Gram-Positive Bacterial Infections, Nephrotoxicity, Sepsis
Conditions
Keywords
Vancomycin infusion, critical ill patients, MRSA
Brief summary
This is a randomized, controlled multicenter clinical trial. The purpose of this study is to compare the continuous infusion of vancomycin with intermittent infusion regarding the effectiveness to reach the target serum level and the relationship between infusion type and nephrotoxicity in critically ill patients.
Detailed description
The vancomycin is a glycopeptide antimicrobial which has been used for 50 years against gram-positive microorganisms and remains effective against multiresistant bacteria as the methicillin resistant Staphylococcus aureus (MRSA), the main microorganism causing nosocomial infections. Around the world, the continuous infusion of vancomycin has been studied and associated with less rate of nephrotoxicity. This is a randomized, controlled multicenter clinical trial that will compare continuous infusion with the intermittent vancomycin infusion, the relationship between infusion type with rate of nephrotoxicity and the time to target therapeutic serum in critically ill patients at the intensive care units of the Cancer Institute of the State of Sao Paulo (ICESP) and the Heart Institute (Incor).
Interventions
Will be administered a loading dose of 25mg/kg followed of 2g infused in 24h. Serum levels will be measured after the end of the loading dose (peak) and after 24 hours (steady state). The doses will be adjusted according to serum levels (between 15 and 20 mg / L) and area under curve (AUC) /MIC≥400mg.h/L
Will be administered a loading dose of 25mg/kg followed of 1g every 12h. Serum levels will be measured after the end of the loading dose (peak) and one hour before the next dose (trough). The doses will be adjusted according to serum levels (between 15 and 20 mg / L) and AUC/MIC≥400mg.h/L.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Critically ill patients * Treatment with vancomycin * Preserved renal function.
Exclusion criteria
* Cystic fibrosis * Chronic renal failure * Acute renal failure * Having received vancomycin in the last 24 hours * Vancomycin hypersensibility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute renal failure | 30 days after randomization | Acute renal failure stage 1 according criteria AKIN (Acute Kidney Injury Network). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality rate | 30 days after randomization | Therapeutic efficacy with less mortality rate |
| Acute renal failure | 30 days after randomization | Acute renal failure stages 2 or 3 according criteria AKIN (Acute Kidney Injury Network). |
| Length of hospitalization | 30 days after randomization | Therapeutic efficacy with less length of hospitalization |
| Length of ICU stay | 30 days after randomization | Therapeutic efficacy with less length of ICU stay |
| Time of treatment with the antimicrobial | 30 days after randomization | Therapeutic efficacy with less time of treatment with the antimicrobial |
| Hypersensibility reactions with vancomycin | 30 days after randomization | Skin rash, bronchospasm or anaphylaxis / anaphylactic shock. |
Countries
Brazil
Contacts
Primary ContactJuliano P Almeida, professor
Backup ContactEstela M de Oliveira, PhD student
Outcome results
None listed