Clinical trial NCT05303363: Monitoring of Cerebral Blood Flow in Patients on Extracorporeal Membrane Oxygenation
Official title: Monitoring of Cerebral Blood Flow in Patients on Extracorporeal Membrane Oxygenation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Extracorporeal Membrane Oxygenation Complication
Cerebral Circulatory Failure
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients with a suspected indication for VV-ECMO. ECMO will be provided according to local guidelines. In the Amsterdam UMC, location AMC, next to VV-ECMO, veno-arterial (VA-ECMO) is also provided. For this study, only patients on VV-ECMO will be included.

Brief summary: Venovenous extracorporeal membrane oxygenation (VV-ECMO) is a supportive therapy, indicated in case of severe, possibly reversible pulmonary failure, refractory to conventional therapies. Despite advances, morbidity and mortality remain high. Severe neurological complications can occur during ECMO, but their exact etiology is not well understood. It is hypothesized that fast correction of severe hypercapnia, a common indication for venovenous ECMO, may be detrimental for the brain. The supposed mechanism is that fast correction of hypercapnia may result in massive cerebral vasoconstriction and impaired cerebral blood flow (CBF). In this prospective, observational study the aim is to quantify change in CBF during routine initial correction of severe hypercapnia during VV-ECMO. Furthermore, the investigators will record any other hemodynamic changes during VV-ECMO. The hypothesis is that a larger decline in PaCO2 will result in a larger decline of CBF.


Eligibility criteria: Inclusion Criteria: in order to be eligible to participate in this study, a subject must meet all of the following criteria:

* High suspicion of an indication for VV-ECMO;
* Arterial line present to enable blood sampling;
* Older than 18 years.

Exclusion Criteria:

* Subjects will be excluded if the cerebral blood flow cannot be measured using the transcranial Doppler
* VA-ECMO or ECPR;
* No possibility for neuromonitoring measurements due to technical difficulties, e.g. post-craniotomy, unsuitable transcranial window;
* No possibility for neuromonitoring measurements due to circumstantial difficulties, e.g. ECPR;
* Contraindications for ECMO;
* ECMO is initiated in another center.

Primary outcomes:
measure: Cerebral Blood Flow (CBF) velocity using Transcranial Doppler Ultrasound (cm/sec)
timeFrame: Before,during and after start of VV-ECMO,consisting of:starting 1 hour in advance of ECMO initiation, continuing until a maximum of 1 hour after the last change in SGF. 24 hours after ECMO initiation another measurement of 30 minutes will be performed.
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam-Zuidoost
country: Netherlands
facility: Amsterdam UMC
Study officials:
affiliation: Department of Intensive Care, Amsterdam UMC, location AMC
name: Alexander Vlaar, MD PhD MBA
role: PRINCIPAL_INVESTIGATOR
References: