Paracetamol Toxicity in Septic Patients

Phase 3

Suspended

• Conditions: Fever; Sepsis
• Interventions: Drug: dypirone; Drug: paracetamol

• Registration Number: NCT01182974
• Lead Sponsor: Barzilai Medical Center

Brief 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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-16
• Study First Submitted QC: 2010-08-16
• Study First Posted: 2010-08-17
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-01
• Last Update Posted: 2011-03-02
• Primary Completion: 2011-08
• Study Completion: 2011-08

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• age>18y

• hospitalized to int. med. dept. or ICU

• body temp>38 and one or more from the following:

  1. pulse>90 bpm
  2. resp. rate>20/min or PaCO2<32 mmHg
  3. WBC>12000 or <4000

• one of the following:

  1. hypotension
  2. disturbed end-organ perfusion (confusion, oliguria, lactic acidosis etc.)

Exclusion Criteria

• acute / chronic liver disease
• acute CNS disorder
• current isoniazid treatment
• alcoholism
• active malignancy
• pregnancy
• TPN or PPN

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control- dypirone treatment	dypirone	-
paracetamol treatment	paracetamol	-

Primary Outcome Measures

Name	Time	Method
paracetamol induced liver toxicity	every six months	defined as ALT and/or AST \> 1000 or reduction in glutathione below 50% of base line

Trial Locations

Locations (1)

Barzilai medical center; 🇮🇱 Ashkelon, Israel