Paracetamol Toxicity in Septic Patients
Information source: Barzilai Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fever; Sepsis
Intervention: paracetamol (Drug); dypirone (Drug)
Phase: Phase 3
Status: Suspended
Sponsored by: Barzilai Medical Center Official(s) and/or principal investigator(s): Albert Grinshpun, Principal Investigator, Affiliation: Barziali medical center, Ashkelon
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.
Clinical Details
Official title: Paracetamol-induced Liver Toxicity in Septic Patients
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: paracetamol induced liver 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Barzilai medical center, Ashkelon 78278, Israel
Additional Information
Starting date: August 2010
Last updated: March 1, 2011
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