Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning

August 1, 2020 updated by: Sherief Abd-Elsalam

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Recruiting
        • Sherief Abd-Elsalam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Paraffin oil gastric lavafe
Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution
Device: Paraffin oil gastric lavage
Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution
Other Names:
  • Paraffin oil
ACTIVE_COMPARATOR: Saline gastric lavage
Gastric lavage with saline and sodium bicarbonate
Device: Gastric lavage with saline and sodium bicarbonate 8.4%
Gastric lavage with saline and sodium bicarbonate 8.4%
Other Names:
  • Saline gastric lavage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of deaths
Time Frame: 6 months
The number of deaths
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sherief Abd-Elsalam

Investigators

  • Principal Investigator: Nadia Ezzat Helal, Ass. Prof., Forensic medicine Department- Tanta University
  • Principal Investigator: Ayman Nagy, ass. Prof., Forensic medicine Department- Tanta University
  • Principal Investigator: Ghada N. El-Sarnagawy, ass. Prof., Forensic medicine Department- Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2020

Primary Completion (ANTICIPATED)

December 1, 2030

Study Completion (ANTICIPATED)

December 10, 2030

Study Registration Dates

First Submitted

August 1, 2020

First Submitted That Met QC Criteria

August 1, 2020

First Posted (ACTUAL)

August 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 5, 2020

Last Update Submitted That Met QC Criteria

August 1, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ghada protocol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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