Drug Induced Liver Injury, Fever, Liver Failure, Liver Failure, Acute, Prevention & Control
Conditions
Keywords
Acetaminophen, Acetylcysteine, Antidotes
Brief summary
The purpose of this study is to compare the efficacy of the an N-acetyl-p-aminophenol (APAP, also known as acetaminophen) and N-acetylcysteine (NAC) combination versus an APAP-placebo combination as an anti-pyretic agent.
Detailed description
N-acetyl-p-aminophenol (APAP), or more commonly known as acetaminophen in the United States, accounts for more overdose and overdose deaths in the United States and United Kingdom than any other pharmaceutical agent. If N-acetylcysteine (NAC) is given within 8 to 10 hours of APAP ingestion, it has been shown to prevent serious liver failure and death in the setting of overdoses. Therefore, it may be beneficial to administer APAP in combination with NAC routinely to reduce rates of liver failure and death. Because NAC's main role is to reduce the accumulation of APAP's toxic metabolites, the concomitant administration of NAC should have no impact on the efficacy of APAP as an antipyretic and analgesic. Thus, we propose a single-center, non-inferiority randomized control study comparing the efficacy of the APAP-NAC combination as compared to APAP-placebo as an anti-pyretic agent.
Interventions
DRUGAPAP and NAC combination
APAP 650mg and NAC 600mg combination oral tablet administered once
DRUGAPAP and Placebo
APAP 650mg and Placebo combination oral tablet administered once
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* adults aged 18 to 75 years old * admitted to an inpatient unit at Columbia-Presbyterian Medical Center * fever defined as an oral temperature of 38.5°C
Exclusion criteria
* if oral temperature cannot be obtained * abnormal aminotransferase levels * prior adverse reaction to acetaminophen or N-acetylcysteine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in temperature reduction between participants who are administered combination N-acetyl-p-aminophenol and N-Acetylcysteine (APAP-NAC) versus combination APAP-placebo | 6 hours after study drug administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in liver function tests after study drug administration between participants who are administered combination N-acetyl-p-aminophenol and N-Acetylcysteine (APAP-NAC) versus combination APAP-placebo | Within 24 hours of study drug administration | Change in serum total protein (TP), albumin (Alb), total bilirubin (TB), direct bilirubin (DB), amino alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatate (AP) levels before and after the study drug administration. |
Countries
United States
Outcome results
None listed