The Role of N-acetylcysteine as a Novel Adjuvant Treatmen... | NCT05927259

Studies
The Role of N-acetylcysteine as a Novel Adjuvant Treatment in Acute Organophosphorus Pesticide Poisoning

NCT05927259

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Jul 3, 2023Actual

Enrollment

40Actual

Phase

Early Phase 1

Conditions

Acute Organophosphorus Poisoned Patients

Interventions

n acetyl cysteine
standard treatment

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

May 1, 2023Actual

Completion Date

Jun 1, 2023Actual

First Submitted Date

Jun 22, 2023

First Submission Date that Met QC Criteria

Jun 22, 2023

First Posted Date

Jul 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2023

Last Update Posted Date

Jul 3, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

All patients admitted in the ICU of the PCC-ASUH due to acute poisoning by acute organophosphorus poisoning will be included in the study. The diagnosis of intoxication will be based on history of acute exposure , clinical examination and laboratory investigations. Patients will be randomly allocated into 2 equal groups.

Group 1 -. Patients who will receive (conventional treatment of acute organophosphorus poisoning plus NAC) and Group 2 - Patients who will receive conventional treatment only

Detailed Description

40 patients with acute organophosphorus poisoning will be randomly assigned as control groups and study group in a 1:1 ratio ( 20 patients in each group). The diagnosis of acute organophosphorus intoxication will be based on history of acute exposure, clinical examination and laboratory investigations. Patients will be randomly allocated into 2 equal groups.

Group 1 - Patients who will receive (conventional treatment of acute organophosphorus poisoning plus NAC) Group 2 - Patients who will receive conventional treatment only

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group	Active Comparator	Patients who will receive (conventional treatment of acute organophosphorus poisoning plus NAC)	Drug: n acetyl cysteine Drug: standard treatment
control group	Other	Patients who will receive conventional treatment only	Drug: standard treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
n acetyl cysteine	Drug	A patients received NAC 140 mg/Kg IV infusion (as a loading dose), then 70 mg/KgIV infusion every 4 hours up to 17 doses	study group

Measure	Description	Time Frame
mortality		72 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients (above 16 years) admitted to the ICU of the PCC-ASUH due to acute poisoning by acute organophosphorus poisoning will be included in the study. The diagnosis of intoxication will be based on history of acute exposure, clinical examination and laboratory investigations. -

Exclusion Criteria:

Based on the possibility of alteration in measured parameters and/or biomarkers, patients below 16 years or above 60 years Patients with history of diabetes, cardiac disease, respiratory, renal disease and hepatic disease.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sarah S Mohammed	faculty of medicine ain shams university	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
faculty of medicine Ain shams university		Cairo	None Selected	11566	Egypt
Faculty of Medicine

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000111	Acetylcysteine
D001285	Atropine
D010091	Oximes

Ancestor Terms

ID	Term
D003545	Cysteine
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

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Browse Branches

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