Paracetamol Toxicity in Septic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fever Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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paracetamol treatment

Group Type ACTIVE_COMPARATOR

paracetamol

Intervention Type DRUG

1 gr of paracetamol PO/PZ/PR

control- dypirone treatment

Group Type ACTIVE_COMPARATOR

dypirone

Intervention Type DRUG

1 gr PO/PZ/PR/IM

Interventions

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paracetamol

1 gr of paracetamol PO/PZ/PR

Intervention Type DRUG

dypirone

1 gr PO/PZ/PR/IM

Intervention Type DRUG

Other Intervention Names

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acetaminophen, acamol optalgin

Eligibility Criteria

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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.)