NCT04499885

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
56mo left

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Jun 2020Dec 2030

Study Start

First participant enrolled

June 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2030

Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

10.5 years

First QC Date

August 1, 2020

Last Update Submit

August 1, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of deaths

    The number of deaths

    6 months

Study Arms (2)

Paraffin oil gastric lavafe

ACTIVE COMPARATOR

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

Device: Paraffin oil gastric lavage

Saline gastric lavage

ACTIVE COMPARATOR

Gastric lavage with saline and sodium bicarbonate

Device: Gastric lavage with saline and sodium bicarbonate 8.4%

Interventions

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

Also known as: Paraffin oil
Paraffin oil gastric lavafe

Gastric lavage with saline and sodium bicarbonate 8.4%

Also known as: Saline gastric lavage
Saline gastric lavage

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with symptomatic acute aluminum phosphide poisoning

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Gastric Lavage

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Therapeutic IrrigationInvestigative Techniques

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherief Abd-Elsalam, ass. prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

August 1, 2020

First Posted

August 5, 2020

Study Start

June 1, 2020

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 10, 2030

Last Updated

August 5, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations