Hyperglycemia, Stroke
Conditions
Keywords
stroke, acute ischemic stroke, hyperglycemia, glucose, insulin, insulin and potassium therapy, GIK
Brief summary
The purpose of this study is to assess the feasibility, safety and preliminary efficacy of the use of insulin infusions as treatment for hyperglycemic acute ischemic stroke patients.
Detailed description
Ischemic stroke is a common, devastating and costly disease. Half of acute stroke patients have elevated glucose levels upon admission to the hospital, and hyperglycemia is associated with poor outcome for post-stroke patients. It is unclear if treatment of hyperglycemia or glucose lowering improves outcome, however, in animal stroke models and other human conditions, aggressive glucose lowering is beneficial. The goal of this multicenter trial is to determine if tight control of blood glucose is beneficial in hyperglycemic patients with acute ischemic stroke. In the trial, researchers will compare intravenous (IV) glucose insulin and potassium (GIK) therapy plus meal insulin to control therapy in 72 stroke patients. Participants will be randomly assigned to one of three groups-(1) the control group with a target glucose level of \<300mg/dL; (2) the tight control GIK plus meal insulin group with a target of \<110mg/dL; or (3) the loose control GIK plus meal insulin group with a target of \<200mg/dL-with all groups avoiding glucose levels of \<70mg/dL. The specific aims of this study are to collect preliminary data on the safety and feasibility of GIK for treatment of hyperglycemia in acute stroke patients, and to collect preliminary data comparing tight GIK therapy with loose GIK therapy and control therapy. Information learned in this study will compliment ongoing work and allow for maximum efficiency in the design of future treatment trials.
Interventions
OTHERstandard care
usual care
DRUGIV glucose insulin and potassium, GIK
The treatment intervention includes glucose, insulin, potassium infusion or standard therapy.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older. * Clinical diagnosis of ischemic stroke defined as acute neurological deficit occurring in one or more major vessels. * Must arrive at hospital and be able to begin treatment within 2 hours of established eligibility and this must be within 24 hours of symptom onset. - - Patients unable to report symptom onset time or those awakening with symptoms must use the time last known to be well as the onset time. * Admission plasma glucose of \> 110 mg/dL.
Exclusion criteria
* Renal dysfunction as defined by a serum creatinine of \>/=2.5 mg/dL at enrollment. * Substantial pre-existing neurological or psychiatric illness that would confound neurological assessment. * Patients who have received experimental therapy for the enrollment stroke. * Pregnant females. * Patients with other severe life threatening conditions that makes them unlikely to survive 90 days. * Patients who are unable to follow the protocol or come back for 90-day followup. * Patient has condition for which insulin infusion is the usual practice or the treating physician feels that there is an indication for insulin infusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemic Events | up to 5 days | hypoglycemic events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Favorable 3 Month Modified Rankin | 3 months | 3 month functional outcomes by modified Rankin (0 to 1) dichotomized as favorable versus not favorable outcome. Construct is functional handicap. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic Hypoglycemia | up to 5 days | symptomatic hypoglycemia (glucose \< 55 mg/dL)during treatment period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tight Control Group target glucose level 70-110 mg/dL | 24 |
| Loose Control Group target glucose level 70 - 200 mg/dL | 25 |
| Usual Care Group target level 70 - 300 mg/dL | 25 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | d/c prior to prim outcome, 3 m f/u done | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Tight Control Group | Loose Control Group | Usual Care Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 17 Participants | 13 Participants | 43 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 8 Participants | 12 Participants | 31 Participants |
| Region of Enrollment United States | 24 participants | 25 participants | 25 participants | 74 participants |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 10 Participants | 33 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 15 Participants | 41 Participants |
Outcome results
Primary
Hypoglycemic Events
hypoglycemic events
Time frame: up to 5 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tight Control Group | Hypoglycemic Events | 7 participants |
| Loose Control Group | Hypoglycemic Events | 1 participants |
| Usual Care Group | Hypoglycemic Events | 1 participants |
Secondary
Favorable 3 Month Modified Rankin
3 month functional outcomes by modified Rankin (0 to 1) dichotomized as favorable versus not favorable outcome. Construct is functional handicap.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tight Control Group | Favorable 3 Month Modified Rankin | 42 percentage of participants |
| Loose Control Group | Favorable 3 Month Modified Rankin | 25 percentage of participants |
| Usual Care Group | Favorable 3 Month Modified Rankin | 33 percentage of participants |
Other Pre-specified
Symptomatic Hypoglycemia
symptomatic hypoglycemia (glucose \< 55 mg/dL)during treatment period
Time frame: up to 5 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tight Control Group | Symptomatic Hypoglycemia | 0 participants |
| Loose Control Group | Symptomatic Hypoglycemia | 1 participants |
| Usual Care Group | Symptomatic Hypoglycemia | 0 participants |
Post Hoc
Target Glucose Concentration
glucose in target range in first 24 hours
Time frame: first 24 hours after initiation of treatment
Population: Per protocol no analysis of this endpoint was performed in the usual care group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tight Control Group | Target Glucose Concentration | 10 participants |
| Loose Control Group | Target Glucose Concentration | 22 participants |