Individualized Blood Pressure Management During Endovascular Treatment of Acute Ischemic Stroke Under Procedural Sedation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Ischemic Stroke
- Sponsor
- University Hospital Heidelberg
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Functional outcome 90 days after stroke onset
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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).
Investigators
Dr. Silvia Schönenberger, MD
Principal Investigator, Co-principal investigator: Dr. Min Chen, MD
University Hospital Heidelberg
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Functional outcome 90 days after stroke onset
Time Frame: 90 days
modified Rankin scale (mRS) after 90 days dichotomized 0-2 by (favorable outcome) to 3-6 (unfavorable outcome).
Secondary Outcomes
- Infarction size, determined with MRI or (in case of contraindications CT scan) 12-36 h after admission on a post-interventional follow up scan [milliliter](12-36 hours)
- Early neurological improvement indicated by change of National Institute of Health Stroke Scale (NIHSS) Score 24 hours after admission(24 hours)
- Time of intraprocedural SBP in target range [percentage of time in target range between groin puncture and reperfusion](Duration of thrombectomy procedure up to 240 minutes)
- Time of intraprocedural SBP spent in treatment range ± 10 mmHg [percentage of time in range between groin puncture and reperfusion](Duration of thrombectomy procedure up to 240 minutes)