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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vancomycin continuous infusion | Active Comparator | Continuous infusion of vancomycin |
|
| Vancomycin intermittent infusion | Active Comparator | Intermittent infusion of vancomycin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin Continuous infusion | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acute renal failure | Acute renal failure stage 1 according criteria AKIN (Acute Kidney Injury Network). | 30 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Acute renal failure | Acute renal failure stages 2 or 3 according criteria AKIN (Acute Kidney Injury Network). | 30 days after randomization |
| Hypersensibility reactions with vancomycin | Skin rash, bronchospasm or anaphylaxis / anaphylactic shock. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juliano P Almeida, professor | Contact | (5511)98149-2592 | doctorjuliano@yahoo.com.br | |
| Estela M de Oliveira, PhD student | Contact | (5516)98237-7000 | estela.oliveira27@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Juliano P Almeida, Professor | University os São Paulo | Principal Investigator |
| Estela M de Oliveira, PhD student | University os São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine University os São Paulo | São Paulo | São Paulo | 01246-903 | Brazil |
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| Vancomycin Intermittent infusion | Drug | 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. |
|
|
| 30 days after randomization |
| Length of ICU stay | Therapeutic efficacy with less length of ICU stay | 30 days after randomization |
| Time of treatment with the antimicrobial | Therapeutic efficacy with less time of treatment with the antimicrobial | 30 days after randomization |
| Length of hospitalization | Therapeutic efficacy with less length of hospitalization | 30 days after randomization |
| Mortality rate | Therapeutic efficacy with less mortality rate | 30 days after randomization |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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