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

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

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.

Study Overview

• Status: Unknown
• Conditions: Sepsis; Gram-Positive Bacterial Infections; Nephrotoxicity
• Intervention / Treatment: Drug: Vancomycin Continuous infusion; Drug: Vancomycin Intermittent infusion

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 Type: Interventional
• Enrollment (Anticipated): 222
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 01246-903
      • Faculty of Medicine University os São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute renal failure	Acute renal failure stage 1 according criteria AKIN (Acute Kidney Injury Network).	30 days after randomization

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Anticipated): April 28, 2018
• Primary Completion (Anticipated): February 28, 2020
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 15, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: MRSA; Vancomycin infusion; critical ill patients
• Additional Relevant MeSH Terms: Infections; Kidney Diseases; Urologic Diseases; Bacterial Infections and Mycoses; Renal Insufficiency; Bacterial Infections; Gram-Positive Bacterial Infections; Anti-Infective Agents; Anti-Bacterial Agents; Vancomycin
• Other Study ID Numbers: 81226617.8.1001.0065

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes