Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

Summary

The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized, controlled clinical trial of 1400 patients that will include approximately 60 enrolling sites. The study hypotheses are that treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80mg/dL - 130 mg/dL) will be safe and result in improved 3 month outcome after stroke.

Conditions

• Acute Ischemic Stroke
• Diabetes
• Hyperglycemia

Interventions

DRUG

IV insulin to maintain target glucose concentration of 80-130 mg/dL

Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target.

DRUG

Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL

Sliding scale sub q insulin given will be given up to 4 times per day based on glucose concentration. It will be given only if glucose concentration greater than or equal to 180 mg/dL.

Sponsors & Collaborators

• Neurological Emergencies Treatment Trials Network (NETT)

  collaborator NETWORK

• Medical University of South Carolina

  collaborator OTHER

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• University of Virginia

  lead OTHER

Principal Investigators

• Karen C Johnston, MD, MSc · University of Virginia

• Christiana Hall, MD, MS · UT Southwestern

• Askiel Bruno, MD, MS · Augusta University

• Valerie Durkalski, PhD · Medical University of South Carolina

• William Barsan, MD · University of Michigan

• Kevin Barrett, MD · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2018-11-19

Completion

2018-11-19

Countries

• United States

Study Locations