An ambitious, nationwide clinical trial led by Dr. Karen Johnston of UVA Health has provided doctors with long-needed information in regards to the importance of controlling the blood sugar levels of stroke patients after treatment with clot-busting therapy. The findings will help improve stroke care and save lives.

The SHINE study, funded by the National Institutes of Health’s National Institute of Neurological Disorders and Stroke (grant U01 NS069498), was conducted at UVA Health and 69 other hospitals nationwide. A latest evaluation of the study results, led by Andrew Southerland, MD, of UVA Health, found that top blood sugar levels shortly after thrombolysis – opening blocked arteries within the brain with a clot-busting drug – was related to a greater risk of probably fatal brain bleeds. especially in older patients with more severe strokes. These brain bleeds, called symptomatic intracerebral hemorrhages, are considered some of the dangerous complications of ischemic stroke treatment.

The study results also suggest that intensive efforts to normalize blood sugar levels by aggressively administering insulin after thrombolysis weren’t related to a reduced risk of one in every of these brain bleeds. But researchers say more research is required before a possible profit from early insulin administration might be ruled out, because it could help prevent a “cascade of tissue damage” that may trigger intracerebral hemorrhage.

That is the primary large-scale prospective clinical trial in stroke patients to offer data on the effect of high blood sugar levels on the danger of symptomatic intracerebral hemorrhage after thrombolytic therapy. “These data suggest that more attention and research must be dedicated to the treatment of high blood sugar levels in stroke patients, especially in patients at higher risk and more severe strokes.”

Andrew Southerland, M.D., stroke expert at UVA Health and UVA School of Medicine

Information in regards to the SHINE study

The Stroke Hyperglycemia Insulin Network Effort (SHINE) study was sponsored by the National Institutes of Health and led nationally by Johnston and the UVA stroke research team. Of the 1,151 participants within the SHINE 725 trial, 63% underwent thrombolysis. Barely greater than half were men and the median age was 65 years. About 80% of patients had type 2 diabetes.

Of those patients, 372 were randomly assigned to intensive insulin treatment and 353 received standard sliding scale treatment. After accounting for variables that would have influenced the outcomes, the researchers found that the intensive insulin regimen utilized in the study didn’t appear to affect the danger of intracerebral hemorrhage.

Nonetheless, they found that in the primary 12 hours after thrombolysis, each 10 mg/dL increase in mean blood sugar increased the danger of intracerebral hemorrhage by 8%. Furthermore, the time it took for patients to realize normal blood sugar levels also mattered – patients who achieved lower blood sugar levels faster (lower than or equal to 180 mg/dl) tended to do higher.

Overall, high blood sugar levels after thrombolysis were related to a greater risk of brain bleeding and poorer overall outcomes, especially early after treatment, the researchers reported.

“Probably the most essential things that patients, especially diabetics, can do to cut back their risk of stroke is to work with their doctors and adopt a way of life that keeps their blood sugar under control,” said Southerland of UVA’s Department of Neurology. “The SHINE study suggests that as healthcare providers we should always pay similar attention to high blood sugar levels after stroke treatment as we already do for other risk aspects equivalent to hypertension.”

Southerland and his colleagues say additional research is warranted to higher understand learn how to best control the blood sugar levels of thrombolysis patients, especially in patients that suffer more severe strokes. They are saying this research could improve treatment outcomes and reduce the danger of intracerebral hemorrhage.

“We hope these results will inform future clinical trials of blood sugar management in patients at higher risk and more severe strokes, especially those undergoing clot removal procedures,” Southerland said. “It’s exciting to guide this research here at UVA, where we are able to work to enhance stroke outcomes for our patients locally while helping to advance the sphere globally.”

Johnston, principal investigator of the SHINE study, was pleased to learn latest insights into best practices in stroke care. “Data from the SHINE trial proceed to tell the national stroke community about potential approaches to treating patients with hyperglycemic stroke to make sure improved outcomes,” she said. “With increasingly patients undergoing life-saving interventions for acute stroke, Dr. Southerland’s findings suggest that this patient population requires further study to find out the risks and advantages of glycemic control. The outcomes of this work fit perfectly into the brand new UVA Precision Health for Populations project.”

Results published

The scientists published their findings in a scientific journal Neurology. The article was authored by Southerland, Stephan A. Mayer, Nicole A. Chiota-McCollum, Ashley C. Bolte, Qi Pauls, L. Creed Pettigrew, Thomas P. Bleck, Mark R. Conaway and Johnston.