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Paracetamol Toxicity in Septic Patients

Sponsor
Barzilai Medical Center (Other)
Overall Status
Suspended
CT.gov ID
NCT01182974
Collaborator
Hadassah Medical Organization (Other)
80
Enrollment
1
Location
2
Arms
12
Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
Paracetamol-induced Liver Toxicity in Septic Patients
Study Start Date :
Aug 1, 2010
Anticipated Primary Completion Date :
Aug 1, 2011
Anticipated Study Completion Date :
Aug 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: paracetamol treatment

Drug: paracetamol
1 gr of paracetamol PO/PZ/PR
Other Names:
  • acetaminophen, acamol

    		•
    Active Comparator: control- dypirone treatment

    Drug: dypirone
    1 gr PO/PZ/PR/IM
    Other Names:
  • optalgin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. paracetamol induced liver toxicity [every six months]

      defined as ALT and/or AST > 1000 or reduction in glutathione below 50% of base line

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barzilai medical center Ashkelon Israel 78278

    Sponsors and Collaborators

    • Barzilai Medical Center
    • Hadassah Medical Organization

    Investigators

    • Principal Investigator: Albert Grinshpun, Barziali medical center, Ashkelon

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01182974
    Other Study ID Numbers:
    • 1662CTIL
    First Posted:
    Aug 17, 2010
    Last Update Posted:
    Mar 2, 2011
    Last Verified:
    Mar 1, 2011
    Keywords provided by , ,
    fever in severe sepsis
    Additional relevant MeSH terms:
    Sepsis
    Acetaminophen

    Study Results

    No Results Posted as of Mar 2, 2011