NCT07526181

Brief Summary

for patients connected to VA ECMO due to cardiogenic shock, monitoring:

  • ECMO duration.
  • Need for oxygen therapy/mechanical ventilation.
  • ICU survival.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
15mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

April 20, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

April 4, 2026

Last Update Submit

April 10, 2026

Conditions

Mechanical Circulatory Support

Keywords

VA-ECMONIRSnative COPECMO flow

Outcome Measures

Primary Outcomes (1)

  • correlation between native cardiac output/ Extracorporeal membrane oxygenation flow ratio and regional cerebral tissue oxygen saturation

    from date of randomization until the date of ending the ECMO support (assessed up to 100 weeks)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patient, aged more than 18 years old with cardiogenic shock unresponsive to conventional medical treatment and supported with VA ECMO.

You may qualify if:

  • Age ≥ 18 years
  • Patients supported with veno-arterial ECMO.
  • Presence of a pulmonary artery catheter.
  • Expected ECMO support ≥ 24 hours.
  • Patient with good echocardiographic window.

You may not qualify if:

  • Pre-existing severe neurological injury (e.g. massive stroke, traumatic brain injury).
  • Intracranial pathology affecting NIRS reliability.
  • Facial or scalp conditions preventing NIRS probe placement.
  • ECMO duration \< 48 hours.
  • Poor echocardiographic window.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Doaa Roshdy Abdul satar, assistant lecturer

CONTACT

2001024588594doaa.elenany@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

April 4, 2026

First Posted

April 13, 2026

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04