Individualized blood pressure management during endovascular treatment of acute ischemic stroke under procedural sedation (INDIVIDUATE) - An explorative randomized controlled trial.
Ischemic stroke
blood pressure
endovascular therapy
Journal
European stroke journal
ISSN: 2396-9881
Titre abrégé: Eur Stroke J
Pays: England
ID NLM: 101688446
Informations de publication
Date de publication:
Sep 2021
Sep 2021
Historique:
received:
25
01
2021
accepted:
16
02
2021
entrez:
8
11
2021
pubmed:
9
11
2021
medline:
9
11
2021
Statut:
ppublish
Résumé
Optimal blood pressure is not well established during endovascular therapy of acute ischemic stroke. Applying standardized blood pressure target values for every stroke patient might be a suboptimal approach. To assess whether an individualized intraprocedural blood pressure management with individualized blood pressure target ranges might pose a better strategy for the outcome of the patients than standardized blood pressure targets. We conduct an explorative single-center randomized controlled trial with a PROBE (parallel-group, open-label randomized controlled trial with blinded endpoint evaluation) design. In the control group, intraprocedural systolic blood pressure target range is 140-180 mmHg. The intervention group is the individualized approach, which is maintaining the intraprocedural systolic blood pressure at the level on presentation (±10 mmHg). An individualized approach for blood pressure management during thrombectomy could lead to a better outcome for stroke patients. The trial is registered at clinicaltrials.gov as 'Individualized Blood Pressure Management During Endovascular Stroke Treatment (INDIVIDUATE)' under NCT04578288.
Sections du résumé
BACKGROUND
BACKGROUND
Optimal blood pressure is not well established during endovascular therapy of acute ischemic stroke. Applying standardized blood pressure target values for every stroke patient might be a suboptimal approach.
AIM
OBJECTIVE
To assess whether an individualized intraprocedural blood pressure management with individualized blood pressure target ranges might pose a better strategy for the outcome of the patients than standardized blood pressure targets.
METHODS AND DESIGN
METHODS
We conduct an explorative single-center randomized controlled trial with a PROBE (parallel-group, open-label randomized controlled trial with blinded endpoint evaluation) design. In the control group, intraprocedural systolic blood pressure target range is 140-180 mmHg. The intervention group is the individualized approach, which is maintaining the intraprocedural systolic blood pressure at the level on presentation (±10 mmHg).
DISCUSSION
CONCLUSIONS
An individualized approach for blood pressure management during thrombectomy could lead to a better outcome for stroke patients. The trial is registered at clinicaltrials.gov as 'Individualized Blood Pressure Management During Endovascular Stroke Treatment (INDIVIDUATE)' under NCT04578288.
Identifiants
pubmed: 34746424
doi: 10.1177/23969873211000879
pii: 10.1177_23969873211000879
pmc: PMC8564155
doi:
Banques de données
ClinicalTrials.gov
['NCT04578288']
Types de publication
Journal Article
Langues
eng
Pagination
276-282Informations de copyright
© European Stroke Organisation 2021.
Déclaration de conflit d'intérêts
Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Peter Ringleb received honoraria for advisory boards and lecture fees from Boehringer Ingelheim, Bayer, Pfizer and Daichii Sankyo, not related to the topic of the manuscript. Markus A Möhlenbruch received honoraria for lectures including service on speakers bureaus from Medtronic, MicroVention, Stryker (money paid to the institution) and has grants/grants pending from Balt, Medtronic and MicroVention, not related to the topic of the manuscript. Simon Nagel consults Brainomix, has a grant from Cerenovus and received payment for lectures including service on Speakers Bureaus from Pfizer and Boehringer Ingelheim, not related to the topic of the manuscript.
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