A study to compare the blood levels achieved by meropenem after a 30 minute infusion versus a three hour infusion in patients with normal and poor kidney function in IC
- Conditions
- Health Condition 1: null- ICU patients with normal and poor renal functionHealth Condition 2: A415- Sepsis due to other Gram-negativeorganisms
- Registration Number
- CTRI/2012/11/003095
- Lead Sponsor
- Christian Medical College Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
1.Suspected infection warranting meropenem therapy. The clinical indications for administration of meropenem include skin and soft tissue infections, pneumonia, intraâ??abdominal sepsis, urinary tract infection, blood stream infection, meningitis and empirical therapy for sepsis without proven source.
2.Age above 18 years
3.Patients who will be continued on Meropenem after culture results (by Day2)
4.ICU stay and IV Meropenem therapy expected to last for at least 3 days.
5.Patients whose GFR calculated by CockroftGault formula is within the limits as specified in this study (See below â?? Methodology).
6.Patients with an intra-arterial access for blood specimen collection.
1.Documented or presumed hypersensitivity to penicillin or any carbapenems.
2.Patients with previous history of seizures.
3.Patients on dialysis.
4.Patients with moderate to severe hepatic impairment.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of patients achieving a meropenem concentration greater than the MIC for over 40% of the inter-dosing interval.Timepoint: Day 3 of study
- Secondary Outcome Measures
Name Time Method a)The percentage of patients achieving therapeutic concentrations (in relation to the MIC) for 60% and 100% of the time will be determined- with different regimens in all groups. <br/ ><br>b)Interpatientvariability inarea under the curve will be calculated in all the groups <br/ ><br>c)Establishpharmacokinetic parameters for the two dosing regimens in patients with both normal and poor renal function <br/ ><br>d)Establish the current MIC of meropenem. <br/ ><br>Timepoint: From starting recruting the patient to the end of the study