NCT04578288

Individualized Blood Pressure Management During Endovascular Stroke Treatment

Individualized Blood Pressure Management During Endovascular Treatment of Acute Ischemic Stroke Under Procedural Sedation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: University Hospital Heidelberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
PROCEDURE	INDIVIDUALIZED BLOOD PRESSURE MANAGEMENT DURING ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE UNDER PROCEDURAL SEDATION	The individual target range is defined as: bSBP ± 10 mmHg. The lowest possible SBP target range is 100-120 mmHg. The highest SBP target range is determined on the basis of whether patients receive concurrent IV fibrinolytic therapy or not. In patients where IV fibrinolytic therapy is applied, the highest SBP range is 160-180 mmHg, in patients without concurrent fibrinolytic therapy the highest SBP range is 180-200 mmHg.

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-10-21
• Completion: 2022-10-21
• First posted: 2020-10-08
• Last updated: 2022-11-08

Locations

1 site across 1 country: Germany