Acute Liver Failure
Conditions
Keywords
hepatic failure, acute liver failure, acetylcysteine, randomized controlled trial, supportive care
Brief summary
This randomized controlled trial evaluates whether oral N-acetylcysteine (NAC), given alongside standard supportive care, improves survival and reduces mortality in patients with non-acetaminophen-induced acute liver failure (ALF), compared to supportive care alone. Secondary objectives are to assess NAC's effect on length of hospital stay and improvement in liver function tests. Sixty-two adult patients (18-60 years) will be randomized 1:1 to NAC or control, with outcomes assessed at 28 days (survival/mortality) and day 4 (liver function tests).
Detailed description
Acute liver failure carries high mortality, and in resource-limited settings like Pakistan, liver transplantation is often inaccessible, making pharmacologic adjuncts to supportive care important. Prior studies (Nabi et al. 2017; Mumtaz et al. 2009; Parkas et al. 2016) suggest oral NAC may improve survival and shorten hospital stay in non-acetaminophen ALF, though evidence remains limited. This trial will randomly assign eligible patients via computer-generated randomization to receive oral/NG NAC (140 mg/kg every 4 hours for 16 hours, then every 6-8 hours, continued for 3 days) plus standard supportive care, or standard supportive care alone. Standard care includes glucose monitoring, prophylactic antimicrobials, proton pump inhibitors, fluid/electrolyte management, anti-encephalopathy measures as needed, and fresh frozen plasma for bleeding. Patients will be followed for up to 28 days.
Interventions
DRUGN Acetyl Cysteine
Oral or nasogastric N-acetylcysteine administered at 140 mg/kg every 4 hours for the first 16 hours, followed by 140 mg/kg every 6-8 hours, continued for a total duration of 3 days, given in addition to standard supportive care.
Standard supportive care protocol for acute liver failure (glucose control, antimicrobials, PPIs, fluid/electrolyte management, anti-encephalopathy measures, FFP as needed).
Sponsors
King Edward Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly allocated 1:1 to receive either oral/NG N-acetylcysteine plus standard supportive care, or standard supportive care alone, and followed in parallel for outcome assessment through day 28.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, aged 18-60 years * Diagnosed with non-acetaminophen- induced acute hepatic failure (per operational definition/EASL criteria) * Etiology other than acetaminophen overdose (viral hepatitis HAV/HBV/HEV, non-acetaminophen drug-induced liver injury, or idiopathic) * No NAC treatment received for current episode prior to enrollment
Exclusion criteria
* History of chronic liver disease or cirrhosis * Prior severe cardiac, renal, neurological, or infectious disease that could confound outcomes * Prior liver transplant or current transplant candidacy * Known allergy/contraindication to NAC * Pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival/Mortality rate | 28 days after enrollment | Proportion of patients alive (survival) vs. deceased (mortality) at day 28. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | From admission to discharge or death (up to 28 days) | Lenght of Hospital stay from admission to death/discharge. |
Countries
Pakistan
Contacts
CONTACTSomia Iqtadar, FCPS
CONTACTZaeem Ahmad, MBBS
PRINCIPAL_INVESTIGATORSomia Iqtadar, FCPS
King Edward Medical University
Outcome results
None listed