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Pharmacokinetic of Ceftriaxone in Septic ICU Patients (PORTHOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00449800
Recruitment Status : Unknown
Verified March 2007 by Association Pour La Promotion A Tours De La Reanimation Medicale.
Recruitment status was:  Recruiting
First Posted : March 21, 2007
Last Update Posted : March 21, 2007
Information provided by:
Association Pour La Promotion A Tours De La Reanimation Medicale

Brief Summary:

Ceftriaxone pharmacokinetics variability in intensive care unit septic patients

In intensive care units, drug dosage is often based on study made on healthy volunteers or on less severe patients.

However, pharmacokinetic alterations have been described for some drugs used in intensive care units.

These alterations, consequences of alteration of volume of distribution, of protein concentrations, of impaired hepatic and renal functions can result in accumulation with toxicity or " under dosage " with inefficacity.

Ceftriaxone is an antibiotic often prescribed in intensive care unit. However, despite this large utilisation, very few data is available on the pharmacokinetic in intensive care unit, and optimal dosage is not known.

Our objective is to develop a population pharmacokinetics model of ceftriaxone in intensive care unit patients with sepsis, severe sepsis and septic shock and to identify the " data " explaining interindividual variability of each pharmacokinetics parameter.

Condition or disease Intervention/treatment Phase
Sepsis Severe Sepsis Septic Shock Drug: ceftriaxone Phase 4

Detailed Description:

This is a one centre population pharmacokinetics non interventional study. One group of 50 patients allows the development of the model and a second group of 20 patients will be used for the validation of the model.

Septic patients treated with ceftriaxone according to standard procedure of our ICU could be included before the second administration of the drug. In the development group, patients will underwent five determination of serum concentration of ceftriaxone during the 24 hours following the second administration. The timing of samples will be randomised in three groups. A second phase of sampling will take place during the fifth day of ceftriaxone therapy for sepsis and severe sepsis patients and after 48 hours catecholamine- free for septic shock patients.

For the validation group, ten samples will be obtained at the same periods. This study will not induce any change in the care of patients.

Samples will be centrifugated immediately after collection and conserved at - 20 °C.

Ceftriaxone will be assayed in the department of pharmacology, university of Marseille France, usig HPLC method.

Pharmacokinetic analysis will used NONlinear Mixed Effects Modelling logiciel

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Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics Variability of Ceftriaxone in Septic ICU Patients
Study Start Date : July 2006
Estimated Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Primary Outcome Measures :
  1. serum drug concentration
  2. pharmacokinetics parameter (plasmatic half-life, clearance, ...)
  3. ratio of serum drug concentration on MCI

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Eighteen-year or more
  • sepsis, severe sepsis or septic shock (according to Bone's criteria)
  • admission to intensive care unit
  • informed consent obtained
  • affiliation to medicare

Exclusion Criteria:

  • Previous haemodialysis
  • hemopathy
  • known allergy to cephalosporin
  • patients whose death is considered imminent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00449800

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Contact: DENIS GAROT, MD +33 2 47 47 38 55

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Cenrte Hospitalier Régional Universitaire Recruiting
Tours, France, 37044
Principal Investigator: DENIS GAROT, MD         
Sponsors and Collaborators
Association Pour La Promotion A Tours De La Reanimation Medicale
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Principal Investigator: DENIS GAROT, MD chru tours
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00449800    
Other Study ID Numbers: APTRM 2006-02
First Posted: March 21, 2007    Key Record Dates
Last Update Posted: March 21, 2007
Last Verified: March 2007
Keywords provided by Association Pour La Promotion A Tours De La Reanimation Medicale:
Intensive care unit
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents