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Delayed Versus Early Antihyperglycemic Treatment for Severe Stroke

ConditionSevere Stroke
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Wannan Medical College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intravenous insulin

    Drug

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Delayed Antihyperglycemic GroupExperimental treatment 1 intervention
Group B: Early Antihyperglycemic GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Poor Functional Outcome at 90 Days

Proportion of patients with modified Rankin Scale (mRS) score ≥ 3, assessed at 90 days post-randomization. The mRS is a 7-point scale ranging from 0 (no symptoms) to 6 (death).

Time frame
from enrollment to day 90 post-enrollment

Secondary outcomes

1

All-cause Mortality at ICU Discharge or Day 14

Proportion of patients who die from any cause by ICU discharge or Day 14, whichever occurs first

Time frame
from admission to ICU discharge within 14 days
2

Neurological Status at ICU Discharge or Day 14

Neurological function assessed by National Institutes of Health Stroke Scale (NIHSS) score. NIHSS ranges from 0 to 42, with higher scores indicating more severe neurological deficits

Time frame
from admission to ICU discharge within 14 days
3

Level of Consciousness at ICU Discharge or Day 14

Level of consciousness assessed by Glasgow Coma Scale (GCS) score. GCS ranges from 3 to 15, with lower scores indicating impaired consciousness

Time frame
from admission to ICU discharge within 14 days
4

All-cause Mortality at 90 Days

Proportion of patients who die from any cause within 90 days post-randomization

Time frame
from admission to discharge at 90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Wannan Medical College

Lead sponsor

Source ClinicalTrials.gov
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