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  3. Cerebral microembolism in the critically ill with acute kidney injury (COMET-AKI trial): study protocol for a randomized controlled clinical trial.
 

Cerebral microembolism in the critically ill with acute kidney injury (COMET-AKI trial): study protocol for a randomized controlled clinical trial.

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BORIS DOI
10.7892/boris.113595
Date of Publication
March 21, 2018
Publication Type
Article
Division/Institute

Universitätsklinik fü...

Universitätsklinik fü...

Universitätsinstitut ...

Clinical Trials Unit ...

Universitätsklinik fü...

Contributor
Erdoes, Gabor
Universitätsklinik für Anästhesiologie und Schmerztherapie
Uehlinger, Dominikorcid-logo
Universitätsklinik für Nephrologie und Hypertonie
Kobel, Beatrice
Stucki, Monika Pia
Universitätsklinik für Anästhesiologie und Schmerztherapie
Wiest, Roland Gerhard Rudi
Universitätsinstitut für Diagnostische und Interventionelle Neuroradiologie
Stüber, Frank
Universitätsklinik für Anästhesiologie und Schmerztherapie
Fankhauser, Niklausorcid-logo
Clinical Trials Unit Bern (CTU)
Jakob, Stephan
Universitätsklinik für Intensivmedizin
Schefold, Jörg Christian
Universitätsklinik für Intensivmedizin
Subject(s)

600 - Technology::610...

Series
Trials
ISSN or ISBN (if monograph)
1745-6215
Publisher
BioMed Central
Language
English
Publisher DOI
10.1186/s13063-018-2561-3
PubMed ID
29562937
Uncontrolled Keywords

Acute kidney injury C...

Description
BACKGROUND

Microembolism is a frequent pathological event during extracorporeal renal replacement therapy (RRT). Some previous data indicate that microemboli are generated in patients who are undergoing RRT and that these may contribute to increased cerebrovascular and neurocognitive morbidity in patients with end-stage renal disease. The current trial aims to quantify the microembolic load and respective qualitative composition that effectively reaches the intracerebral circulation in critically ill patients treated with different RRT modalities for acute kidney injury (AKI).

METHODS/DESIGN

The COMET-AKI trial is a prospective, randomized controlled clinical trial with a 2-day clinical assessment period and follow-up visits at 6 and 12 months. Consecutive critically ill patients with AKI on continuous renal replacement therapy (CRRT) scheduled for a switch to intermittent renal replacement therapy (IRRT) will be randomized to either switch to IRRT within the next 24 h or continued CRRT for an additional 24 h. Cerebral microembolic load will be determined at baseline, i.e., before switch (on CRRT for both groups) and on IRRT versus CRRT, whichever group they were randomized to. The primary endpoint is defined as the difference in mean total cerebral microemboli count during the measurement period on CRRT versus IRRT following randomization. Microemboli will be assessed within the RRT circuit by a 1.5-MHz ultrasound detector attached to the venous RRT tubing and cerebral microemboli will be measured in the middle cerebral artery using a 1.6-MHz robotic transcranial Doppler system with automatic classification of Doppler signals as solid or gaseous. In addition to Doppler measurements, patients will be examined by magnetic resonance imaging and neurocognitive tests to gain better understanding into the potential morphological and clinical consequences of embolization.

DISCUSSION

The results of COMET-AKI may help to gain a better insight into RRT modality-associated differences regarding microbubble generation and the cerebral microembolic burden endured by RRT recipients. Furthermore, identification of covariates of microbubble formation and distribution may help to encourage the evolution of next-generation RRT circuits including machinery and/or filters.

TRIAL REGISTRATION

ClinicalTrials.gov, ID: NCT02621749 . Registered on 3 December 2015.
Handle
https://boris-portal.unibe.ch/handle/20.500.12422/193164
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FileFile TypeFormatSizeLicensePublisher/Copright statementContent
Erdös_COMET-AKI_Trials_2018.pdftextAdobe PDF1.59 MBAttribution (CC BY 4.0)publishedOpen
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