabdelsalam@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning
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