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OpenTrials
Completed

NCT Number: NCT04578288

Individualized Blood Pressure Management During Endovascular Stroke Treatment

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Procedure

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.

Primary outcomes

  1. 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

  1. Early neurological improvement indicated by change of National Institute of Health Stroke Scale (NIHSS) Score 24 hours after admission

    Time frame: 24 hours

    [NIHSS on admission - NIHSS after 24 hours]

  2. 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]

    Time frame: 12-36 hours

    Infarction size 12-36 hours after symptom onset

  3. Time of intraprocedural SBP in target range [percentage of time in target range between groin puncture and reperfusion]

    Time frame: Duration of thrombectomy procedure up to 240 minutes

    Duration of thrombectomy procedure

  4. Time of intraprocedural SBP spent in treatment range ± 10 mmHg [percentage of time in range between groin puncture and reperfusion]

    Time frame: Duration of thrombectomy procedure up to 240 minutes

    Duration of thrombectomy procedure

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Official study title

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

Acronym: INDIVIDUATE

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 8, 2020
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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