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Paraffin Oil or Coconut Oil in Acute Aluminum Phosphide Poisoning

Primary Purpose

Aluminum Phosphide Poisoning

Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
gastric lavage with paraffin oil and bicarbonate
gastric lavage with coconut oil and bicarbonate
standard treatment
gastric lavage with saline and bicarbonate
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aluminum Phosphide Poisoning

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria:

  • • 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).

Sites / Locations

  • Tantau

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Active Comparator

Arm Label

control group

paraffin group

coconut group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

death

Secondary Outcome Measures

Full Information

First Posted
January 19, 2021
Last Updated
June 6, 2022
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04724655
Brief Title
Paraffin Oil or Coconut Oil in Acute Aluminum Phosphide Poisoning
Official Title
Gastric Lavage With Paraffin Oil or Coconut Oil in Management of Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aluminum Phosphide Poisoning

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Other
Arm Description
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
Arm Title
paraffin group
Arm Type
Active Comparator
Arm Description
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
Arm Title
coconut group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
gastric lavage with paraffin oil and bicarbonate
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
gastric lavage with coconut oil and bicarbonate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
standard treatment
Intervention Description
inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate
Intervention Type
Other
Intervention Name(s)
gastric lavage with saline and bicarbonate
Intervention Description
Gastric lavage with saline and sodium bicarbonate 8.4% then aspiration will be done after 3-5 min through nasogastric tube
Primary Outcome Measure Information:
Title
death
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Exclusion Criteria: • 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).
Facility Information:
Facility Name
Tantau
City
Tanta
Country
Egypt

12. IPD Sharing Statement

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Paraffin Oil or Coconut Oil in Acute Aluminum Phosphide Poisoning

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