Individualized Blood Pressure Management During Endovascular Stroke Treatment

Acute Ischemic Stroke Clinical Trial

— INDIVIDUATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04578288
• Other study ID #: Heidelberg University Hospital
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: October 21, 2022

Study information

• Verified date: November 2022
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 21, 2022
• Est. primary completion date: October 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Germany	Department of Neurology, University Hospital Heidelberg	Heidelberg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

References & Publications (5)

Löwhagen Hendén P, Rentzos A, Karlsson JE, Rosengren L, Sundeman H, Reinsfelt B, Ricksten SE. Hypotension During Endovascular Treatment of Ischemic Stroke Is a Risk Factor for Poor Neurological Outcome. Stroke. 2015 Sep;46(9):2678-80. doi: 10.1161/STROKEAHA.115.009808. Epub 2015 Jul 14. — View Citation

Petersen NH, Ortega-Gutierrez S, Wang A, Lopez GV, Strander S, Kodali S, Silverman A, Zheng-Lin B, Dandapat S, Sansing LH, Schindler JL, Falcone GJ, Gilmore EJ, Amin H, Cord B, Hebert RM, Matouk C, Sheth KN. Decreases in Blood Pressure During Thrombectomy Are Associated With Larger Infarct Volumes and Worse Functional Outcome. Stroke. 2019 Jul;50(7):1797-1804. doi: 10.1161/STROKEAHA.118.024286. Epub 2019 Jun 4. — View Citation

Rasmussen M, Schönenberger S, Hendèn PL, Valentin JB, Espelund US, Sørensen LH, Juul N, Uhlmann L, Johnsen SP, Rentzos A, Bösel J, Simonsen CZ; SAGA collaborators. Blood Pressure Thresholds and Neurologic Outcomes After Endovascular Therapy for Acute Ischemic Stroke: An Analysis of Individual Patient Data From 3 Randomized Clinical Trials. JAMA Neurol. 2020 May 1;77(5):622-631. doi: 10.1001/jamaneurol.2019.4838. — View Citation

Schönenberger S, Uhlmann L, Ungerer M, Pfaff J, Nagel S, Klose C, Bendszus M, Wick W, Ringleb PA, Kieser M, Möhlenbruch MA, Bösel J. Association of Blood Pressure With Short- and Long-Term Functional Outcome After Stroke Thrombectomy: Post Hoc Analysis of the SIESTA Trial. Stroke. 2018 Jun;49(6):1451-1456. doi: 10.1161/STROKEAHA.117.019709. Epub 2018 May 2. — View Citation

Whalin MK, Halenda KM, Haussen DC, Rebello LC, Frankel MR, Gershon RY, Nogueira RG. Even Small Decreases in Blood Pressure during Conscious Sedation Affect Clinical Outcome after Stroke Thrombectomy: An Analysis of Hemodynamic Thresholds. AJNR Am J Neuroradiol. 2017 Feb;38(2):294-298. doi: 10.3174/ajnr.A4992. Epub 2016 Nov 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome 90 days after stroke onset	modified Rankin scale (mRS) after 90 days dichotomized 0-2 by (favorable outcome) to 3-6 (unfavorable outcome).	90 days
Secondary	Early neurological improvement indicated by change of National Institute of Health Stroke Scale (NIHSS) Score 24 hours after admission	[NIHSS on admission - NIHSS after 24 hours]	24 hours
Secondary	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]	Infarction size 12-36 hours after symptom onset	12-36 hours
Secondary	Time of intraprocedural SBP in target range [percentage of time in target range between groin puncture and reperfusion]	Duration of thrombectomy procedure	Duration of thrombectomy procedure up to 240 minutes
Secondary	Time of intraprocedural SBP spent in treatment range ± 10 mmHg [percentage of time in range between groin puncture and reperfusion]	Duration of thrombectomy procedure	Duration of thrombectomy procedure up to 240 minutes