NCT01182974

Brief 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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 2, 2011

Status Verified

March 1, 2011

Enrollment Period

1 year

First QC Date

August 16, 2010

Last Update Submit

March 1, 2011

Conditions

FeverSepsis

Keywords

fever in severe sepsis

Outcome Measures

Primary Outcomes (1)

  • paracetamol induced liver toxicity

    defined as ALT and/or AST \> 1000 or reduction in glutathione below 50% of base line

    every six months

Study Arms (2)

paracetamol treatment

ACTIVE COMPARATOR
Drug: paracetamol

control- dypirone treatment

ACTIVE COMPARATOR
Drug: dypirone

Interventions

paracetamolDRUG

1 gr of paracetamol PO/PZ/PR

Also known as: acetaminophen, acamol
paracetamol treatment
dypironeDRUG

1 gr PO/PZ/PR/IM

Also known as: optalgin
control- dypirone treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • acute / chronic liver disease
  • acute CNS disorder
  • current isoniazid treatment
  • alcoholism
  • active malignancy
  • pregnancy
  • TPN or PPN

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barzilai medical center

Ashkelon, 78278, Israel

Location

MeSH Terms

Conditions

FeverSepsis

Interventions

AcetaminophenDipyrone

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic Processes

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAminopyrinePyrazolonesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Albert Grinshpun

    Barziali medical center, Ashkelon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2010

First Posted

August 17, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

March 2, 2011

Record last verified: 2011-03

Locations

IL(1)