Health Condition 1: null- critically ill patients in ICU
Conditions
Interventions
Intervention1: Meropenem: This is an observational study. Meropenem is a broad spectrum antibiotic used for empirical treatment in patients with severe sepsis. This is a pharmacokinetic study to deter
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria • Adult critically ill patients • Age 18 yr to 70 yrs • Known or suspected sepsis. • Baseline plasma creatinine concentration within upper limit of normal • Meropenem (MEROMER®) therapy initiated in ICU and expected to be continued for at least 3 days
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T1. Peak plasma meropenem level 1. fT (Time duration for which plasma concentration is above MIC) 2. Proportion of patients with fT 40% of dosing interval. 3. Pharmacokinetics parameters including AUC, Cmax, Tmax, Volume of Distribution (Vd), Half-life (T1/2), Clearance (Cl) and elimination rate constant (Kel) 4. Time to MIC after first dose Timepoint: time zero, 5 min, 15 min, 30 min, and 1, 1.5, 2, 3, 4, 5, 6 and 8 h after the first dose of meropenum | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetics parameters including AUC, Cmax, Tmax, Volume of Distribution (Vd), Half-life (T1/2), Clearance (Cl) and elimination rate constant (Kel) 2. Time to MIC after first dose Timepoint: time zero, 5 min, 15 min, 30 min, and 1, 1.5, 2, 3, 4, 5, 6 and 8 h after the first dose of meropenum | — |
Countries
India
Contacts
Public ContactDr J V Divatia
Department of Anesthesia, Critical Care and Pain, Tata Memorial Centre
Outcome results
None listed