Treatment using N-acetyl cysteine (Injection) to reduce occurrence of muscle weakness and death in patients admitted with organophosphate (OP) pesticide poisoning.

A randomized controlled trial on N-acetyl cysteine in reducing the incidence of Intermediate syndrome (IMS) and in-hospital mortality in patients admitted with organophosphate (OP) pesticide poisoning - NACSTOP

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/09/028060

Enrollment

146

Registered

2020-09-25

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: T600- Toxic effect of organophosphate and carbamate insecticides

Interventions

Intervention1: n- acetyl cysteine: 1 gram of N-acetyl cysteine in 50 ml of normal saline intravenously once daily for 3 days Control Intervention1: Placebo: 50 ml of normal saline intravenously once d

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria The diagnosis of Organophosphate Poisoning made on the basis of typical clinical toxidrome of cholinergic and nicotinic manifestations and Reliable identification of the compound ingested on the basis of the container brought by the patients attendants or A subsequent confirmation of significant exposure based on suppression of serum pseudocholinesterase levels to less than 1000 U per L

Exclusion criteria

Exclusion criteria: Exclusion criteria: Presentation more than 48 hours of having consumed the organophosphate compound (late presenters) Those suspected to have a mixed or polysubstance overdose (other than ethanol and pyrethroid).

Design outcomes

Primary

Measure	Time frame
The primary outcome measure was incidence of Intermediate Syndrome (IMS).Timepoint: At baseline, day 3 day 5 and discharge	—

Secondary

Measure	Time frame
g. Incidence of complications of prolonged hospitalization i. Incidence of ventilator associated pneumonia (VAP). ii. Incidence of thrombophlebitis. iii. Incidence of deep vein thrombosis (DVT). iv. Incidence of pressure ulcers. Timepoint: within discharge from hospital;h. Cost of treatment (Direct medical cost alone Ã¢â?¬â?? hospital and pharmacy bill).Timepoint: within discharge from hospital;i. Incidence of adverse reactions associated with N-acetyl cysteine.Timepoint: On day 3, day 5 and at discharge from hospital;a. Incidence of mortality.Timepoint: At discharge from hospital;b. Length of hospital stay from day of admission in the emergency department.Timepoint: from admission to discharge from hospital;c. Total atropine usage from admission till discharge.Timepoint: within discharge from hospital;d. Mechanical ventilation i. Proportion of study patients requiring mechanical ventilation. ii. Duration of mechanical ventilation. Timepoint: from admission to discharge from hospital;e. ICU admission i. Proportion of study patients requiring ICU admission. ii. Duration of ICU stay. Timepoint: from admission to discharge from hospital;f. Incidence organophosphate related complications i. Incidence of delayed organophosphate encephalopathy (DOPE). Timepoint: within discharge from hospital	—

Measure

Time frame

g. Incidence of complications of prolonged hospitalization i. Incidence of ventilator associated pneumonia (VAP). ii. Incidence of thrombophlebitis. iii. Incidence of deep vein thrombosis (DVT). iv. Incidence of pressure ulcers. Timepoint: within discharge from hospital;h. Cost of treatment (Direct medical cost alone Ã¢â?¬â?? hospital and pharmacy bill).Timepoint: within discharge from hospital;i. Incidence of adverse reactions associated with N-acetyl cysteine.Timepoint: On day 3, day 5 and at discharge from hospital;a. Incidence of mortality.Timepoint: At discharge from hospital;b. Length of hospital stay from day of admission in the emergency department.Timepoint: from admission to discharge from hospital;c. Total atropine usage from admission till discharge.Timepoint: within discharge from hospital;d. Mechanical ventilation i. Proportion of study patients requiring mechanical ventilation. ii. Duration of mechanical ventilation. Timepoint: from admission to discharge from hospital;e. ICU admission i. Proportion of study patients requiring ICU admission. ii. Duration of ICU stay. Timepoint: from admission to discharge from hospital;f. Incidence organophosphate related complications i. Incidence of delayed organophosphate encephalopathy (DOPE). Timepoint: within discharge from hospital

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Countries

India

Contacts

Public ContactCatharine Paul

Christian Medical College, Vellore

iramya77@yahoo.com9865703823

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026