Paracetamol Toxicity in Septic Patients

Barzilai Medical Center

Status and phase

Suspended

Phase 3

Conditions

Fever

Sepsis

Treatments

Drug: paracetamol

Drug: dypirone

Study type

Interventional

Funder types

Other

Identifiers

NCT01182974

1662CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.)