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

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ClinicalTrials.gov Identifier: NCT03438214
Recruitment Status : Not yet recruiting
First Posted : February 19, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Juliano P Almeida, MD, PhD, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE February 5, 2018
First Posted Date  ICMJE February 19, 2018
Last Update Posted Date April 5, 2018
Estimated Study Start Date  ICMJE April 28, 2018
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
Acute renal failure [ Time Frame: 30 days after randomization ]
Acute renal failure stage 1 according criteria AKIN (Acute Kidney Injury Network).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03438214 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2018)
  • Acute renal failure [ Time Frame: 30 days after randomization ]
    Acute renal failure stages 2 or 3 according criteria AKIN (Acute Kidney Injury Network).
  • Hypersensibility reactions with vancomycin [ Time Frame: 30 days after randomization ]
    Skin rash, bronchospasm or anaphylaxis / anaphylactic shock.
  • Length of ICU stay [ Time Frame: 30 days after randomization ]
    Therapeutic efficacy with less length of ICU stay
  • Time of treatment with the antimicrobial [ Time Frame: 30 days after randomization ]
    Therapeutic efficacy with less time of treatment with the antimicrobial
  • Length of hospitalization [ Time Frame: 30 days after randomization ]
    Therapeutic efficacy with less length of hospitalization
  • Mortality rate [ Time Frame: 30 days after randomization ]
    Therapeutic efficacy with less mortality rate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Intermittent Infusion Versus Continuous Infusion of Vancomycin on Kidney Failure in Critically Ill Patients
Official Title  ICMJE Effect of Intermittent Infusion Versus Continuous Infusion of Vancomycin on Kidney Failure in Critically Ill Patients: Randomized and Controlled Multicenter Clinical Trial.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gram-Positive Bacterial Infections
  • Nephrotoxicity
  • Sepsis
Intervention  ICMJE
  • 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 Name: Continuous infusion
  • 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 Name: Intermittent infusion
Study Arms  ICMJE
  • Active Comparator: Vancomycin continuous infusion
    Continuous infusion of vancomycin
    Intervention: Drug: Vancomycin Continuous infusion
  • Active Comparator: Vancomycin intermittent infusion
    Intermittent infusion of vancomycin
    Intervention: Drug: Vancomycin Intermittent infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 15, 2018)
222
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2022
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Juliano P Almeida, professor (5511)98149-2592 doctorjuliano@yahoo.com.br
Contact: Estela M de Oliveira, PhD student (5516)98237-7000 estela.oliveira27@hotmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03438214
Other Study ID Numbers  ICMJE 81226617.8.1001.0065
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juliano P Almeida, MD, PhD, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Juliano P Almeida, Professor University os São Paulo
Principal Investigator: Estela M de Oliveira, PhD student University os São Paulo
PRS Account University of Sao Paulo
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP