Paracetamol Toxicity in Septic Patients

Paracetamol-induced Liver Toxicity in Septic Patients

Status

Suspended

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01182974

Enrollment

Registered

2010-08-17

Start date

2010-08-31

Completion date

2011-08-31

Last updated

2011-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever, Sepsis

Keywords

fever in severe sepsis

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.

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.

Interventions

DRUGparacetamol

1 gr of paracetamol PO/PZ/PR

DRUGdypirone

1 gr PO/PZ/PR/IM

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
paracetamol induced liver toxicity	every six months	defined as ALT and/or AST \> 1000 or reduction in glutathione below 50% of base line

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026