Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03467854
Other study ID # AAAR7200
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 2024

Study information

Verified date February 2024
Source Columbia University
Contact Darryl Abrams, MD
Phone 212-305-4141
Email da2256@cumc.columbia.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Columbia University Irving Medical Center / NewYork-Presbyterian Hospital New York New York

Sponsors (1)

Lead Sponsor Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in clearance rate Up to 2 days after the first dose of piperacillin/tazobactam
Primary Change in volume of distribution Up to 2 days after the first dose of piperacillin/tazobactam
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04681040 - Risk Stratification of COVID-19 Using Urine Biomarkers
Active, not recruiting NCT04079829 - Postoperative Respiratory Abnormalities
Completed NCT03021824 - Severe ARDS: Generating Evidence
Active, not recruiting NCT02654327 - pRotective vEntilation With Veno-venouS Lung assisT in Respiratory Failure Phase 3
Completed NCT04693403 - Adult Respiratory Failure Intervention Study Africa N/A
Recruiting NCT04368975 - ARDS Caused by COVID-19
Recruiting NCT02050217 - NAVA Helmet in Pediatric Respiratory Failure Phase 3
Recruiting NCT04912960 - PEEP in Patients With Acute Respiratory Failure
Recruiting NCT03311087 - Conduct of Nasal High Flow Oxygen in Acute Respiratory Failure
Completed NCT04664322 - High-flow Oxygen Therapy vs Non-invasive Ventilation: Comparison of Alveolar Recruitment in Acute Respiratory Failure
Completed NCT02167542 - Positive Pressure During Bronchoscopy N/A
Completed NCT03326830 - Prehospital High-Flow Nasal Oxygen Therapy N/A
Terminated NCT01937884 - Supplemental Parenteral Nutrition in Pediatric Respiratory Failure Phase 2