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Clinical effects of N-acetylcysteine on acute kidney injury and other serious morbidities in children with snake envenomation.

Clinical effects of N-acetylcysteine on acute kidney injury and other serious morbidities in children with snake envenomation: A randomized double blind placebo controlled study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/10/007360
Enrollment
104
Registered
2016-10-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- All children aged less than 13 years of age, with a definite history of snake bite or circumstantial evidence consistent with snake envenomation(syndromic approach)

Interventions

Intervention1: N acetylcysteine: Intravenous NAC shall be given as 150 mg per kg loading in 3 mL per kg 0.9% saline over 60 min, followed by 50 mg per kg in 7 mL per kg 0.9% saline over 4 h Control I

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children aged less than 13 years of age, with a definite history of snake bite or circumstantial evidence consistent with snake envenomation(syndromic approach), attending the pediatric emergency services

Exclusion criteria

Exclusion criteria: 1. Children with chronic illnesses (e. g, chronic kidney disease or congenital heart disease) or decompensated cardiac failure. 2. Unknown bites. (Unknown bites shall be defined as bites in which the victims or their family members were sure it was not by a snake but something else). 3. Children without any local or systemic manifestations after snake bite. 4. Children with history of bronchial asthma or chronic liver disease. 5. Children already having AKI stage 3 (as per p-RIFLE classification)[8] or requiring dialysis at admission itself.

Design outcomes

Primary

MeasureTime frame
To compare the incidence and severity of acute kidney injury among children received N-acetylcysteine as compared to children not received N-acetylcysteine as adjunctive management for snake envenomationTimepoint: At PICU and Hospital discharge.

Secondary

MeasureTime frame
MortalityTimepoint: At 28 days;To compare the incidence and severity of local swelling, cellulitis, hemorrhagic and neurotoxic manifestations, stay in PICU, ventilation, hospital and doses of anti-snake venom vials, and adverse effect among children receiving N-acetylcysteine versus children not receiving N-acetylcysteine as adjunctive management for snake envenomation. Timepoint: At PICU and hospital discharge.

Countries

India

Contacts

Public ContactDR R RAMESH KUMAR

JIPMER

krramesh_iway@yahoo.co.in7373739142

Outcome results

None listed

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