Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449800
Status:
UNKNOWN
Last Update Posted:
2007-03-21
First Post:
2007-03-14
Brief Title:
Pharmacokinetic of Ceftriaxone in Septic ICU Patients
Sponsor:
Association Pour La Promotion A Tours De La Reanimation Medicale
Organization:
Association Pour La Promotion A Tours De La Reanimation Medicale
Study Overview
Official Title:
Pharmacokinetics Variability of Ceftriaxone in Septic ICU Patients
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PORTHOS
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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None