ECMO: Optimization of Its Use

Extracorporeal Membrane Oxygenation Complication Clinical Trial

Official title:

Extracorporeal Membrane Oxygenation(ECMO): Optimization of Its Use

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02280460
• Other study ID #: 2014-194
• Status: Active, not recruiting
• Start date: September 2014
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To create a local registry for ECMO patients.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 750
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Age<18
• Known prisoner of the state

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation Complication

Locations

Country	Name	City	State
United States	Spectrum Health	Grand Rapids	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Renzo Loyaga Rendon	Spectrum Health Hospitals

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		1 year
Secondary	all cause mortality		48 hours
Secondary	In-house mortality		30 day