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Individualized blood pressure management during endovascular treatment of acute ischemic stroke under procedural sedation (INDIVIDUATE) – An explorative randomized controlled trial

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: To assess whether an individualized intraprocedural blood pressure managem...

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Autores principales: Chen, Min, Kronsteiner, Dorothea, Möhlenbruch, Markus A, Kieser, Meinhard, Bendszus, Martin, Wick, Wolfgang, Nagel, Simon, Ringleb, Peter A, Schönenberger, Silvia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8564155/
https://www.ncbi.nlm.nih.gov/pubmed/34746424
http://dx.doi.org/10.1177/23969873211000879
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author Chen, Min
Kronsteiner, Dorothea
Möhlenbruch, Markus A
Kieser, Meinhard
Bendszus, Martin
Wick, Wolfgang
Nagel, Simon
Ringleb, Peter A
Schönenberger, Silvia
author_facet Chen, Min
Kronsteiner, Dorothea
Möhlenbruch, Markus A
Kieser, Meinhard
Bendszus, Martin
Wick, Wolfgang
Nagel, Simon
Ringleb, Peter A
Schönenberger, Silvia
author_sort Chen, Min
collection PubMed
description 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: 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. Sample size: Randomization of 250 patients 1:1 to receive either standard or individualized blood pressure management approach. METHODS AND DESIGN: 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). Study outcomes: The primary endpoint is the modified Rankin scale assessed 90 days +/− 2 weeks after stroke onset, dichotomized by 0–2 (favorable outcome) to 3–6 (unfavorable outcome). Secondary endpoints include early neurological improvement, infarction size, and systemic physiology monitor parameters. DISCUSSION: 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.
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spelling pubmed-85641552021-11-04 Individualized blood pressure management during endovascular treatment of acute ischemic stroke under procedural sedation (INDIVIDUATE) – An explorative randomized controlled trial Chen, Min Kronsteiner, Dorothea Möhlenbruch, Markus A Kieser, Meinhard Bendszus, Martin Wick, Wolfgang Nagel, Simon Ringleb, Peter A Schönenberger, Silvia Eur Stroke J Study Protocol 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: 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. Sample size: Randomization of 250 patients 1:1 to receive either standard or individualized blood pressure management approach. METHODS AND DESIGN: 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). Study outcomes: The primary endpoint is the modified Rankin scale assessed 90 days +/− 2 weeks after stroke onset, dichotomized by 0–2 (favorable outcome) to 3–6 (unfavorable outcome). Secondary endpoints include early neurological improvement, infarction size, and systemic physiology monitor parameters. DISCUSSION: 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. SAGE Publications 2021-03-04 2021-09 /pmc/articles/PMC8564155/ /pubmed/34746424 http://dx.doi.org/10.1177/23969873211000879 Text en © European Stroke Organisation 2021 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Study Protocol
Chen, Min
Kronsteiner, Dorothea
Möhlenbruch, Markus A
Kieser, Meinhard
Bendszus, Martin
Wick, Wolfgang
Nagel, Simon
Ringleb, Peter A
Schönenberger, Silvia
Individualized blood pressure management during endovascular treatment of acute ischemic stroke under procedural sedation (INDIVIDUATE) – An explorative randomized controlled trial
title Individualized blood pressure management during endovascular treatment of acute ischemic stroke under procedural sedation (INDIVIDUATE) – An explorative randomized controlled trial
title_full Individualized blood pressure management during endovascular treatment of acute ischemic stroke under procedural sedation (INDIVIDUATE) – An explorative randomized controlled trial
title_fullStr Individualized blood pressure management during endovascular treatment of acute ischemic stroke under procedural sedation (INDIVIDUATE) – An explorative randomized controlled trial
title_full_unstemmed Individualized blood pressure management during endovascular treatment of acute ischemic stroke under procedural sedation (INDIVIDUATE) – An explorative randomized controlled trial
title_short Individualized blood pressure management during endovascular treatment of acute ischemic stroke under procedural sedation (INDIVIDUATE) – An explorative randomized controlled trial
title_sort individualized blood pressure management during endovascular treatment of acute ischemic stroke under procedural sedation (individuate) – an explorative randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8564155/
https://www.ncbi.nlm.nih.gov/pubmed/34746424
http://dx.doi.org/10.1177/23969873211000879
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