Paracetamol Toxicity in Septic Patients
The investigators will examine the toxicity of therapeutic doses of paracetamol in patients in severe sepsis. Patients with fever and severe sepsis will be randomized to receive paracetamol or dypirone. The investigators will monitor blood glutathione and liver enzymes to look for potential toxicity.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Paracetamol-induced Liver Toxicity in Septic Patients|
- paracetamol induced liver toxicity [ Time Frame: every six months ] [ Designated as safety issue: No ]defined as ALT and/or AST > 1000 or reduction in glutathione below 50% of base line
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||August 2011|
|Estimated Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: paracetamol treatment||
1 gr of paracetamol PO/PZ/PR
Other Name: acetaminophen, acamol
|Active Comparator: control- dypirone treatment||
1 gr PO/PZ/PR/IM
Other Name: optalgin
Paracetamol is metabolized in liver using the glutathione system. This detoxification system is depressed during severe illness such as sepsis, trauma etc. The study will examine the toxicity of therapeutic doses of paracetamol in patients in severe sepsis. We believe that during sepsis, paracetamol metabolites are not fully detoxified and therefore are toxic to the patient.
Patients with fever and severe sepsis will be randomized to receive paracetamol or dypirone. The investigators will monitor blood glutathione (as a surrogate marker for liver glutathione), liver enzymes and various clinical data (such as length of hospitalization) to look for a potential toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182974
|Barzilai medical center|
|Ashkelon, Israel, 78278|
|Principal Investigator:||Albert Grinshpun||Barziali medical center, Ashkelon|