Effect of Intermittent Infusion Versus Continuous Infusion of Vancomycin on Kidney Failure in Critically Ill Patients
ETERNITY
1 other identifier
interventional
222
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2018
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2018
CompletedFirst Posted
Study publicly available on registry
February 19, 2018
CompletedStudy Start
First participant enrolled
April 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedApril 5, 2018
April 1, 2018
1.8 years
February 5, 2018
April 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute renal failure
Acute renal failure stage 1 according criteria AKIN (Acute Kidney Injury Network).
30 days after randomization
Secondary Outcomes (6)
Acute renal failure
30 days after randomization
Hypersensibility reactions with vancomycin
30 days after randomization
Length of ICU stay
30 days after randomization
Time of treatment with the antimicrobial
30 days after randomization
Length of hospitalization
30 days after randomization
- +1 more secondary outcomes
Study Arms (2)
Vancomycin continuous infusion
ACTIVE COMPARATORContinuous infusion of vancomycin
Vancomycin intermittent infusion
ACTIVE COMPARATORIntermittent infusion of vancomycin
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- Critically ill patients
- Treatment with vancomycin
- Preserved renal function.
You may not qualify if:
- Cystic fibrosis
- Chronic renal failure
- Acute renal failure
- Having received vancomycin in the last 24 hours
- Vancomycin hypersensibility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine University os São Paulo
São Paulo, São Paulo, 01246-903, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juliano P Almeida, Professor
University os São Paulo
- PRINCIPAL INVESTIGATOR
Estela M de Oliveira, PhD student
University os São Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research associate
Study Record Dates
First Submitted
February 5, 2018
First Posted
February 19, 2018
Study Start
April 28, 2018
Primary Completion
February 28, 2020
Study Completion
December 1, 2022
Last Updated
April 5, 2018
Record last verified: 2018-04