Individualized Blood Pressure Management During Endovascular Stroke Treatment (INDIVIDUATE)

  • End date
    Jan 29, 2023
  • participants needed
  • sponsor
    University Hospital Heidelberg
Updated on 29 May 2022


Optimal blood pressure management during endovascular treatment of acute ischemic stroke is not well established. Several retrospective data indicate, that there is a U-shaped relationship of admission blood pressure and functional outcome, where either very high or very low blood pressure are disadvantageous for the patient. Low blood pressure might lead to hypoperfusion in ischemic areas (i.e. penumbra) and to larger infarction sizes, while on the other hand, maladaptive high blood pressure might lead to edema and hemorrhage. Retrospective data investigating intraprocedural blood pressure and its influence on outcome is limited. Some studies indicate that hypotensive blood pressure drops from the level of the admission blood pressure lead to a worse outcome. Intraprocedural hypotensive drops are common during endovascular thrombectomy due to application of necessary sedative drugs for agitated stroke patients. We aim to investigate whether individualized blood pressure management with patient-specific blood pressure targets situated at the level during presentation might be associated with better functional outcome compared with general blood pressure targets for patients during thrombectomy. For this purpose, we plan to perform this single center, parallel-group, open-label randomized controlled trial with blinded endpoint evaluation (PROBE).

Condition Acute Ischemic Stroke
Clinical Study IdentifierNCT04578288
SponsorUniversity Hospital Heidelberg
Last Modified on29 May 2022


Yes No Not Sure

Inclusion Criteria

Decision for thrombectomy according to local protocol for acute recanalizing stroke treatment
Age 18 years or older, either sex
National Institutes of Health Stroke Scale (NIHSS) ≥ 8
Acute ischemic stroke in the anterior circulation with isolated or combined occlusion of: Internal carotid artery (ICA) and/or middle cerebral artery (MCA)
Informed consent by the patient him-/herself or his/her legal representative obtainable within 72 h of treatment

Exclusion Criteria

Intracerebral hemorrhage
Coma on admission (Glasgow Coma Scale ≤ 8)
Severe respiratory instability, loss of airway protective reflexes or vomiting on admission, where primary intubation and general anesthesia is deemed necessary
Intubated state before randomization
Severe hemodynamic instability (e.g. due to decompensated heart insufficiency)
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