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

NCT ID: NCT03438214

Last Updated: 2018-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-28

Study Completion Date

2022-12-01

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).

Conditions

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Gram-Positive Bacterial Infections Nephrotoxicity Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vancomycin continuous infusion

Continuous infusion of vancomycin

Group Type ACTIVE_COMPARATOR

Vancomycin Continuous infusion

Intervention Type 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

Vancomycin intermittent infusion

Intermittent infusion of vancomycin

Group Type ACTIVE_COMPARATOR

Vancomycin Intermittent infusion

Intervention Type 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.

Interventions

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Vancomycin Continuous infusion

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

Intervention Type DRUG

Vancomycin Intermittent infusion

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.

Intervention Type DRUG

Other Intervention Names

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Continuous infusion Intermittent infusion

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Juliano P Almeida, MD, PhD

Research associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juliano P Almeida, Professor

Role: PRINCIPAL_INVESTIGATOR

University os São Paulo

Estela M de Oliveira, PhD student

Role: PRINCIPAL_INVESTIGATOR

University os São Paulo

Locations

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Faculty of Medicine University os São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Juliano P Almeida, professor

Role: CONTACT

(5511)98149-2592

Estela M de Oliveira, PhD student

Role: CONTACT

(5516)98237-7000

Facility Contacts

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Estela M de Oliveira, investigator

Role: primary

11 98237 7000 ext. +55

Juliano P Almeida, professor

Role: backup

11 98149 2592 ext. +55

Other Identifiers

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81226617.8.1001.0065

Identifier Type: -

Identifier Source: org_study_id

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