Monitoring of Cerebral Blood Flow in Patients on Extracorporeal Membrane Oxygenation

NCT05303363 | Recruiting

• 1 other identifier: W21_486 # 21.539
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Extracorporeal Membrane Oxygenation Complication; Cerebral Circulatory Failure

Outcome Measures

Primary Outcomes (1)

• Cerebral Blood Flow (CBF) velocity using Transcranial Doppler Ultrasound (cm/sec)

  Change in CBF after correction of extracellular (arterial) pH during ECMO

  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.

Study Arms (1)

VV-ECMO

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.

Device: VV-ECMO

Interventions

VV-ECMO DEVICE

VV-ECMO is indicated in case of severe respiratory failure refractory to other therapies. Indications for VV-ECMO include severe pneumonia, acute respiratory distress syndrome (ARDS) (a.o. due to COVID-19) or near-drowning. ECMO is considered a 'last resort' therapy, in which other maneuvers - such as prone positioning and neuromuscular blockage - have shown to be insufficient. Patients are generally receiving invasive mechanical ventilation and are almost always unconscious, since due to the severe respiratory failure, high doses of sedatives and neuromuscular blockage are often applied to prevent further ventilator-induced damage. After the decision for VV-ECMO is made, the patient is directly cannulated in the ICU or OR following standard protocols.

VV-ECMO

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam-Zuidoost, 1105, Netherlands

RECRUITING

Study Officials

• Alexander Vlaar, MD PhD MBA

  Department of Intensive Care, Amsterdam UMC, location AMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Vlaar, MD PhD MBA

CONTACT

25846; a.p.vlaar@amsterdamumc.nl

Rogier Immink, MD PhD

CONTACT

27182; mailto:r.v.immink@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 31, 2022
• Study Start: December 15, 2021
• Primary Completion: June 15, 2025
• Study Completion: August 15, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

NL (1)