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

August 16, 2010
March 1, 2011
August 2010
August 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01182974 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Paracetamol Toxicity in Septic Patients
Paracetamol-induced Liver Toxicity in Septic Patients

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Fever
  • Sepsis
  • Drug: paracetamol
    1 gr of paracetamol PO/PZ/PR
    Other Name: acetaminophen, acamol
  • Drug: dypirone
    1 gr PO/PZ/PR/IM
    Other Name: optalgin
  • Active Comparator: paracetamol treatment
    Intervention: Drug: paracetamol
  • Active Comparator: control- dypirone treatment
    Intervention: Drug: dypirone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
80
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01182974
1662CTIL
No
Albert Grinshpun, Barzilai medical center
Barzilai Medical Center
Hadassah Medical Organization
Principal Investigator: Albert Grinshpun Barziali medical center, Ashkelon
Barzilai Medical Center
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP