ECMO: Optimization of Its Use

Extracorporeal Membrane Oxygenation(ECMO): Optimization of Its Use

To create a local registry for ECMO patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Extracorporeal Membrane Oxygenation Complication

Detailed Description

To create a local registry of retrospective and prospective patients on ECMO at Spectrum Health, Butterworth campus in order to optimize the use of ECMO therapy and to create algorithms to estimate the prognosis. ECMO patients will be compared to a control group of patients. Patient mortality will be assessed in-house, at 48 hours, 3 months, and 1 year after the start of ECMO therapy.

• Study Type: Observational
• Enrollment (Estimated): 750

Contacts and Locations

• Study Contact: Name: Catherine E Kelty, PhD; Phone Number: 6163915752; Email: catherine.kelty@spectrumhealth.org
• Study Contact Backup: Name: Dana Marsy, MPH; Phone Number: 6163915756; Email: dana.marsy@spectrumhealth.org

Study Locations

• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to Spectrum Health requiring ECMO therarpy. For the control, patients in the Intensive Care Unit at Spectrum Health will be considered.

Description

Inclusion Criteria:

• Age >18
• requiring ECMO. For the control,Patients without ECMO admited to ICU.

Exclusion Criteria:

• Age<18
• Known prisoner of the state

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
VA ECMO; Patients who are placed on VA ECMO.
VV ECMO; Patients who are placed on VV ECMO.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All cause mortality	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
all cause mortality	48 hours
In-house mortality	30 day

Collaborators and Investigators

• Sponsor: Renzo Loyaga Rendon
• Collaborators: Spectrum Health Hospitals; Van Andel Research Institute
• Investigators: Principal Investigator: Renzo Loyaga-Rendon, MD,PhD, Spectrum Health Hospitals

Publications and helpful links

General Publications

• Peek GJ, Mugford M, Tiruvoipati R, Wilson A, Allen E, Thalanany MM, Hibbert CL, Truesdale A, Clemens F, Cooper N, Firmin RK, Elbourne D; CESAR trial collaboration. Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomised controlled trial. Lancet. 2009 Oct 17;374(9698):1351-63. doi: 10.1016/S0140-6736(09)61069-2. Epub 2009 Sep 15. Erratum In: Lancet. 2009 Oct 17;374(9698):1330.
• Zapol WM, Snider MT, Hill JD, Fallat RJ, Bartlett RH, Edmunds LH, Morris AH, Peirce EC 2nd, Thomas AN, Proctor HJ, Drinker PA, Pratt PC, Bagniewski A, Miller RG Jr. Extracorporeal membrane oxygenation in severe acute respiratory failure. A randomized prospective study. JAMA. 1979 Nov 16;242(20):2193-6. doi: 10.1001/jama.242.20.2193.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: October 29, 2014
• First Submitted That Met QC Criteria: October 29, 2014
• First Posted (Estimated): October 31, 2014

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 21, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2014-194

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No