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

Sponsor
Sherief Abd-Elsalam (Other)
Overall Status
Recruiting
CT.gov ID
NCT04499885
Collaborator
(none)
62
Enrollment
1
Location
2
Arms
126.3
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Paraffin oil gastric lavage
  • Device: Gastric lavage with saline and sodium bicarbonate 8.4%
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning: A Randomized Controlled Clinical Trial
Actual Study Start Date :
Jun 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2030
Anticipated Study Completion Date :
Dec 10, 2030

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of deaths [6 months]

      The number of deaths

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sherief Abd-Elsalam Tanta Egypt

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sherief Abd-Elsalam, Ass. Prof. Tropical Medicine, Tanta University
    ClinicalTrials.gov Identifier:
    NCT04499885
    Other Study ID Numbers:
    • ghada protocol
    First Posted:
    Aug 5, 2020
    Last Update Posted:
    Aug 5, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Poisoning
    Drug-Related Side Effects and Adverse Reactions
    Mineral Oil

    Study Results

    No Results Posted as of Aug 5, 2020