sepsis. Sepsis due to Staphylococcus aureus
Conditions
Interventions
Intervention 1: In the first phase, due to the uncertainty constant serum concentrations of fixed dose regimen -in patients who have indications for treatment with vancomycin- serum concentrations of
Treatment - Drugs
In the first phase, due to the uncertainty constant serum concentrations of fixed dose regimen -in patients who have indications for treatment with vancomycin- serum concentrations of vancomycin for 4
Phase 2:
At this stage, patients are divided randomly (block randomization based on block size 4) into two groups. The first group of patients will be treated using a fixed-dose protocol of 25mg/kg/s
Patients who have the inclusion criteria will be enrolled to the study and received vancomycin (Jaber Ebne Hayyan Pharmaceutical Co., Tehran, Iran) through Intravenous infusion (at least 1 hour), with
Sponsors
Vice chancellor for research, Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Farhad Najmedin
Clinical Pharmacy Department, School of Pharmacy, Tehran University of Medical Sciences
Outcome results
None listed