Pharmacokinetic of Ceftriaxone in Septic ICU Patients (PORTHOS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Association Pour La Promotion A Tours De La Reanimation Medicale.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Association Pour La Promotion A Tours De La Reanimation Medicale
ClinicalTrials.gov Identifier:
NCT00449800
First received: March 14, 2007
Last updated: March 20, 2007
Last verified: March 2007
  Purpose

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 Intervention Phase
Sepsis
Severe Sepsis
Septic Shock
Drug: ceftriaxone
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics Variability of Ceftriaxone in Septic ICU Patients

Resource links provided by NLM:


Further study details as provided by Association Pour La Promotion A Tours De La Reanimation Medicale:

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

Estimated Enrollment: 70
Study Start Date: July 2006
Estimated Study Completion Date: March 2007
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449800

Contacts
Contact: DENIS GAROT, MD +33 2 47 47 38 55 garot@med.univ-tours.fr

Locations
France
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
Investigators
Principal Investigator: DENIS GAROT, MD chru tours
  More Information

No publications provided by Association Pour La Promotion A Tours De La Reanimation Medicale

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00449800     History of Changes
Other Study ID Numbers: APTRM 2006-02
Study First Received: March 14, 2007
Last Updated: March 20, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Association Pour La Promotion A Tours De La Reanimation Medicale:
Sepsis
Ceftriaxone
Pharmacokinetic
Intensive care unit

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Ceftriaxone
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014