Effect of Intermittent Infusion Versus Continuous Infusion of Vancomycin on Kidney Failure in Critically Ill Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Effect of Intermittent Infusion Versus Continuous Infusion of Vancomycin on Kidney Failure in Critically Ill Patients: Randomized and Controlled Multicenter Clinical Trial.

Conditions
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Gram-Positive Bacterial Infections, Nephrotoxicity, Sepsis

Intervention / Treatment
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* Drug: Vancomycin Continuous infusion
* Drug: Vancomycin Intermittent infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vancomycin continuous infusion<br>Continuous infusion of vancomycin | Drug: Vancomycin Continuous infusion<br>* 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<br>* Other names: Continuous infusion;|
| Active Comparator: Vancomycin intermittent infusion<br>Intermittent infusion of vancomycin | Drug: Vancomycin Intermittent infusion<br>* 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.<br>* Other names: Intermittent infusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute renal failure | Acute renal failure stage 1 according criteria AKIN (Acute Kidney Injury Network). | 30 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vancomycin infusion, critical ill patients, MRSA