Status:
SUSPENDED
Paracetamol Toxicity in Septic Patients
Lead Sponsor:
Barzilai Medical Center
Collaborating Sponsors:
Hadassah Medical Organization
Conditions:
Fever
Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 dypiron...
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 thera...
Eligibility Criteria
Inclusion
- age\>18y
- hospitalized to int. med. dept. or ICU
- body temp\>38 and one or more from the following:
- pulse\>90 bpm
- resp. rate\>20/min or PaCO2\<32 mmHg
- WBC\>12000 or \<4000
- one of the following:
- hypotension
- disturbed end-organ perfusion (confusion, oliguria, lactic acidosis etc.)
Exclusion
- acute / chronic liver disease
- acute CNS disorder
- current isoniazid treatment
- alcoholism
- active malignancy
- pregnancy
- TPN or PPN
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01182974
Start Date
August 1 2010
End Date
August 1 2011
Last Update
March 2 2011
Active Locations (1)
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1
Barzilai medical center
Ashkelon, Israel, 78278