Individualized Blood Pressure Management During Endovascular Stroke Treatment (INDIVIDUATE)

University Hospital Heidelberg

Status: Completed

Conditions: Acute Ischemic Stroke

Treatments: Procedure: INDIVIDUALIZED BLOOD PRESSURE MANAGEMENT DURING ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE UNDER PROCEDURAL SEDATION

Study type: Interventional

Funder types: Other

Identifiers

NCT04578288

Heidelberg University Hospital

Details and patient eligibility

About

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).

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Standard Blood Pressure management

Active Comparator group

Description:

The standard blood pressure management is maintenance of intraprocedural pre-recanalization SBP between 140-180 mmHg for all patients who receive endovascular thrombectomy for acute ischemic stroke in anterior circulation.

Treatment:

Procedure: INDIVIDUALIZED BLOOD PRESSURE MANAGEMENT DURING ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE UNDER PROCEDURAL SEDATION

Individualized Blood Pressure management

Experimental group

Description:

The study intervention would be maintaining the intraprocedural pre-recanalization blood pressure in individualized SBP target ranges depending on the systolic blood pressure of the patient at presentation (=baseline SBP or bSBP).

Treatment:

Procedure: INDIVIDUALIZED BLOOD PRESSURE MANAGEMENT DURING ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE UNDER PROCEDURAL SEDATION