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

Sponsor

Imperial College London (Other)

Overall Status

Recruiting

CT.gov ID

NCT03069300

Collaborator

(none)

Enrollment

Location

Arms

116

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholic Hepatitis Infection	Drug: N-acetyl cysteine (NAC)	Phase 3

Detailed Description

Randomised controlled trial, open label.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized controlled trialrandomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Mechanism of Action of N-acetylcysteine for Reducing the Risk of Infection in Alcoholic Hepatitis

Actual Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: prednisolone+NAC 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	Drug: N-acetyl cysteine (NAC) Other Names: NAC
No Intervention: prednisolone 40mg prednisolone for 28 days

Arm

Intervention/Treatment

Experimental: prednisolone+NAC

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

Drug: N-acetyl cysteine (NAC)

Other Names:

NAC

No Intervention: prednisolone

40mg prednisolone for 28 days

Outcome Measures

Primary Outcome Measures

Improvement in monocyte oxidative burst [24 hours]
Improvement in ex vivo monocyte oxidative burst [5 days]

Secondary Outcome Measures

Proportion of patients infected [28 days]
Infection will be defined in two ways: i. by new/change in intravenous antibiotic prescription and ii. published clinical and microbiological criteria for infection in the setting of liver disease
Proportion of patients infected [90 days]
Infection will be defined in two ways: i. by new/change in intravenous antibiotic prescription and ii. published clinical and microbiological criteria for infection in the setting of liver disease
Death [28 days]
Death [90 days]