Neuro-cognitive Function 1 Year Post ICU Discharge Among VV ECMO Survivors

Neurocognitive Dysfunction Clinical Trial

Official title:

Neuro-cognitive Function 1 Year Post ICU Discharge Among VV ECMO Survivors: a Prospective Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06224088
• Other study ID #: 0015-24-MMC
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: February 1, 2028

Study information

• Verified date: January 2024
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In the past three years, in the general intensive care unit in Meir medical center, 25 patients were treated with ECMO, of which two patients were treated with VA ECMO and the rest with VV ECMO. 70% of the patients survived to hospital discharge.

ECMO is indicated as a rescue therapy for patients in critical condition suffering from severe cardiac and/or respiratory failure that does not respond to conservative treatment. It can be used as a bridge to recovery or to heart/lung transplantation. ECMO was introduced in the late seventies of the pervious century. Between the years 2006-2011, partly due to the outbreak of the flu epidemic (H1N1), a 433% increase was observed in the use of ECMO worldwide in adults. In light of the outbreak of the Covid-19 epidemic in recent years, another significant increase has been observed.

There are short-term and long-term complications of ECMO. Short-term complications include bleeding, thrombosis, hemolysis, HIT, renal and neurological injuries, associated infections, and technical-mechanical problems. Long-term complications include significant physical and psychological consequences that may adversely affect the patient's daily function, especially executive function.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: February 1, 2028
• Est. primary completion date: February 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria: All patients treated with VV ECMO who survived to hospital discharge between 2021-2023 -

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Neurocognitive Dysfunction

Intervention

Other:
• VV ECMO
treatment with VV ECMO in the ICU

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurocognitive function in ECMO survivors as measured by SF-36 questionnaire	Neurocognitive function in ECMO survivors one year after hospital discharge as measured by SF-36 questionnaire	one year after hospital discharge