A multicentre study of the safety and efficacy of N-acetylcysteine in the treatment of acute liver failure in paediatric patients not caused by acetaminophe

Completed

• Conditions: Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases; Digestive System; Acute liver failure

• Registration Number: ISRCTN36658311
• Lead Sponsor: King's College Hospital NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-12
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

Enrolment in PALF registry:
1. Evidence of acute liver injury
2. International normalised ratio (INR) greater than or equal to 1.5 or prothrombin time (PT) greater than or equal to 15 with encephalopathy, or INR greater than or equal to 2.0 or PT greater than or equal to 20 with or without encephalopathy
3. Aged less than 18 years, either sex
4. Informed consent, obtained from the patient or parent

Exclusion Criteria

1. Acute paracetomol toxicity
2. Patient on N-acetylcysteine or received N-acetylcysteine during the course of this illness
3. Pregnancy
4. Known malignancy
5. Patient is on a liver support device
6. Sepsis
7. Signs of cerebral herniation
8. Intractable hypotension

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of survival without liver transplant

Secondary Outcome Measures

Name	Time	Method
1. Length of intensive care unit and hospital stay<br>2. Number of organ systems failures