Paracetamol Toxicity in Septic Patients

• Status: Suspended
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barzilai Medical Center
• Collaborator: Hadassah Medical Organization
• Treatments: Acetaminophen

Criteria

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