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PK of Piperacillin/Tazobactam in Adults Undergoing ECMO

Sponsor
Columbia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03467854
Collaborator
(none)
10
Enrollment
1
Location
59
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is designed to provide preliminary data to determine if concentrations of piperacillin/tazobactam change in patients with severe respiratory failure receiving extracorporeal membrane oxygenation (ECMO). The investigators hypothesize that patients will have significant changes in concentration measurements, specifically an increased clearance rate and increased volume of distribution, during ECMO as compared to critically ill patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In a healthy patient, the lungs provide oxygen to the blood and remove carbon dioxide. However, in patients with severe lung failure, blood may not adequately be delivered to the lungs, or the lungs may not adequately supply blood with oxygen. In this case, patients may require assistance from a machine to help provide this oxygen. Extracorporeal membrane oxygenation (ECMO) is a device that acts as an artificial lung, allowing the patient to recover from their illness. Patients receiving support from ECMO are often put in a medically induced coma while their lungs heal. Certain drugs may stick to the internal surfaces of the machine; therefore leading to decreased concentrations. Patients receiving ECMO often require antimicrobials to treat severe infections. However, little data exist concerning the likely changes in drug concentrations from drug circuit interactions in adult patients receiving ECMO.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pharmacokinetics (PK) of Piperacillin/Tazobactam in Adults Undergoing Extracorporeal Membrane Oxygenation (ECMO)
    Actual Study Start Date :
    Jan 1, 2019
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    VV ECMO

    Patients 18 years of age or older, initiated on veno-venous (VV) ECMO for acute respiratory distress syndrome, and receiving piperacillin/tazobactam.Four blood samples will be obtained after the first dose of piperacillin/tazobactam: one sample before the second dose, 30-minutes, 2-hours, and 6-hours into the infusion. An additional four blood samples will be drawn on day 2 at the same time points.

    Outcome Measures

    Primary Outcome Measures

    1. Change in clearance rate [Up to 2 days after the first dose of piperacillin/tazobactam]

    2. Change in volume of distribution [Up to 2 days after the first dose of piperacillin/tazobactam]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients 18 years of age or older

    • Initiated on VV ECMO for acute respiratory distress syndrome

    • Receiving piperacillin/tazobactam

    Exclusion Criteria:

    • Pregnancy

    • Massive blood transfusion (10 units or more of of PRBC) within a 24-hour period

    • Prisoners

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 NewYork-Presbyterian Hospital New York New York United States 10032

    Sponsors and Collaborators

    • Columbia University

    Investigators

    • Principal Investigator: Daniel Brodie, MD, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daniel Brodie, Professor of Medicine, Columbia University
    ClinicalTrials.gov Identifier:
    NCT03467854
    Other Study ID Numbers:
    • AAAR7200
    First Posted:
    Mar 16, 2018
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Daniel Brodie, Professor of Medicine, Columbia University
    ECMO
    Antimicrobials
    Additional relevant MeSH terms:
    Respiratory Insufficiency
    Hypoxia

    Study Results

    No Results Posted as of Jul 20, 2022