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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

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).

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Estimated Study Start Date : April 28, 2018
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Intermittent infusion




Primary Outcome Measures :
  1. Acute renal failure [ Time Frame: 30 days after randomization ]
    Acute renal failure stage 1 according criteria AKIN (Acute Kidney Injury Network).


Secondary Outcome Measures :
  1. Acute renal failure [ Time Frame: 30 days after randomization ]
    Acute renal failure stages 2 or 3 according criteria AKIN (Acute Kidney Injury Network).

  2. Hypersensibility reactions with vancomycin [ Time Frame: 30 days after randomization ]
    Skin rash, bronchospasm or anaphylaxis / anaphylactic shock.

  3. Length of ICU stay [ Time Frame: 30 days after randomization ]
    Therapeutic efficacy with less length of ICU stay

  4. Time of treatment with the antimicrobial [ Time Frame: 30 days after randomization ]
    Therapeutic efficacy with less time of treatment with the antimicrobial

  5. Length of hospitalization [ Time Frame: 30 days after randomization ]
    Therapeutic efficacy with less length of hospitalization

  6. Mortality rate [ Time Frame: 30 days after randomization ]
    Therapeutic efficacy with less mortality rate



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438214


Contacts
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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

Locations
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Brazil
Faculty of Medicine University os São Paulo Not yet recruiting
São Paulo, SP, Brazil, 01246-903
Contact: Estela M de Oliveira, investigator    11 98237 7000 ext +55    estela.oliveira27@hotmail.com   
Contact: Juliano P Almeida, professor    11 98149 2592 ext +55    doctorjuliano@yahoo.com.br   
Sponsors and Collaborators
University of Sao Paulo
Investigators
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Principal Investigator: Juliano P Almeida, Professor University os São Paulo
Principal Investigator: Estela M de Oliveira, PhD student University os São Paulo

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Responsible Party: Juliano P Almeida, MD, PhD, Research associate, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03438214     History of Changes
Other Study ID Numbers: 81226617.8.1001.0065
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

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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

Keywords provided by Juliano P Almeida, MD, PhD, University of Sao Paulo:
Vancomycin infusion
critical ill patients
MRSA

Additional relevant MeSH terms:
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Vancomycin
Critical Illness
Renal Insufficiency
Bacterial Infections
Gram-Positive Bacterial Infections
Disease Attributes
Pathologic Processes
Kidney Diseases
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents