Paracetamol Toxicity in Septic Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fever Sepsis |
Drug: paracetamol Drug: dypirone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Paracetamol-induced Liver Toxicity in Septic Patients |
- 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
| Estimated Enrollment: | 80 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: paracetamol treatment |
Drug: paracetamol
1 gr of paracetamol PO/PZ/PR
Other Name: acetaminophen, acamol
|
| Active Comparator: control- dypirone treatment |
Drug: dypirone
1 gr PO/PZ/PR/IM
Other Name: optalgin
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age>18y
- hospitalized to int. med. dept. or ICU
body temp>38 and one or more from the following:
- pulse>90 bpm
- resp. rate>20/min or PaCO2<32 mmHg
- WBC>12000 or <4000
one of the following:
- hypotension
- 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
Contacts and Locations| Israel | |
| Barzilai medical center | |
| Ashkelon, Israel, 78278 | |
| Principal Investigator: | Albert Grinshpun | Barziali medical center, Ashkelon |
More Information
No publications provided
| Responsible Party: | Albert Grinshpun, Barzilai medical center |
| ClinicalTrials.gov Identifier: | NCT01182974 History of Changes |
| Other Study ID Numbers: | 1662CTIL |
| Study First Received: | August 16, 2010 |
| Last Updated: | March 1, 2011 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Barzilai Medical Center:
|
fever in severe sepsis |
Additional relevant MeSH terms:
|
Fever Sepsis Body Temperature Changes Signs and Symptoms Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Acetaminophen |
Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013