Back to results

Effectiveness of N-acetyl Cysteine, Acetyl L- Carnitine and Medicated Paraffin Oil in Aluminium Phosphide Poisoning

Primary Purpose

the Study Focus to Improve the Standard of Care Used for Aluminuim Phosphide Poisoning and to Save Patients With the Minimal Organ Damage

Status

Unknown status

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

N-acetyl cysteine

acetyl L-carnitine

medicated paraffin oil

Sodium Bicarbonate Powder and ondansetron

About this trial

This is an interventional supportive care trial for the Study Focus to Improve the Standard of Care Used for Aluminuim Phosphide Poisoning and to Save Patients With the Minimal Organ Damage focused on measuring N-acetyl cysteine, Acety L- carnitine, paraffin oil, aluminium phosphide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

All adult patients with history of acute intoxication with AlP presented to the Poison Control Center of Ain-Shams University hospitals during the period of the study

Exclusion Criteria:

Patients less than 18
Patients presented with delay time exceeding 12 hours after acute intoxication.
Patients with history of cardiac, renal or hepatic diseases.
Patients who show hypersensitivity to NAC, ALCAR or paraffin oil.

Sites / Locations

Poison Control Center of Ain-Shams University hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Arm Label

control group

N- acetyl cysteine grouo

Acetyl L-carnitine group

Medicated paraffin oil group

Arm Description

this group will have the standard and routine therapy of treatment of acute Aluminium Phosphide poisoning immediately after admission according to PCCA guidelines

N-acetyl cysteine will be given at dose of 300mg/kg/d IV in the first day then 150 mg/kg/d IV in addition to standard of care according to PCCA guidelines

Acetyl L-carnitine will be given at dose of 50 mg/kg IV once to be followed by additional doses of 15 mg/kg IV q4hr infused over 30 min. standard of care according to PCCA guidelines will also be provided

Gastric decontamination with sodium bicarbonate (NaHCO3; 44 mEq, orally) and medicated paraffin oil (200 mL) will be administered in addition to standard of care according to PCCA guidelines

Outcomes

Primary Outcome Measures

mortality rate reduction

the primary end point is to lower the mortality rate for patients poisoned with aluminium phosphide pellets

organ damage reduction

another primary end point is to reduce organ damage and injury for survivors

Secondary Outcome Measures

Full Information

NCT ID

NCT04509258

First Posted

August 9, 2020

Last Updated

August 9, 2020

Sponsor

Cairo University

Collaborators

Ain Shams University hospitals

1. Study Identification

Unique Protocol Identification Number

NCT04509258

Brief Title

Effectiveness of N-acetyl Cysteine, Acetyl L- Carnitine and Medicated Paraffin Oil in Aluminium Phosphide Poisoning

Official Title

Comparative Effectiveness of N-acetyl Cysteine, Acetyl L- Carnitine and Medicated Paraffin Oil in Acute Aluminium Phosphide Poisoning: A Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 2020 (Anticipated)

Primary Completion Date

October 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

Collaborators

Ain Shams University hospitals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Aluminium Phosphide is a pesticide used in developing countries to prevent rodents and pests from spoiling the harvested grains. it is presented as tablets which can be administered accidently to humans or for committing suicide. this pesticide is fatal even in small concentration as mortality rate can reach 75- 100% of cases. in this study researchers tried to add some supplements to the routine treatment to improve and decrease the fatality rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

the Study Focus to Improve the Standard of Care Used for Aluminuim Phosphide Poisoning and to Save Patients With the Minimal Organ Damage

Keywords

N-acetyl cysteine, Acety L- carnitine, paraffin oil, aluminium phosphide

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

this group will have the standard and routine therapy of treatment of acute Aluminium Phosphide poisoning immediately after admission according to PCCA guidelines

Arm Title

N- acetyl cysteine grouo

Arm Type

Active Comparator

Arm Description

N-acetyl cysteine will be given at dose of 300mg/kg/d IV in the first day then 150 mg/kg/d IV in addition to standard of care according to PCCA guidelines

Arm Title

Acetyl L-carnitine group

Arm Type

Active Comparator

Arm Description

Arm Title

Medicated paraffin oil group

Arm Type

Active Comparator

Arm Description

Gastric decontamination with sodium bicarbonate (NaHCO3; 44 mEq, orally) and medicated paraffin oil (200 mL) will be administered in addition to standard of care according to PCCA guidelines

Intervention Type

Drug

Intervention Name(s)

N-acetyl cysteine

Intervention Description

a drug which can have an off label use as an antidot for aluminium phosphide poisoning in addition to sodium bicarbonate and ondansetron as standard of care

Intervention Type

Dietary Supplement

Intervention Name(s)

acetyl L-carnitine

Intervention Description

Naturallu occuring amino acid derivative which can be taken as a dietary supplement involves in mitochondrial function and energy production and is suggested to have a role in lowering organ damage resulting from aluminium phosphide poisonong in addition to sodium bicarbonate and ondansetron as standard of care

Intervention Type

Drug

Intervention Name(s)

medicated paraffin oil

Intervention Description

refined mixture of liquid hydrocarbons which used as laxative and is suggested to reduce absorption of aluminium phosphide if taken within two hours of administration of the toxin in addition to sodium bicarbonate and ondansetron as standard of care

Intervention Type

Drug

Intervention Name(s)

Sodium Bicarbonate Powder and ondansetron

Intervention Description

standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide

Primary Outcome Measure Information:

Title

mortality rate reduction

Description

the primary end point is to lower the mortality rate for patients poisoned with aluminium phosphide pellets

Time Frame

1 year

Title

organ damage reduction

Description

another primary end point is to reduce organ damage and injury for survivors

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All adult patients with history of acute intoxication with AlP presented to the Poison Control Center of Ain-Shams University hospitals during the period of the study Exclusion Criteria: Patients less than 18 Patients presented with delay time exceeding 12 hours after acute intoxication. Patients with history of cardiac, renal or hepatic diseases. Patients who show hypersensitivity to NAC, ALCAR or paraffin oil.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mahmoud Sakr, PhD

Phone

+201117922833

mahmoud.sakr@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hanan Abdel Wahab, Master's

Phone

+201062261010

hanan.abdelwahab@yahoo.com

Facility Information:

Facility Name

Poison Control Center of Ain-Shams University hospitals

City

Cairo

State/Province

Abbasya

ZIP/Postal Code

11311

Country

Egypt

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Walaa Abdel Hamid, PhD

Phone

+201062261010

walaa.abdelhamid@gmail.com

First Name & Middle Initial & Last Name & Degree

Dalia Zaafar, PhD

Phone

+201117922833

dr.moda88@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

individual paticipant data is decided not to be shared for the privacy of the patients as patients in each group will be coded in numbers instead of their names

Learn more about this trial

Effectiveness of N-acetyl Cysteine, Acetyl L- Carnitine and Medicated Paraffin Oil in Aluminium Phosphide Poisoning

We'll reach out to this number within 24 hrs