Effect of Intermittent Infusion Versus Continuous Infusion of Vancomycin on Kidney Failure in Critically Ill Patients: Randomized and Controlled Multicenter Clinical Trial.
Overview
- Phase
- Phase 4
- Intervention
- Vancomycin Continuous infusion
- Conditions
- Gram-Positive Bacterial Infections
- Sponsor
- University of Sao Paulo
- Enrollment
- 222
- Locations
- 1
- Primary Endpoint
- Acute renal failure
- Last Updated
- 8 years ago
Overview
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).
Investigators
Juliano P Almeida, MD, PhD
Research associate
University of Sao Paulo
Eligibility Criteria
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
Arms & Interventions
Vancomycin continuous infusion
Continuous infusion of vancomycin
Intervention: Vancomycin Continuous infusion
Vancomycin intermittent infusion
Intermittent infusion of vancomycin
Intervention: Vancomycin Intermittent infusion
Outcomes
Primary Outcomes
Acute renal failure
Time Frame: 30 days after randomization
Acute renal failure stage 1 according criteria AKIN (Acute Kidney Injury Network).
Secondary Outcomes
- Acute renal failure(30 days after randomization)
- Length of ICU stay(30 days after randomization)
- Length of hospitalization(30 days after randomization)
- Time of treatment with the antimicrobial(30 days after randomization)
- Hypersensibility reactions with vancomycin(30 days after randomization)
- Mortality rate(30 days after randomization)