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

Sponsor

University of Sao Paulo (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT03438214

Collaborator

(none)

222

Enrollment

Location

Arms

55.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gram-Positive Bacterial Infections Nephrotoxicity Sepsis	Drug: Vancomycin Continuous infusion Drug: Vancomycin Intermittent infusion	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

222 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 28, 2018

Anticipated Primary Completion Date :

Feb 28, 2020

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vancomycin continuous infusion Continuous infusion of vancomycin	Drug: 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 Other Names: Continuous infusion
Active Comparator: Vancomycin intermittent infusion Intermittent infusion of vancomycin	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. Other Names: Intermittent infusion

Arm

Intervention/Treatment

Active Comparator: Vancomycin continuous infusion

Continuous infusion of vancomycin

Drug: 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

Other Names:

Continuous infusion

Active Comparator: Vancomycin intermittent infusion

Intermittent infusion of vancomycin

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.

Other Names:

Intermittent infusion

Outcome Measures

Primary Outcome Measures

Acute renal failure [30 days after randomization]
Acute renal failure stage 1 according criteria AKIN (Acute Kidney Injury Network).

Secondary Outcome Measures

Acute renal failure [30 days after randomization]
Acute renal failure stages 2 or 3 according criteria AKIN (Acute Kidney Injury Network).
Hypersensibility reactions with vancomycin [30 days after randomization]
Skin rash, bronchospasm or anaphylaxis / anaphylactic shock.
Length of ICU stay [30 days after randomization]
Therapeutic efficacy with less length of ICU stay
Time of treatment with the antimicrobial [30 days after randomization]
Therapeutic efficacy with less time of treatment with the antimicrobial
Length of hospitalization [30 days after randomization]
Therapeutic efficacy with less length of hospitalization
Mortality rate [30 days after randomization]
Therapeutic efficacy with less mortality rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine University os São Paulo	São Paulo	SP	Brazil	01246-903

Sponsors and Collaborators

University of Sao Paulo

Investigators

Principal Investigator: Juliano P Almeida, Professor, University os São Paulo
Principal Investigator: Estela M de Oliveira, PhD student, University os São Paulo