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RecruitingNCT04499885Updated Aug 5, 2020

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

An interventional study of Paraffin oil gastric lavage and Gastric lavage with saline and sodium bicarbonate 8.4% in Toxicity, Drug, sponsored by Sherief Abd-Elsalam. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2020-08-05.

Sponsored by Sherief Abd-Elsalam · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Sex
All
01

Study summary

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

02

Conditions studied

  • Toxicity, Drug
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    • Patients with symptomatic acute aluminum phosphide poisoning

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (estimated)

Study arms

  • 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

  • Active comparator
    Saline gastric lavage

    Gastric lavage with saline and sodium bicarbonate

    Device: Gastric lavage with saline and sodium bicarbonate 8.4%

Interventions

  • DeviceParaffin oil gastric lavage

    Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution

    Also known as: Paraffin oil

  • DeviceGastric lavage with saline and sodium bicarbonate 8.4%

    Gastric lavage with saline and sodium bicarbonate 8.4%

    Also known as: Saline gastric lavage

05

What researchers measure

Primary outcomes

  1. Number of deaths

    The number of deaths

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04499885
Lead sponsor
Sherief Abd-Elsalam
Responsible party
Sherief Abd-Elsalam (Ass. Prof. Tropical Medicine, Tanta University) — Sponsor-investigator
First posted
Aug 5, 2020
Start date
Jun 1, 2020
Primary completion
Dec 1, 2030 (estimated)
Completion
Dec 10, 2030 (estimated)
Last update
Aug 5, 2020

Study contacts

Sherief Abd-Elsalam, ass. prof.
Contact
sheriefabdelsalam@yahoo.com
00201147773440
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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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