Informations générales (source: ClinicalTrials.gov)

NCT00449800 Statut inconnu
Pharmacokinetics Variability of Ceftriaxone in Septic ICU Patients (PORTHOS)
Interventional
  • Toxémie
  • Sepsie
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.
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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 En recrutement 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



- Previous haemodialysis

- hemopathy

- known allergy to cephalosporin

- patients whose death is considered imminent