NCT01182974

Paracetamol Toxicity in Septic Patients

Paracetamol-induced Liver Toxicity in Septic Patients

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Barzilai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Fever
• Sepsis

Interventions

Type	Name	Description
DRUG	paracetamol	1 gr of paracetamol PO/PZ/PR
DRUG	dypirone	1 gr PO/PZ/PR/IM

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2010-08-17
• Last updated: 2011-03-02

Locations

1 site across 1 country: Israel