Trial no.:	PACTR202607643375797	Date of Registration:	07/07/2026
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Comparing the Efficacy and Safety of the Standard 21-hour N-Acetylcysteine Regimen versus the Scottish and Newcastle Acetylcysteine Protocol (SNAP) 12-hour Regimen in Patients with Acute Paracetamol Toxicity. A randomizd controlled trial.

Official scientific title

Comparing the Efficacy and Safety of the Standard 21-hour N-Acetylcysteine Regimen versus the Scottish and Newcastle Acetylcysteine Protocol (SNAP) 12-hour Regimen in Patients with Acute Paracetamol Toxicity. A randomizd controlled trial.

Brief summary describing the background and objectives of the trial

Paracetamol (acetaminophen) overdose remains a major global public health concern, frequently resulting in emergency hospital admissions and representing the leading cause of acute liver failure in many countries. The toxic metabolite N-acetyl-p-benzoquinone imine (NAPQI) mediates hepatocellular injury, and the timely administration of N-acetylcysteine (NAC) is highly effective in mitigating this risk. When initiated within 8 hours of a single acute overdose, NAC dramatically reduces the risk of acute liver failure or death. This study aims to evaluate the comparative efficacy and safety of the standard 21-hour N-acetylcysteine (NAC) regimen versus the Scottish and Newcastle Acetylcysteine Protocol (SNAP) 12-hour regimen in preventing liver injury and reducing adverse drug reactions in patients admitted with acute paracetamol toxicity.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Injury, Occupational Diseases, Poisoning

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Drugs

Anticipated trial start date

01/11/2025

Actual trial start date

01/11/2025

Anticipated date of last follow up

01/07/2026

Actual Last follow-up date

Anticipated target sample size (number of participants)

142

Actual target sample size (number of participants)

Recruitment status

Recruiting

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification	Sealed opaque envelopes	Masking/blinding used	Care giver/Provider,Outcome Assessors

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Control Group	Nacetyl cysteine intravenous solution standard 21 hour NAC regimen	standard 21-hour NAC regimen, which consists of a first dose of 150 mg/kg body weight over 1 hour, a second dose of 50 mg/kg over 4 hours, and a third dose of 100 mg/kg over 16 hours..	21hour once for each case	standard 21-hour NAC regimen, which consists of a first dose of 150 mg/kg body weight over 1 hour, a second dose of 50 mg/kg over 4 hours, and a third dose of 100 mg/kg over 16 hours..	71	Active-Treatment of Control Group
Experimental Group	N acetyl cysteine intravenous solution 12 hour regimen	Group B (Experimental Group) will receive the SNAP 12-hour NAC regimen, which includes a first dose of 100 mg/kg NAC in 200 mL of 5% Glucose or 0.9% Saline over 2 hours, followed by a second dose of 200 mg/kg NAC in 1000 mL of 5% Glucose or 0.9% Saline over 10 hours.	For 12 hour single dose (Scottish Newcastle Acetylcysteine Protocol (SNAP) 12 hour regimen)	Group B (Experimental Group) will receive the SNAP 12-hour NAC regimen, which includes a first dose of 100 mg/kg NAC in 200 mL of 5% Glucose or 0.9% Saline over 2 hours, followed by a second dose of 200 mg/kg NAC in 1000 mL of 5% Glucose or 0.9% Saline over 10 hours.	71

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
Patients aged 12 years or older (male and female) presenting with acute paracetamol toxicity requiring N-acetylcysteine treatment as per national guidelines (e.g., TOXBASE criteria). This includes patients admitted within 8 hours of a single acute paracetamol overdose, or presenting with a staggered overdose or uncertain time of ingestion requiring NAC.	patients aged less than 12 years old 2- known hypersensitivity or contraindication to N-acetylcysteine 3-individuals with pre-existing severe liver disease (e.g., cirrhosis, chronic liver failure) or other chronic comorbidities that may confound liver function assessment (e.g., chronic kidney disease, severe cardiovascular disease, diabetes, chronic pulmonary disease).	Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s)	12 Year(s)	70 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

23/10/2025

Ethical commitee of faculty of medicine of armed forces

Ethics Committee Address
Street address	City	Postal code	Country
El geish street	tanta	31527	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	the study will be the incidence of hepatotoxicity, defined as an Alanine Aminotransferase (ALT) level greater than 1000 U/L within 48-72 hours of admission.	Within 48-72hour from admission
Secondary Outcome	-The secondary outcomes will include the incidence and severity of adverse drug reactions (ADRs) to NAC (e.g., anaphylactoid reactions, nausea, vomiting), the duration of hospital stay, the need for intensive care unit (ICU) admission or intubation, the mortality rate, changes in liver function tests (ALT, AST, Bilirubin) and INR over time, the total dose of vasopressors required (if applicable), and arterial blood pressure and arterial blood gas parameters.	Till discharge

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Tanta university poison control center	El geish streett	tanta	31527	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Hafsa salah Gheat	El geish street	tanta	331527	Egypt

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Self sponsor	El geish	tanta	31527	Egypt	Individual

COLLABORATORS
Name	Street address	City	Postal code	Country
Hafsa salah gheat	El geish	tanta	3527	Egypt
Mohamed fouad hassann	elgeish	tanta	31527	Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Hafsa Gheat	hafsasalah66@gmail.com	01123558563	El geish
City	Postal code	Country	Position/Affiliation
Tanta	31572	Egypt	lecturer
Role	Name	Email	Phone	Street address
Scientific Enquiries	Marwa Mubarak	Marwa.ahmed@med.tanta.edu.eg	0403322465	El estad street
City	Postal code	Country	Position/Affiliation
Tanta	3157	Egypt	lecturer
Role	Name	Email	Phone	Street address
Public Enquiries	Hafsa salah	hafsasalah66@gmail.com	01123558563	Elgeish
City	Postal code	Country	Position/Affiliation
Tanta	31572	Egypt	lecturer

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	“Data obtained through this study may be provided to qualified researchers with academic interest in urology. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.	Informed Consent Form,Statistical Analysis Plan,Study Protocol	“Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.”	““Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
please contact clinicalresearchsupportcenter@ucdenver.edu.”	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Trial Information	Trial description	29/06/2026	Adding Brief summary on background	This study aims to evaluate the comparative efficacy and safety of the standard 21-hour N-acetylcysteine (NAC) regimen versus the Scottish and Newcastle Acetylcysteine Protocol (SNAP) 12-hour regimen in preventing liver injury and reducing adverse drug reactions in patients admitted with acute paracetamol toxicity.	Paracetamol (acetaminophen) overdose remains a major global public health concern, frequently resulting in emergency hospital admissions and representing the leading cause of acute liver failure in many countries. The toxic metabolite N-acetyl-p-benzoquinone imine (NAPQI) mediates hepatocellular injury, and the timely administration of N-acetylcysteine (NAC) is highly effective in mitigating this risk. When initiated within 8 hours of a single acute overdose, NAC dramatically reduces the risk of acute liver failure or death. This study aims to evaluate the comparative efficacy and safety of the standard 21-hour N-acetylcysteine (NAC) regimen versus the Scottish and Newcastle Acetylcysteine Protocol (SNAP) 12-hour regimen in preventing liver injury and reducing adverse drug reactions in patients admitted with acute paracetamol toxicity.
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	07/07/2026	PACTR Admin	Control Group, Nacetyl cysteine intravenous solution , standard 21-hour NAC regimen, which consists of a first dose of 150 mg/kg body weight over 1 hour, a second dose of 50 mg/kg over 4 hours, and a third dose of 100 mg/kg over 16 hours.., 21hour once for each case, standard 21-hour NAC regimen, which consists of a first dose of 150 mg/kg body weight over 1 hour, a second dose of 50 mg/kg over 4 hours, and a third dose of 100 mg/kg over 16 hours.., 71, Active-Treatment of Control Group	Control Group, Nacetyl cysteine intravenous solution standard 21 hour NAC regimen, standard 21-hour NAC regimen, which consists of a first dose of 150 mg/kg body weight over 1 hour, a second dose of 50 mg/kg over 4 hours, and a third dose of 100 mg/kg over 16 hours.., 21hour once for each case, standard 21-hour NAC regimen, which consists of a first dose of 150 mg/kg body weight over 1 hour, a second dose of 50 mg/kg over 4 hours, and a third dose of 100 mg/kg over 16 hours.., 71, Active-Treatment of Control Group
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Intervention	Intervention List	29/06/2026	Changing the intervention name in experimental group (it is the same drug in both groups but the difference in duration of administration)	Experimental Group, N acetyl cysteine intravenous solution , Group B (Experimental Group) will receive the SNAP 12-hour NAC regimen, which includes a first dose of 100 mg/kg NAC in 200 mL of 5% Glucose or 0.9% Saline over 2 hours, followed by a second dose of 200 mg/kg NAC in 1000 mL of 5% Glucose or 0.9% Saline over 10 hours., For 12 hour single dose , Group B (Experimental Group) will receive the SNAP 12-hour NAC regimen, which includes a first dose of 100 mg/kg NAC in 200 mL of 5% Glucose or 0.9% Saline over 2 hours, followed by a second dose of 200 mg/kg NAC in 1000 mL of 5% Glucose or 0.9% Saline over 10 hours., 71,	Experimental Group, N acetyl cysteine intravenous solution 12 hour regimen , Group B (Experimental Group) will receive the SNAP 12-hour NAC regimen, which includes a first dose of 100 mg/kg NAC in 200 mL of 5% Glucose or 0.9% Saline over 2 hours, followed by a second dose of 200 mg/kg NAC in 1000 mL of 5% Glucose or 0.9% Saline over 10 hours., For 12 hour single dose (Scottish Newcastle Acetylcysteine Protocol (SNAP) 12 hour regimen), Group B (Experimental Group) will receive the SNAP 12-hour NAC regimen, which includes a first dose of 100 mg/kg NAC in 200 mL of 5% Glucose or 0.9% Saline over 2 hours, followed by a second dose of 200 mg/kg NAC in 1000 mL of 5% Glucose or 0.9% Saline over 10 hours., 71,
Section Name	Field Name	Date	Reason	Old Value	Updated Value
Funding Source	FundingSources List	18/05/2026	Name of the principal investigator	Self fundingsource, El geish street, tanta, 331527, Egypt, ,	Hafsa salah Gheat, El geish street, tanta, 331527, Egypt, Self Funded,

Pan African Clinical Trials Registry