PK of Piperacillin/Tazobactam in Adults Undergoing ECMO

NCT ID: NCT03467854

Last Updated: 2024-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2024-09-24

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Respiratory Failure With Hypoxia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Darryl Abrams

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Darryl Abrams, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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AAAR7200

Identifier Type: -

Identifier Source: org_study_id

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