PK of Piperacillin/Tazobactam in Adults Undergoing ECMO

NCT03467854 | Terminated

• 1 other identifier: AAAR7200
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure With Hypoxia

Keywords

ECMO; Antimicrobials

Outcome Measures

Primary Outcomes (2)

• Change in clearance rate

  Up to 2 days after the first dose of piperacillin/tazobactam

• Change in volume of distribution

  Up to 2 days after the first dose of piperacillin/tazobactam

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult patients receiving VV ECMO for acute respiratory distress syndrome will be assessed for inclusion into the study.

You may qualify if:

• Patients 18 years of age or older
• Initiated on VV ECMO for acute respiratory distress syndrome
• Receiving piperacillin/tazobactam

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

Study Officials

• Darryl Abrams, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 10, 2018
• First Posted: March 16, 2018
• Study Start: January 1, 2019
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)