The study will examine all levels of cytokines and nitrotyrosine in patients with acetaminophen overdose. Comparisons will be made between cytokine levels and nitrotyrosine levels and the severity of the liver injury.

Condition	Intervention
Liver Dysfunction	Procedure: Blood Sampling

Further Study Details: 

Expected Total Enrollment:  200

The data obtained from this study will provide the framework for understanding the role of inflammation in the mediation of acetaminophen toxicity in man. Time profiles for inflammatory mediators and correlations between hepatoxicity and the presence of nitrotyrosine and cytokines in plasma will be generated. This data is a prerequisite for the development of new therapies that would inhibit the formation of key inflammatory mediators in acetaminophen toxicity. Of particular interest is the development of therapies that would be effective beyond the timepoint for which NAC is traditionally thought to be of greatest benefit. Patients who would benefit from such therapies include children who are victims of chronic acetaminophen poisoning with therapeutic intent, and patients who present late (i.e., greater than 16 hours after acetaminophen overdose) for medical evaluation following acetaminophen overdose. By understanding the role of inflammatory processes in the development of toxicity, novel therapies may be developed that will improve the management and survival of the complicated acetaminophen overdose patient.

Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Males and females of any age admitted to participating site for acetaminophen overdose (acute or chronic)

Exclusion Criteria:

• Patients who are unable to tolerate study procedures

Please refer to this study by ClinicalTrials.gov identifier  NCT00147407

Arkansas
      Arkansas Children''''s Hospital, Little Rock,  Arkansas,  72202,  United States; Recruiting
Kentucky
      Kosair Children''''s Hospital, Louisville,  Kentucky,  40202,  United States; Recruiting
Michigan
      Children''''s Hospital of Michigan, Detroit,  Michigan,  48201,  United States; Recruiting
Missouri
      Children''''s Mercy Hospital, Kansas City,  Missouri,  64108,  United States; Recruiting
North Carolina
      University of North Carolina- Chapel Hill, Chapel Hill,  North Carolina,  27599,  United States; Recruiting
Ohio
      Rainbow Babies and Children''''s Hospital, Cleveland,  Ohio,  44106,  United States; Recruiting
Texas
      Texas Children''''s Hospital, Houston,  Texas,  77030,  United States; Recruiting

Study chairs or principal investigators

Laura James, M.D.,  Principal Investigator,  Arkansas Children’s Hospital   

Study ID Numbers:  PPRU-10368
Last Updated:  September 6, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00147407
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13