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

Min Chen; Dorothea Kronsteiner; Markus A Möhlenbruch; Meinhard Kieser; Martin Bendszus; Wolfgang Wick; Simon Nagel; Peter A Ringleb; Silvia Schönenberger

doi:10.1177/23969873211000879

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

Eur Stroke J. 2021 Sep;6(3):276-282. doi: 10.1177/23969873211000879. Epub 2021 Mar 4.

Authors

Min Chen¹, Dorothea Kronsteiner², Markus A Möhlenbruch³, Meinhard Kieser², Martin Bendszus³, Wolfgang Wick¹, Simon Nagel¹, Peter A Ringleb¹, Silvia Schönenberger¹

Affiliations

¹ Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany.
² Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
³ Department of Neuroradiology, Heidelberg University Hospital, Heidelberg, Germany.

Abstract

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.

Keywords: Ischemic stroke; blood pressure; endovascular therapy.

Associated data

ClinicalTrials.gov/NCT04578288