NCT04724655

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2021

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

January 19, 2021

Last Update Submit

June 6, 2022

Conditions

Aluminum Phosphide Poisoning

Outcome Measures

Primary Outcomes (1)

  • death

    72 hours

Study Arms (3)

control group

OTHER

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

Drug: standard treatmentOther: gastric lavage with saline and bicarbonate

paraffin group

ACTIVE COMPARATOR

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

Other: gastric lavage with paraffin oil and bicarbonateDrug: standard treatment

coconut group

ACTIVE COMPARATOR

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

Other: gastric lavage with coconut oil and bicarbonateDrug: standard treatment

Interventions

gastric lavage with paraffin oil and bicarbonateOTHER

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
gastric lavage with coconut oil and bicarbonateOTHER

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
standard treatmentDRUG

inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate

coconut groupcontrol groupparaffin group
gastric lavage with saline and bicarbonateOTHER

Gastric lavage with saline and sodium bicarbonate 8.4% then aspiration will be done after 3-5 min through nasogastric tube

control group

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tantau

Tanta, Egypt

Location

MeSH Terms

Interventions

Gastric LavageMineral OilBicarbonatesCoconut OilSodium Chloride

Intervention Hierarchy (Ancestors)

Therapeutic IrrigationInvestigative TechniquesPetrolatumHydrocarbonsOrganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsAnionsIonsElectrolytesDietary FatsFatsLipidsPlant OilsOilsChloridesHydrochloric AcidChlorine CompoundsSodium Compounds

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
faculty of medicine,tanta university,Tanta Elgeesh street,qism 2,Egypt

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 26, 2021

Study Start

January 1, 2021

Primary Completion

June 30, 2021

Study Completion

September 15, 2021

Last Updated

June 8, 2022

Record last verified: 2022-06

Locations

EG(1)