Paracetamol Toxicity in Septic Patients

This study has suspended participant recruitment.
(Difficulty in patient enrollment)
Sponsor:
Collaborator:
Hadassah Medical Organization
Information provided by:
Barzilai Medical Center
ClinicalTrials.gov Identifier:
NCT01182974
First received: August 16, 2010
Last updated: March 1, 2011
Last verified: March 2011
  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: 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Albert Grinshpun, Barzilai medical center
ClinicalTrials.gov Identifier: NCT01182974     History of Changes
Other Study ID Numbers: 1662CTIL
Study First Received: August 16, 2010
Last Updated: March 1, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Barzilai Medical Center:
fever in severe sepsis

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on September 22, 2014