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

Primary Purpose

Gram-Positive Bacterial Infections, Nephrotoxicity, Sepsis

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Vancomycin Continuous infusion
Vancomycin Intermittent infusion
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gram-Positive Bacterial Infections focused on measuring Vancomycin infusion, critical ill patients, MRSA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Faculty of Medicine University os São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Vancomycin continuous infusion

Vancomycin intermittent infusion

Arm Description

Continuous infusion of vancomycin

Intermittent infusion of vancomycin

Outcomes

Primary Outcome Measures

Acute renal failure
Acute renal failure stage 1 according criteria AKIN (Acute Kidney Injury Network).

Secondary Outcome Measures

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

Full Information

First Posted
February 5, 2018
Last Updated
April 3, 2018
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03438214
Brief Title
Effect of Intermittent Infusion Versus Continuous Infusion of Vancomycin on Kidney Failure in Critically Ill Patients
Acronym
ETERNITY
Official Title
Effect of Intermittent Infusion Versus Continuous Infusion of Vancomycin on Kidney Failure in Critically Ill Patients: Randomized and Controlled Multicenter Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 28, 2018 (Anticipated)
Primary Completion Date
February 28, 2020 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gram-Positive Bacterial Infections, Nephrotoxicity, Sepsis
Keywords
Vancomycin infusion, critical ill patients, MRSA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
222 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vancomycin continuous infusion
Arm Type
Active Comparator
Arm Description
Continuous infusion of vancomycin
Arm Title
Vancomycin intermittent infusion
Arm Type
Active Comparator
Arm Description
Intermittent infusion of vancomycin
Intervention Type
Drug
Intervention Name(s)
Vancomycin Continuous infusion
Other Intervention Name(s)
Continuous infusion
Intervention Description
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
Intervention Name(s)
Vancomycin Intermittent infusion
Other Intervention Name(s)
Intermittent infusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acute renal failure
Description
Acute renal failure stage 1 according criteria AKIN (Acute Kidney Injury Network).
Time Frame
30 days after randomization
Secondary Outcome Measure Information:
Title
Acute renal failure
Description
Acute renal failure stages 2 or 3 according criteria AKIN (Acute Kidney Injury Network).
Time Frame
30 days after randomization
Title
Hypersensibility reactions with vancomycin
Description
Skin rash, bronchospasm or anaphylaxis / anaphylactic shock.
Time Frame
30 days after randomization
Title
Length of ICU stay
Description
Therapeutic efficacy with less length of ICU stay
Time Frame
30 days after randomization
Title
Time of treatment with the antimicrobial
Description
Therapeutic efficacy with less time of treatment with the antimicrobial
Time Frame
30 days after randomization
Title
Length of hospitalization
Description
Therapeutic efficacy with less length of hospitalization
Time Frame
30 days after randomization
Title
Mortality rate
Description
Therapeutic efficacy with less mortality rate
Time Frame
30 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliano P Almeida, professor
Phone
(5511)98149-2592
Email
doctorjuliano@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Estela M de Oliveira, PhD student
Phone
(5516)98237-7000
Email
estela.oliveira27@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliano P Almeida, Professor
Organizational Affiliation
University os São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Estela M de Oliveira, PhD student
Organizational Affiliation
University os São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine University os São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
01246-903
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estela M de Oliveira, investigator
Phone
11 98237 7000
Ext
+55
Email
estela.oliveira27@hotmail.com
First Name & Middle Initial & Last Name & Degree
Juliano P Almeida, professor
Phone
11 98149 2592
Ext
+55
Email
doctorjuliano@yahoo.com.br

12. IPD Sharing Statement

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

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