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Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial (SHINE)

Primary Purpose

Acute Ischemic Stroke, Diabetes, Hyperglycemia

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring stroke, diabetes, hyperglycemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 years or older
Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more cerebral vascular territories. Neuroimaging must be done to exclude intracranial hemorrhage (ICH).
Randomization must be within 12 hours after stroke symptom onset and treatment is recommended, but not required, to begin within 3 hours after hospital arrival. If time of symptom onset is unclear or patient is awakening with stroke symptoms, the time of onset will be the time the patient was last known to be normal.
Known history of type 2 diabetes mellitus and glucose >110 mg/dL OR admission blood glucose ≥150 mg/dL in those w/o known diabetes mellitus
Baseline NIHSS score of 3-22
Pre-stroke modified Rankin Scale score = 0 for patients with an NIHSS score of 3-7. Pre-stroke modified Rankin Scale score = 0 or 1 for patients with an NIHSS score of 8-22.
Able to provide a valid informed consent to be in the study (self or their authorized legally accepted representative). The approved consent form must be signed and dated in accordance with federal and institutional guidelines.

Exclusion Criteria:

Known history of type 1 diabetes mellitus
Substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment
Having received experimental therapy for the enrollment stroke. IV tPA (up to 4.5 hrs) or IA tPA are allowed as are IA therapies including use of FDA cleared devices. Non FDA cleared devices are considered experimental and are excluded.
Pregnant or breast-feeding at the time of study entry
Other serious conditions that make the patient unlikely to survive 90 days
Inability to follow the protocol or return for the 90 day follow up
Renal dialysis (including hemo or peritoneal dialysis)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IV insulin drip with target glucose 80 mg/dL - 130 mg/dL

Sub Q insulin to keep glucose less than 180 mg/dL

Arm Description

The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range.

This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL

Outcomes

Primary Outcome Measures

Number of Participants With a Favorable Modified Rankin Scale (Yes/No)

Favorable for the primary efficacy outcome is defined as modified Rankin Scale (mRS) score of 0 in patients with mild stroke (baseline NIHSS 3-7), mRS 0 or 1 in patients with moderate stroke (baseline NIHSS 8-14), and mRS 0, 1 or 2 in patients with severe stroke (baseline NIHSS 15-22) at 90 days with a pre-specified range of acceptable days of 76 -120 days. The mRS is a stroke outcome scale used to assess functional status after stroke. It consists of seven levels (0-6) where 0 indicates no residual symptoms at all, 5 indicates severe disability and 6 indicates death. The person collecting the mRS score was to be blinded to the participant's treatment group assignment.

Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL)

Severe hypoglycemia (blood glucose < 40mg/dL) is the primary safety outcome and will be measured during the 72 hour treatment period.

Secondary Outcome Measures

Number of Participants With a Favorable NIHSS

The NIHSS (National Institutes of Health Stroke Scale) score ranges from 0 to 42, with higher scores indicating greater neurological deficits. A favorable NIHSS was defined as a score of 0 or 1 on the NIHSS at 90 days post randomization.

Number of Participants With a Favorable Barthel Index

Favorable outcomes for the Barthel Index was defined as a score of 95-100 on the BI at 90 days post randomization. Barthel - Barthel Index for Activities of Daily Living (ADL) assesses functional independence, generally in stroke patients. Scores range from 0-100 with higher scores indicating greater ability to perform activities of daily living.

Stroke Specific Quality of Life (SSQOL)

Stroke Specific Quality of Life. Scores range from 1-5 with higher scores indicating better quality of life

Full Information

NCT ID

NCT01369069

First Posted

June 6, 2011

Last Updated

December 13, 2019

Sponsor

University of Virginia

Collaborators

Neurological Emergencies Treatment Trials Network (NETT), Medical University of South Carolina, National Institute of Neurological Disorders and Stroke (NINDS)

1. Study Identification

Unique Protocol Identification Number

NCT01369069

Brief Title

Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

Acronym

SHINE

Official Title

Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

April 2012 (Actual)

Primary Completion Date

November 19, 2018 (Actual)

Study Completion Date

November 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Virginia

Collaborators

Neurological Emergencies Treatment Trials Network (NETT), Medical University of South Carolina, National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed Description

Eligible subjects must be randomized within 12 hours of stroke symptom onset and either have type 2 diabetes and glucose concentrations of over 110 mg/dL or no history of diabetes and glucose concentrations of 150 mg/dL or higher on initial evaluation. The enrolling sites include the Neurological Emergencies Treatment Trials (NETT) sites as well as non NETT sites from all over the United States. The study evaluates the safety and efficacy of targeted glucose control (treatment group - IV insulin with target 80-130 mg/dl) verses control therapy of sub q insulin plus basal insulin with target glucose less than 180 mg/ dL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ischemic Stroke, Diabetes, Hyperglycemia

Keywords

stroke, diabetes, hyperglycemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

1151 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IV insulin drip with target glucose 80 mg/dL - 130 mg/dL

Arm Type

Experimental

Arm Description

The intervention arm will have a targeted glucose concentration of 80-130 mg/dL. IV insulin drip will be titrated to keep glucose concentration in this range.

Arm Title

Sub Q insulin to keep glucose less than 180 mg/dL

Arm Type

Active Comparator

Arm Description

This standard care arm will get sub q insulin sliding scale to keep glucose concentration less than 180 mg/dL

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

Continuous intravenous insulin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

Sliding scale insulin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Participants With a Favorable Modified Rankin Scale (Yes/No)

Description

Time Frame

90 days (-14/+30 days)

Title

Number of Participants With Severe Hypoglycemia (Blood Glucose < 40mg/dL)

Description

Severe hypoglycemia (blood glucose < 40mg/dL) is the primary safety outcome and will be measured during the 72 hour treatment period.

Time Frame

72 hours

Secondary Outcome Measure Information:

Title

Number of Participants With a Favorable NIHSS

Description

Time Frame

Follow up (Max 164 days)

Title

Number of Participants With a Favorable Barthel Index

Description

Time Frame

Follow up (Max 164 days)

Title

Stroke Specific Quality of Life (SSQOL)

Description

Stroke Specific Quality of Life. Scores range from 1-5 with higher scores indicating better quality of life

Time Frame

Follow up (Max 164 days)

Other Pre-specified Outcome Measures:

Title

Death

Description

Death from any cause

Time Frame

90 days (+30 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 years or older Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more cerebral vascular territories. Neuroimaging must be done to exclude intracranial hemorrhage (ICH). Randomization must be within 12 hours after stroke symptom onset and treatment is recommended, but not required, to begin within 3 hours after hospital arrival. If time of symptom onset is unclear or patient is awakening with stroke symptoms, the time of onset will be the time the patient was last known to be normal. Known history of type 2 diabetes mellitus and glucose >110 mg/dL OR admission blood glucose ≥150 mg/dL in those w/o known diabetes mellitus Baseline NIHSS score of 3-22 Pre-stroke modified Rankin Scale score = 0 for patients with an NIHSS score of 3-7. Pre-stroke modified Rankin Scale score = 0 or 1 for patients with an NIHSS score of 8-22. Able to provide a valid informed consent to be in the study (self or their authorized legally accepted representative). The approved consent form must be signed and dated in accordance with federal and institutional guidelines. Exclusion Criteria: Known history of type 1 diabetes mellitus Substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment Having received experimental therapy for the enrollment stroke. IV tPA (up to 4.5 hrs) or IA tPA are allowed as are IA therapies including use of FDA cleared devices. Non FDA cleared devices are considered experimental and are excluded. Pregnant or breast-feeding at the time of study entry Other serious conditions that make the patient unlikely to survive 90 days Inability to follow the protocol or return for the 90 day follow up Renal dialysis (including hemo or peritoneal dialysis)

Overall Study Officials: