Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke

Официальное название

Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke: A Prospective, Randomized, Controlled, Open-Label, Blinded-Endpoint Clinical Trial

Обзор

This study is a exploratory, randomized, controlled, open-label, blinded-endpoint Phase II clinical trial designed to evaluate whether delaying antihyperglycemic treatment for 72 hours improves neurological outcomes in patients with severe stroke and hyperglycemia. A total of 426 patients with severe stroke (including ischemic stroke, intracerebral hemorrhage, or aneurysmal subarachnoid hemorrhage) within 24 hours of onset and blood glucose \>10 mmol/L at randomization will be enrolled. Participants will be randomly assigned in a 1:1 ratio to either delayed antihyperglycemic treatment (initiated on Day 4) or early antihyperglycemic treatment (initiated on Day 1). Glycemic control targets (7.8-10.0 mmol/L) and insulin therapy follow current clinical guidelines. The primary outcome is the incidence of poor functional outcome (modified Rankin Scale score ≥ 3) at 90 days. Secondary outcomes include mortality, NIHSS score, GCS score, ICU length of stay, and safety events such as hypoglycemia and infections. The study aims to provide evidence on the optimal timing of glycemic control in severe stroke patients with stress hyperglycemia.

Вмешательства

• Препарат Intravenous insulin
  Insulin administered intravenously to maintain blood glucose between 7.8-10.0 mmol/L. Timing of initiation differs by arm: Day 1 for early group, Day 4 for delayed group.

Первичные конечные точки

• Poor Functional Outcome at 90 Days [Срок оценки: from enrollment to day 90 post-enrollment]

Вторичные конечные точки (7)

• All-cause Mortality at ICU Discharge or Day 14 [Срок оценки: from admission to ICU discharge within 14 days]
• Neurological Status at ICU Discharge or Day 14 [Срок оценки: from admission to ICU discharge within 14 days]
• Level of Consciousness at ICU Discharge or Day 14 [Срок оценки: from admission to ICU discharge within 14 days]
• All-cause Mortality at 90 Days [Срок оценки: from admission to discharge at 90 days]
• Length of ICU Stay [Срок оценки: From admission to ICU discharge, an average of 11 days]
• Incidence of Adverse Events [Срок оценки: From randomization to ICU discharge or Day 14, whichever occurs first]
• Incidence of Serious Adverse Events [Срок оценки: From randomization to 90 day post-randomization]

Критерии участия

Критерии включения

• Age ≥ 18 years;
• Severe stroke within 24 hours of onset, meeting one of the following criteria:

1）Severe ischemic stroke: Glasgow Coma Scale (GCS) score ≤ 12 or National Institutes of Health Stroke Scale (NIHSS) score ≥ 15 or CT hypodensity > 1/3 of middle cerebral artery (MCA) territory; 2）Severe intracerebral hemorrhage: Supratentorial hematoma volume ≥ 30 mL (thalamic hemorrhage ≥ 10 mL) or infratentorial hematoma volume ≥ 10 mL (brainstem hemorrhage ≥ 5 mL); 3）Aneurysmal subarachnoid hemorrhage; 3. Blood glucose level > 10 mmol/L at randomization; 4. Signed informed consent.

Критерии исключения

• Known history of type 1 diabetes mellitus;
• Known allergy to insulin or diagnosis of insulinoma;
• Pre-stroke modified Rankin Scale (mRS) score > 1;
• Hemodynamic instability refractory to medical treatment (systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg);
• Decompensated heart failure (New York Heart Association \[NYHA\] class III or IV);
• Estimated glomerular filtration rate (eGFR) < 30 mL/min;
• Expected survival < 90 days due to malignancy;
• Participation in another drug or device clinical trial within the past 30 days;
• Women of childbearing potential who refuse to use effective contraception despite negative pregnancy test, pregnant women, or breastfeeding women.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07501533 · 202603

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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