N-ACetylcysteine to Reduce Infection and Mortality for Alcoholic Hepatitis (NACAH)

Imperial College London

Status and phase: Enrolling; Phase 3

Conditions: Infection; Alcoholic Hepatitis

Treatments: Drug: N-acetyl cysteine (NAC)

Study type: Interventional

Funder types: Other

Identifiers

NCT03069300

14SM2383

Details and patient eligibility

About

Recent data have suggested that monocyte oxidative burst defect is associated with the development of infection in patients with severe alcoholic hepatitis. One report found reduced 28 day mortality in patients treated with N-acetylcysteine combined with prednisolone when compared to prednisolone alone. The current study seeks to reveal whether the mechanism by which NAC reduces susceptibility to infection is through improvement of phagocyte oxidative burst.

Full description

Randomised controlled trial, open label.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 years or older

• Clinical alcoholic hepatitis:

  • Serum bilirubin >80umol/L
  • History of alcohol excess (>80g/day male, >60g/day female)
  • Less than 4 weeks since admission to hospital
  • Maddrey's discriminant function (DF) >32
  • Informed consent

Exclusion criteria

• Alcohol abstinence of >6 weeks prior to randomisation

• Duration of jaundice >3 months

• Other causes of liver disease including:

  • Evidence of viral hepatitis (hepatitis B or C)
  • Biliary obstruction
  • Hepatocellular carcinoma

• Evidence of current malignancy (except non-melanotic skin cancer)

• Previous entry into the study

• Patients with known hypersensitivity or previous reactions to NAC

• Pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

prednisolone+NAC

Experimental group

Description:

40mg prednisolone once a day for 28 days and 30 minutes of intravenous NAC at 150mg/kg in 250ml 5% dextrose solution followed by 4 hours of intravenous NAC at 50mg/kg in 500ml 5% dextrose solution, followed by 16 hours of intravenous NAC at 100 mg/kg in 1000ml 5% dextrose solution, followed by 4 days of intravenous NAC at 100mg/kg/day in 1000ml 5% dextrose solution

Treatment:

Drug: N-acetyl cysteine (NAC)

prednisolone

No Intervention group

Description:

40mg prednisolone for 28 days