Paracetamol Toxicity in Septic Patients

Sepsis Clinical Trial

Official title:

Paracetamol-induced Liver Toxicity in Septic Patients

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01182974
• Other study ID #: 1662CTIL
• Status: Suspended
• Phase: Phase 3
• First received: August 16, 2010
• Last updated: March 1, 2011
• Start date: August 2010
• Est. completion date: August 2011

Study information

• Verified date: March 2011
• Source: Barzilai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 80
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Fever
• Sepsis

Intervention

Drug:
• paracetamol
1 gr of paracetamol PO/PZ/PR
• dypirone
1 gr PO/PZ/PR/IM

Locations

Country	Name	City	State
Israel	Barzilai medical center	Ashkelon

Sponsors (2)

Lead Sponsor	Collaborator
Barzilai Medical Center	Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	paracetamol induced liver toxicity	defined as ALT and/or AST > 1000 or reduction in glutathione below 50% of base line	every six months	No