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

Phase 4

• Conditions: Gram-Positive Bacterial Infections; Nephrotoxicity; Sepsis
• Interventions: Drug: Vancomycin Continuous infusion; Drug: Vancomycin Intermittent infusion

• Registration Number: NCT03438214
• Lead Sponsor: University of Sao Paulo

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).

Study Timeline

• Study First Submitted: 2018-02-05
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-19
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-05
• Study Start: 2018-04-28
• Primary Completion: 2020-02-28
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

• Critically ill patients
• Treatment with vancomycin
• Preserved renal function.

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Exclusion Criteria

• Cystic fibrosis
• Chronic renal failure
• Acute renal failure
• Having received vancomycin in the last 24 hours
• Vancomycin hypersensibility

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vancomycin continuous infusion	Vancomycin Continuous infusion	Continuous infusion of vancomycin
Vancomycin intermittent infusion	Vancomycin Intermittent infusion	Intermittent infusion of vancomycin

Primary Outcome Measures

Name	Time	Method
Acute renal failure	30 days after randomization	Acute renal failure stage 1 according criteria AKIN (Acute Kidney Injury Network).

Secondary Outcome Measures

Name	Time	Method
Acute renal failure	30 days after randomization	Acute renal failure stages 2 or 3 according criteria AKIN (Acute Kidney Injury Network).
Length of ICU stay	30 days after randomization	Therapeutic efficacy with less length of ICU stay
Length of hospitalization	30 days after randomization	Therapeutic efficacy with less length of hospitalization
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.
Mortality rate	30 days after randomization	Therapeutic efficacy with less mortality rate

Trial Locations

Locations (1)

Faculty of Medicine University os São Paulo; 🇧🇷 São Paulo, SP, Brazil