Informations générales (source: ClinicalTrials.gov)
Pharmacokinetics Variability of Ceftriaxone in Septic ICU Patients (PORTHOS)
Interventional
Phase 4
Association Pour La Promotion A Tours De La Reanimation Medicale (Voir sur ClinicalTrials)
juillet 2006
mars 2007
29 juin 2024
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.
Etablissements
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
---|---|---|---|---|---|
Cenrte Hospitalier Régional Universitaire - 37044 - Tours - France | Contact (sur clinicalTrials) |
Critères
Tous
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
- 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
- Previous haemodialysis
- hemopathy
- known allergy to cephalosporin
- patients whose death is considered imminent