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Paracetamol Toxicity in Septic Patients

This study has suspended participant recruitment.
(Difficulty in patient enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01182974
First Posted: August 17, 2010
Last Update Posted: March 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hadassah Medical Organization
Information provided by:
Barzilai Medical Center
  Purpose
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 Intervention Phase
Fever Sepsis Drug: paracetamol Drug: dypirone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Paracetamol-induced Liver Toxicity in Septic Patients

Resource links provided by NLM:


Further study details as provided by Barzilai Medical Center:

Primary Outcome Measures:
  • paracetamol induced liver toxicity [ Time Frame: every six months ]
    defined as ALT and/or AST > 1000 or reduction in glutathione below 50% of base line


Estimated Enrollment: 80
Study Start Date: August 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: paracetamol treatment Drug: paracetamol
1 gr of paracetamol PO/PZ/PR
Other Name: acetaminophen, acamol
Active Comparator: control- dypirone treatment Drug: dypirone
1 gr PO/PZ/PR/IM
Other Name: optalgin

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01182974


Locations
Israel
Barzilai medical center
Ashkelon, Israel, 78278
Sponsors and Collaborators
Barzilai Medical Center
Hadassah Medical Organization
Investigators
Principal Investigator: Albert Grinshpun Barziali medical center, Ashkelon
  More Information

Responsible Party: Albert Grinshpun, Barzilai medical center
ClinicalTrials.gov Identifier: NCT01182974     History of Changes
Other Study ID Numbers: 1662CTIL
First Submitted: August 16, 2010
First Posted: August 17, 2010
Last Update Posted: March 2, 2011
Last Verified: March 2011

Keywords provided by Barzilai Medical Center:
fever in severe sepsis

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics