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Trial record 28 of 528 for:    VANCOMYCIN

Safety and TDM of Continuous Infusion Vancomycin Through Continuous Renal Replacement Therapy Solution

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ClinicalTrials.gov Identifier: NCT02663596
Recruitment Status : Recruiting
First Posted : January 26, 2016
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
The Center for Pediatric Pharmacotherapy, LLC
Information provided by (Responsible Party):
Jeffrey J. Cies, PharmD, MPH, BCPS-AQ ID, BCPPS, FCCP, FCCM, Drexel University

Brief Summary:

The purpose of this investigation is to evaluate the safety of delivering continuous infusion (CI) vancomycin in pediatric CRRT by utilizing CI via by mixing the vancomycin into the CRRT solution(s). The secondary objectives are to describe the ability to achieve therapeutic vancomycin concentrations by utilizing this new delivery technique.

Primary Objectives:

To determine whether delivering continuous infusion vancomycin mixed into the CRRT solution can maintain therapeutic levels of drug in patients being treated for proven or suspected Gram-positive bacterial infections.


Condition or disease Intervention/treatment Phase
Pediatric Continuous Renal Replacement Therapy Dialysis Renal Failure Drug: Vancomycin Phase 1

Detailed Description:

Treatment Patients deemed candidates for CRRT and antimicrobial therapy for a proven or suspected Gram-positive bacterial infection that includes vancomycin at the time of CRRT initiation or at any time during the CRRT course. If vancomycin is part of the empiric regimen or needed for definitive therapy an assessment will be made whether the vancomycin can be administered via a continuous infusion by mixing the vancomycin in the CRRT solution(s).

Intervention Administration of continuous infusion vancomycin via mixing vancomycin in the CRRT solution(s). The CRRT solution will be prepared at the time it is needed following current standard operating procedures of the Department of Pharmacy at St. Christopher's Hospital for Children for sterile product compounding. The amount of vancomycin to be added to the CRRT solution will be determined by the clinical condition such as the site of infection,infecting organism(s), and serum drug levels. The mixed solution will be infused for the duration it is prescribed for CRRT. Vancomycin is stable with the components of the CRRT solution for at least 96 hours, therefore the frequency with which each CRRT solution bag will be prepared will not exceed 96 hours.

Vancomycin dosing and concentration adjustments:

For patients started on vancomycin after initiation of CRRT, a single loading dose of 15-20 mg/kg of total body weight will be given intravenously over 60 minutes, after which the vancomycin will be added directly to the CRRT solution(s). Vancomycin will be added at a final concentration of 30 mg/L at CRRT initiation, regardless of age. For patients receiving vancomycin prior to the initiation of CRRT, if the last dose administered is > 8 hours prior to CRRT initiation, a loading dose of 15-20 mg/kg of total body weight will be given intravenously over 60 minutes, after which the vancomycin will be added directly to the CRRT solution(s). Vancomycin will be added at a final concentration of 30 mg/L at CRRT initiation, regardless of age. The first serum vancomycin level will be determined 8-12 hours after initiation of CRRT mixed with vancomycin. All serum for vancomycin concentrations determination will be obtained directly from the patient via a central line, arterial line or peripheral venipuncture and no vancomycin concentrations will obtained from the CRRT circuit for analysis.

Vancomycin concentrations in the CRRT solution(s) will be adjusted based on the initial vancomycin serum plateau level, and subsequent levels will be obtained based on these changes. The target vancomycin plateau serum concentrations range is 15-30 mg/L. If the first vancomycin plateau level obtained is within range, daily vancomycin plateau levels will be obtained for the duration the vancomycin is mixed in the CRRT solution. If the first vancomycin plateau level is not within range, the vancomycin concentration in the CRRT solution will be adjusted. Subsequent vancomycin plateau levels will be obtained 8-12 hours after the vancomycin concentration change and this process will continue until a therapeutic plateau level is obtained. Once a therapeutic plateau level is obtained, daily vancomycin plateau levels will be obtained for the duration the vancomycin is mixed in the CRRT solution.

Blood samples for vancomycin analysis will be obtained 8-12 hours after starting the CRRT solution mixed with vancomycin. Based on the first drug level obtained, changes to the concentration may be made to adjust to the desired serum concentration and serum levels will be obtained 8-12 hours after each change to the vancomycin concentration in the CRRT solution. Once a therapeutic level is obtained, serum levels will be obtained as needed but usually not more frequently than daily.

If the first vancomycin plateau level is < 10 mcg/mL, then a single, supplemental dose of 10 mg/kg of vancomycin will be given while the vancomycin CRRT concentration is being adjusted.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open-Label Study of the Safety and Therapeutic Drug Monitoring of Continuous Infusion Vancomycin Through the Addition of the Vancomycin Into the Continuous Renal Replacement Therapy Solution
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vancomycin
Patients with vancomycin mixed in the CRRT solution(s)
Drug: Vancomycin
Patient requiring CRRT and vancomycin that provide consent will be given vancomycin as a continuous infusion by mixing the vancomycin into the CRRT solution(s)
Other Name: Continuous renal replacement therapy solutions




Primary Outcome Measures :
  1. Number of patients with therapeutic vancomycin serum levels [ Time Frame: Until the end of the study, up to 33 months ]
    The CRRT circuit (tubing, filter) will be inspected and evaluated for flow rates and clotting hourly



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients eligible to participate in the study must meet all of the following criteria prior to any study-related procedure:

1. The need for continuous renal replacement therapy (CRRT) of any modality

  1. CVVH-continuous veno-venous hemofiltration
  2. CVVHD-continuous veno-venous hemodialysis
  3. CVVHDF-continuous veno-venous hemodiafiltration

2. Documented or suspected Gram-positive bacterial infection necessitating the use of vancomycin while receiving CRRT.

Exclusion Criteria

Patients will be considered ineligible if they meet any of the following criteria:

  1. History of any moderate or severe hypersensitivity or allergic reaction to vancomcyin (a history of mild rash followed by uneventful re-exposure and/or red man syndrome is not a contraindication)
  2. Any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator)
  3. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of study data
  4. Planned or prior participation in any other interventional drug study within 30 days
  5. Females that are pregnant or breastfeeding

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): NCT02663596


Contacts
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Contact: Jeffrey J Cies, PharmD, MPH 215-427-5176 jeffrey.cies@gmail.com

Locations
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United States, Pennsylvania
St. Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact: Jeffrey J Cies, PharmD, MPH, BCPS-AQ ID, BCPPS    215-427-5176    jeffrey.cies@tenethealth.com   
Sponsors and Collaborators
Drexel University
The Center for Pediatric Pharmacotherapy, LLC
Investigators
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Principal Investigator: Jeffrey J Cies, PharmD, MPH Drexel University

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Responsible Party: Jeffrey J. Cies, PharmD, MPH, BCPS-AQ ID, BCPPS, FCCP, FCCM, Pharmacy Clinical Coordinator, Critical Care and Infectious Diseases Clinical Pharmacist, Drexel University
ClinicalTrials.gov Identifier: NCT02663596     History of Changes
Other Study ID Numbers: Protocol 1510004004
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Keywords provided by Jeffrey J. Cies, PharmD, MPH, BCPS-AQ ID, BCPPS, FCCP, FCCM, Drexel University:
Pediatric
Continuous Renal Replacement Therapy
Dialysis
Therapeutic drug monitoring
Pharmacokinetics
Pharmacodynamics
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Vancomycin
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents