What is the mechanism of action of this treatment?

Extracorporeal Membrane Oxygenation (ECMO) provides critical support by oxygenating blood outside the body and removing carbon dioxide, thus allowing the heart and lungs to rest and heal. The most common treatments during ECMO include anticoagulation to prevent clotting, careful fluid management to maintain optimal blood volume and pressure, and the use of inotropes and vasopressors to support heart function. Protocolized daily assessments for readiness to wean off ECMO are essential as they help identify the earliest and safest time to discontinue ECMO support, reducing the risk of complications and improving overall outcomes. This systematic approach ensures that patients are not kept on ECMO longer than necessary, which can minimize potential adverse effects and enhance recovery.

What side effects are associated with this type of intervention?

Common side effects of Extracorporeal Membrane Oxygenation (ECMO) and related weaning protocols include bleeding, infection, and thromboembolic events. Patients may also experience complications such as hemolysis, limb ischemia, and neurological issues. Protocolized daily assessments for readiness to wean off ECMO aim to minimize these risks by ensuring patients are only liberated from ECMO when they are stable and ready, potentially reducing the duration of ECMO support and associated complications.

What prior FDA approvals exist?

The FDA has approved several devices and drugs related to the management of patients on Extracorporeal Membrane Oxygenation (ECMO). These include ECMO systems themselves, which are used to provide cardiac and respiratory support to patients whose heart and lungs are unable to function adequately. While specific drugs for weaning off ECMO are not typically the focus, supportive treatments such as anticoagulants (e.g., heparin) to prevent clotting in the ECMO circuit are commonly used. The trial on Protocolized Daily Assessment of Readiness for Liberation from VV-ECMO aims to standardize the weaning process, but does not focus on a specific drug therapy.

What other types of research exist?

Promising novel alternatives to Protocolized Daily Assessment of Readiness for Liberation from VV-ECMO for 2024 include: 1) Advanced hemodynamic monitoring technologies that provide real-time data on patient stability and readiness for weaning. 2) Personalized weaning protocols based on individual patient data and predictive analytics. 3) Integration of artificial intelligence and machine learning algorithms to predict optimal weaning times. 4) Enhanced imaging techniques to assess lung recovery and function more accurately. These approaches aim to improve patient outcomes by providing more precise and individualized assessments for ECMO weaning.

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ECMO-Free Protocol for Extracorporeal Membrane Oxygenation Management

N/A

Recruiting

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to until the date of death or the date 24 hours after decannulation, whichever came first, through study completion, an average of 2 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a routine for checking if patients on a life-support machine can safely stop using it. The goal is to improve patient outcomes and reduce costs. The study will compare this routine to the usual care methods.

Who is the study for?

This trial is for adult patients currently receiving venovenous extracorporeal membrane oxygenation (VV-ECMO) in a participating hospital unit. It's not open to pregnant women, prisoners, minors under 18 years old, those on ECMO for over 24 hours, or individuals using it as a bridge to transplant.

What is being tested?

The study compares two approaches: the 'ECMO-free protocol' which involves daily assessments to determine if patients can safely stop using VV-ECMO versus 'Usual Care' where there isn't a set protocol for weaning off. The goal is to see if structured assessments improve outcomes and reduce time on ECMO.

What are the potential side effects?

While specific side effects are not listed here, generally reducing time on VV-ECMO may decrease risks associated with long-term use such as infections or blood clots. However, premature removal could lead to inadequate respiratory support.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to until the date of death or the date 24 hours after decannulation, whichever came first, through study completion, an average of 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to until the date of death or the date 24 hours after decannulation, whichever came first, through study completion, an average of 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to until the date of death or the date 24 hours after decannulation, whichever came first, through study completion, an average of 2 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

60-day ECMO-free days

Unsafe liberation from VV-ECMO

Secondary study objectives

Duration of ECMO

Hospital-free days

ICU-free days

+3 more

Other study objectives

Duration of the intervention period (days)

Number of and specific reasons for "missed" enrollments

Number of and the specific exclusion criteria met

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: The ECMO-free Protocol groupExperimental Treatment1 Intervention

For patients assigned to the ECMO-free protocol group, the study personnel will perform the ECMO-free protocol daily from enrollment until the first of death or ECMO decannulation; results will be recorded and shared with the treatment team. Final decisions regarding decannulation will be made by treating clinicians who are aware of the results of daily ECMO-free protocolized assessments.

Group II: The Usual Care GroupActive Control1 Intervention

For patients assigned to the usual care group, ECMO weaning and assessments of readiness for ECMO decannulation will be at the discretion of treating clinicians.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Extracorporeal Membrane Oxygenation (ECMO) provides critical support by oxygenating blood outside the body and removing carbon dioxide, thus allowing the heart and lungs to rest and heal. The most common treatments during ECMO include anticoagulation to prevent clotting, careful fluid management to maintain optimal blood volume and pressure, and the use of inotropes and vasopressors to support heart function. Protocolized daily assessments for readiness to wean off ECMO are essential as they help identify the earliest and safest time to discontinue ECMO support, reducing the risk of complications and improving overall outcomes. This systematic approach ensures that patients are not kept on ECMO longer than necessary, which can minimize potential adverse effects and enhance recovery.

[Extracorporeal lung support in patients with severe respiratory failure secondary to the 2010-2011 winter seasonal outbreak of influenza A (H1N1) in Spain].