Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05303363
Other study ID # W21_486 # 21.539
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 15, 2021
Est. completion date August 15, 2025

Study information

Verified date July 2023
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Alexander Vlaar, MD PhD MBA
Phone 25846
Email a.p.vlaar@amsterdamumc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date August 15, 2025
Est. primary completion date June 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
VV-ECMO
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.

Locations

Country Name City State
Netherlands Amsterdam UMC Amsterdam-Zuidoost

Sponsors (1)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
See also
  Status Clinical Trial Phase
Recruiting NCT05486559 - The ECMO-Free Trial N/A
Recruiting NCT04674657 - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Not yet recruiting NCT05306392 - Effects of Induced Moderate Hypothermia on ARDS Patients Under Venovenous ExtraCorporeal Membrane Oxygenation N/A
Terminated NCT02280460 - ECMO: Optimization of Its Use
Completed NCT02271126 - TEG Anticoagulation Monitoring During ECMO Phase 1
Recruiting NCT05444764 - PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS
Completed NCT03659513 - The Effect of ECMO on the Pharmacokinetics of the Drugs and Their Clinical Efficacy
Not yet recruiting NCT06338345 - Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients N/A
Completed NCT05948332 - Definition and Management of Right Ventricular Injury in Adult Patients Receiving Extracorporeal Membrane Oxygenation
Recruiting NCT04273607 - Anticoagulation-free VV ECMO for Acute Respiratory Failure Phase 2/Phase 3
Not yet recruiting NCT04956497 - Registry Study of Extracorporeal Cardiopulmonary Resuscitation (eCPR) in China
Completed NCT04052230 - Evolution of Diaphragm Thickness Under Veno-arterial ECMO
Terminated NCT04524585 - Partial Neuromuscular Blockade in Acute Respiratory Distress Syndrome N/A
Completed NCT04620005 - Impact of Extra Corporal Membrane Oxygenation Services on Burnout Development in Intensive Care Units.
Recruiting NCT05721105 - Evaluation of Long-term Quality of Life in Children Supported With ExtraCorporeal Membrane Oxygenation (ECMO)
Recruiting NCT06095518 - DIC Markers and Thrombin Generation Parameters in Patients on ECMO Support: a Pilot Study
Recruiting NCT03965208 - Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation Phase 4
Not yet recruiting NCT05814094 - Red Blood Cell Transfusion in ECMO - A Feasibility Trial N/A
Not yet recruiting NCT06319677 - PK/PD Study of Anti-Infective Drugs in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation Treatment
Completed NCT05338593 - Therapy and Outcome of Prolonged Veno-venous ECMO Therapy of Critically Ill ARDS Patients.