Adjustment of vancomycin dosage in critically ill patients.
Phase 1
- Conditions
- sepsis.Sepsis due to Staphylococcus aureus
- Registration Number
- IRCT201209291497N2
- Lead Sponsor
- Vice chancellor for research, Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
Age over 18 years, Glomerular Filtration Rate (GFR) > 60 ml/min, evidence of sepsis, survival prognosis> 72 hours, the lack of sensitivity to the drug, drug administration in past 72 hours.
Exclusion criteria: Patient death within 72 hours of the beginning of the study, acute renal failure during the study (according to the criteria of RIFLE), adverse drug reaction, change of treatment during the first 72 hours of treatment, discontinuation of drug during the first 72 hours of treatment, the loss of the samples of the first 48 hours, no individualization during the initial 48 hours of treatment.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative dose. Timepoint: First 72 hours of treatment. Method of measurement: sum of the used dose based on patient chart.;Maximum concentration of drug in steady state. Timepoint: After at least 3 half- life, or changing the dose. Method of measurement: ELISA KIT.;Minimum concentration of drug in steady state. Timepoint: After at least 3 half- life, or changing the dose. Method of measurement: ELISA KIT.;Mean of the intervention for dose adjustment. Timepoint: Number of dose adjustment based on pharmacokinetic data. Method of measurement: Evaluation of recorded intervention on patient's chart.
- Secondary Outcome Measures
Name Time Method Positive Expiratory End Pressure(PEEP). Timepoint: Each time patient received vancomycin. Method of measurement: Patient chart.;Tidal volume. Timepoint: Each time patient received vancomycin. Method of measurement: Patient chart.;Serum creatinin. Timepoint: Each time patient received vancomycin. Method of measurement: Patient chart.;Mean Arterial Pressure. Timepoint: Each time patient received vancomycin. Method of measurement: Patient chart.;Urine Output. Timepoint: Each time patient received vancomycin. Method of measurement: Patient chart.