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Pharmacokinetic of Ceftriaxone in Septic ICU Patients

NCT00449800 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2007-03-21

No results posted yet for this study

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.

Conditions

  • Sepsis
  • Severe Sepsis
  • Septic Shock

Interventions

DRUG

ceftriaxone

Sponsors & Collaborators

  • Association Pour La Promotion A Tours De La Reanimation Medicale

    lead OTHER

Principal Investigators

  • DENIS GAROT, MD · CHRU TOURS

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Completion
2007-03-31

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00449800 on ClinicalTrials.gov