Pharmacokinetic of Ceftriaxone in Septic ICU Patients

NCT00449800 | Unknown Phase 4

• 1 other identifier: APTRM 2006-02
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Severe Sepsis; Septic Shock

Keywords

Sepsis; Ceftriaxone; Pharmacokinetic; Intensive care unit

Outcome Measures

Primary Outcomes (3)

• serum drug concentration

• pharmacokinetics parameter (plasmatic half-life, clearance, ...)

• ratio of serum drug concentration on MCI

Interventions

ceftriaxone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Association Pour La Promotion A Tours De La Reanimation Medicale: lead

Study Sites (1)

Cenrte Hospitalier Régional Universitaire

Tours, 37044, France

RECRUITING

Related Publications (1)

• Garot D, Respaud R, Lanotte P, Simon N, Mercier E, Ehrmann S, Perrotin D, Dequin PF, Le Guellec C. Population pharmacokinetics of ceftriaxone in critically ill septic patients: a reappraisal. Br J Clin Pharmacol. 2011 Nov;72(5):758-67. doi: 10.1111/j.1365-2125.2011.04005.x.

  PMID: 21545483 DERIVED

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Ceftriaxone

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• DENIS GAROT, MD

  CHRU TOURS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DENIS GAROT, MD

CONTACT

+33 2 47 47 38 55; garot@med.univ-tours.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 14, 2007
• First Posted: March 21, 2007
• Study Start: July 1, 2006
• Study Completion: March 1, 2007
• Last Updated: March 21, 2007

Record last verified: 2007-03

Locations

FR (1)