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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

Page last updated: August 23, 2015

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