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

University of Sao Paulo

Status and phase: Unknown; Phase 4

Conditions: Nephrotoxicity; Gram-Positive Bacterial Infections; Sepsis

Treatments: Drug: Vancomycin Continuous infusion; Drug: Vancomycin Intermittent infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03438214

81226617.8.1001.0065

Details and patient eligibility

About

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.

Full 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).

Enrollment: 222 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 2 patient groups

Vancomycin continuous infusion

Active Comparator group

Description:

Continuous infusion of vancomycin

Treatment:

Drug: Vancomycin Continuous infusion

Vancomycin intermittent infusion

Active Comparator group

Description:

Intermittent infusion of vancomycin

Treatment:

Drug: Vancomycin Intermittent infusion