Early optimization of ceftazidine dosing regimen in critical care : FORTOPTIM_1

Conditions

sepsis

Brief summary

Percentage of subjects with a ceftazidime concentration equal to or above the target concentration threshold (35 mg/L) at both 3h and 24h after the first administration and below the toxicity threshold of 100 mg/L

Detailed description

Patient severity assessed using the SOFA (Sepsis related Organ Failure Assessment) score at D0 and D7. The SOFA score is a tool used in intensive care to assess the severity of organ failure in critical patients. The score assesses the function of six systems: respiratory, cardiovascular, hepatic, hemostatic, renal and neurological. Each system is scored from 0 to 4, meaning that the total SOFA score can vary from 0 to 24. There is no specific threshold for determining disease severity, as the S, Death up to D28, Occurrence of neurological adverse events defined as: seizure, myoclonus, encephalopathy or delirium, altered consciousness (Glasgow score), Occurrence of an overdose defined as a concentration greater than 100 mg/L, Renal function assessed using the following estimators: creatinemia cystatin CKD-EPI, creatinuria/creatininemia ratio (U×V/P) and eGFR creat-cystatin, Time to reach PK/PD targets (in hours post treatment introduction)

Related papers

No related papers found yet.

Interventions

DRUGCEFTAZIDIME

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of subjects with a ceftazidime concentration equal to or above the target concentration threshold (35 mg/L) at both 3h and 24h after the first administration and below the toxicity threshold of 100 mg/L	—

Secondary

Measure	Time frame
Patient severity assessed using the SOFA (Sepsis related Organ Failure Assessment) score at D0 and D7. The SOFA score is a tool used in intensive care to assess the severity of organ failure in critical patients. The score assesses the function of six systems: respiratory, cardiovascular, hepatic, hemostatic, renal and neurological. Each system is scored from 0 to 4, meaning that the total SOFA score can vary from 0 to 24. There is no specific threshold for determining disease severity, as the S, Death up to D28, Occurrence of neurological adverse events defined as: seizure, myoclonus, encephalopathy or delirium, altered consciousness (Glasgow score), Occurrence of an overdose defined as a concentration greater than 100 mg/L, Renal function assessed using the following estimators: creatinemia cystatin CKD-EPI, creatinuria/creatininemia ratio (U×V/P) and eGFR creat-cystatin, Time to reach PK/PD targets (in hours post treatment introduction)	—

Measure

Time frame

Patient severity assessed using the SOFA (Sepsis related Organ Failure Assessment) score at D0 and D7. The SOFA score is a tool used in intensive care to assess the severity of organ failure in critical patients. The score assesses the function of six systems: respiratory, cardiovascular, hepatic, hemostatic, renal and neurological. Each system is scored from 0 to 4, meaning that the total SOFA score can vary from 0 to 24. There is no specific threshold for determining disease severity, as the S, Death up to D28, Occurrence of neurological adverse events defined as: seizure, myoclonus, encephalopathy or delirium, altered consciousness (Glasgow score), Occurrence of an overdose defined as a concentration greater than 100 mg/L, Renal function assessed using the following estimators: creatinemia cystatin CKD-EPI, creatinuria/creatininemia ratio (U×V/P) and eGFR creat-cystatin, Time to reach PK/PD targets (in hours post treatment introduction)

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Countries

France

Outcome results

None listed