FeverPhase 3NCT01182974
Paracetamol Toxicity in Septic Patients
A Phase 3 study testing paracetamol and dypirone in people with Fever and Sepsis, run by Barzilai Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- paracetamol and dypirone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to Aug 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- one of the following:
- hypotension
- disturbed end-organ perfusion (confusion, oliguria, lactic acidosis etc.)
Who cannot join
- acute / chronic liver disease
- acute CNS disorder
- current isoniazid treatment
- alcoholism
- active malignancy
- pregnancy
- TPN or PPN
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Paracetamol-induced Liver Toxicity in Septic Patients
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.
Read the 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.
- Being tested
- paracetamol, dypirone
- Keywords
- fever in severe sepsis
- Medical subject headings
- Fever, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamolDrug
Also called acetaminophen, acamol
1 gr of paracetamol PO/PZ/PR
dypironeDrug
Also called optalgin
1 gr PO/PZ/PR/IM
| Study group | Role | What they receive |
|---|---|---|
| paracetamol treatment | Active comparator | Not described Receives: Drug: paracetamol |
| control- dypirone treatment | Active comparator | Not described Receives: Drug: dypirone |
What is being measured
The primary outcome is the main question the study is designed to answer.
paracetamol induced liver toxicity
defined as ALT and/or AST > 1000 or reduction in glutathione below 50% of base line
Measured: every six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Why it stopped: Difficulty in patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barzilai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hadassah Medical Organization
- Investigators
- Albert Grinshpun, Principal investigator, Barziali medical center, Ashkelon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182974
- Sponsor's protocol ID
- 1662CTIL
- Status last verified
- Mar 2011
- First submitted
- 16 Aug 2010
- Last updated
- 2 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracetamol-induced Liver Toxicity in Septic Patients
- ClinicalTrials.gov ID
- NCT01182974
- Acronym / sponsor ID
- 1662CTIL
- Keywords
- fever in severe sepsis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Difficulty in patient enrollment
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Barzilai Medical CenterUniversity, hospital or other
- Collaborators
- Hadassah Medical Organization
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paracetamol treatment | Active comparator | Drug: paracetamol |
| control- dypirone treatment | Active comparator | Drug: dypirone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- age>18y
- hospitalized to int. med. dept. or ICU
- body temp>38 and one or more from the following:
- one of the following:
Key exclusion criteria (7 listed)
- acute / chronic liver disease
- acute CNS disorder
- current isoniazid treatment
- alcoholism
- active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paracetamolAlso: acetaminophen, acamol1 gr of paracetamol PO/PZ/PR | Drug | paracetamol treatment |
| dypironeAlso: optalgin1 gr PO/PZ/PR/IM | Drug | control- dypirone treatment |
Primary outcome
paracetamol induced liver toxicity
Time frame: every six months
defined as ALT and/or AST > 1000 or reduction in glutathione below 50% of base line
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Grinshpun principal investigator
Barziali medical center, Ashkelon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing paracetamol and dypirone in people with Fever and Sepsis, run by Barzilai Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 2 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
paracetamol induced liver toxicity (time frame: every six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2011.