NCT03467854

Terminated

PK of Piperacillin/Tazobactam in Adults Undergoing ECMO

Columbia University Source

Columbia University

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

AAAR7200

Study Type

observational

Actual enrollment (reported)

2

Locations

1 country

Sites

1

Timeline

Study Start

January 1, 2019

Actual (reported)

Primary Completion

September 24, 2024

Actual (reported)

Study Completion

September 24, 2024

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 2 participants
Study completion date: September 24, 2024
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 10, 2018
Actual (reported)
First Posted
March 16, 2018
Actual (reported)
Study Start
January 1, 2019
Actual (reported)
Primary Completion
September 24, 2024
Actual (reported)
Study Completion
September 24, 2024
Actual (reported)

Last Updated: September 26, 2024
Status Verified: September 2024
Last Update Submitted: September 24, 2024

Conditions

Acute Respiratory Failure With Hypoxia

Keywords

ECMOAntimicrobials

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

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability 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

Sponsors & Collaborators

Columbia University
Otherlead

Study Sites (1)

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York, 10032, United States

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

Enrollment

2 participants (actual enrollment reported by the registry).

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

Actual (reported)

NCT02050217

NAVA Helmet in Pediatric Respiratory Failure

Phase 3Unknown

NCT02167542

Positive Pressure During Bronchoscopy

Not ApplicableCompleted

NCT03311087

Conduct of Nasal High Flow Oxygen in Acute Respiratory Failure

Unknown

NCT01937884

Supplemental Parenteral Nutrition in Pediatric Respiratory Failure

Phase 2Terminated

NCT03021824

Severe ARDS: Generating Evidence

Completed

NCT03326830

Prehospital High-Flow Nasal Oxygen Therapy

Not ApplicableCompleted

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

Contact the study team to confirm eligibility.

Primary Completion

September 24, 2024

Actual (reported)

Study Completion

September 24, 2024

Actual (reported)

Last Updated

September 26, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing: Will not share

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT03467854
Data provider: ClinicalTrials.gov
Source updated: 2024-09-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:15 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

VV ECMO

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations