Treatment of hyperglycemia in ischemic stroke (THIS): A randomized pilot trial

Askiel Bruno, Thomas A. Kent, Bruce M. Coull, Ravi R. Shankar, Chandan Saha, Kyra J. Becker, Brett M. Kissela, Linda S. Williams

Research output: Contribution to journalArticle

174 Citations (Scopus)

Abstract

BACKGROUND AND PURPOSE - Hyperglycemia may worsen brain injury during acute cerebral infarction. We tested the feasibility and tolerability of aggressive hyperglycemia correction with intravenous insulin compared with usual care during acute cerebral infarction. METHODS - We conducted a randomized, multicenter, blinded pilot trial for patients with cerebral infarction within 12 hours after onset, a baseline glucose value ≥8.3 mmol/L (≥150 mg/dL), and a National Institutes of Health Stroke Scale score of 3 to 22. Patients were randomized 2:1 to aggressive treatment with continuous intravenous insulin or subcutaneous insulin QID as needed (usual care). Target glucose levels were <7.2 mmol/L (<130 mg/dL) in the aggressive-treatment group and <11.1 mmol/L (<200 mg/dL) in the usual-care group. Glucose was monitored every 1 to 2 hours, and the protocol treatments continued for up to 72 hours. Final clinical outcomes were assessed at 3 months. RESULTS - We randomized 46 patients (31 to aggressive treatment and 15 to usual care). All patients in the aggressive-treatment group and 11 (73%) in the usual-care group had diabetes (P=0.008). Glucose levels were significantly lower in the aggressive-treatment group throughout protocol treatment (7.4 vs 10.5 mmol/L [133 vs 190 mg/dL], P<0.001). Hypoglycemia <3.3 mmol/L (<60 mg/dL) occurred only in the aggressive-treatment group (11 patients, 35%), 4 (13%) of whom had brief symptoms, including only 1 (3%) neurologic. Final clinical outcomes were nonsignificantly better in the aggressive-treatment group. CONCLUSIONS - The intravenous insulin protocol corrected hyperglycemia during acute cerebral infarction significantly better than usual care without major adverse events and should be investigated in a clinical efficacy trial.

Original languageEnglish (US)
Pages (from-to)384-389
Number of pages6
JournalStroke
Volume39
Issue number2
DOIs
StatePublished - Feb 1 2008

Fingerprint

Hyperglycemia
Stroke
Cerebral Infarction
Insulin
Glucose
Clinical Protocols
Therapeutics
National Institutes of Health (U.S.)
Hypoglycemia
Brain Injuries
Nervous System
Clinical Trials

Keywords

  • Brain infarction
  • Diabetes mellitus
  • Hyperglycemia
  • Insulin

ASJC Scopus subject areas

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialized Nursing

Cite this

Bruno, A., Kent, T. A., Coull, B. M., Shankar, R. R., Saha, C., Becker, K. J., ... Williams, L. S. (2008). Treatment of hyperglycemia in ischemic stroke (THIS): A randomized pilot trial. Stroke, 39(2), 384-389. https://doi.org/10.1161/STROKEAHA.107.493544

Treatment of hyperglycemia in ischemic stroke (THIS) : A randomized pilot trial. / Bruno, Askiel; Kent, Thomas A.; Coull, Bruce M.; Shankar, Ravi R.; Saha, Chandan; Becker, Kyra J.; Kissela, Brett M.; Williams, Linda S.

In: Stroke, Vol. 39, No. 2, 01.02.2008, p. 384-389.

Research output: Contribution to journalArticle

Bruno, A, Kent, TA, Coull, BM, Shankar, RR, Saha, C, Becker, KJ, Kissela, BM & Williams, LS 2008, 'Treatment of hyperglycemia in ischemic stroke (THIS): A randomized pilot trial', Stroke, vol. 39, no. 2, pp. 384-389. https://doi.org/10.1161/STROKEAHA.107.493544
Bruno, Askiel ; Kent, Thomas A. ; Coull, Bruce M. ; Shankar, Ravi R. ; Saha, Chandan ; Becker, Kyra J. ; Kissela, Brett M. ; Williams, Linda S. / Treatment of hyperglycemia in ischemic stroke (THIS) : A randomized pilot trial. In: Stroke. 2008 ; Vol. 39, No. 2. pp. 384-389.
@article{985b3dd2f06041cea94c0012cb38de36,
title = "Treatment of hyperglycemia in ischemic stroke (THIS): A randomized pilot trial",
abstract = "BACKGROUND AND PURPOSE - Hyperglycemia may worsen brain injury during acute cerebral infarction. We tested the feasibility and tolerability of aggressive hyperglycemia correction with intravenous insulin compared with usual care during acute cerebral infarction. METHODS - We conducted a randomized, multicenter, blinded pilot trial for patients with cerebral infarction within 12 hours after onset, a baseline glucose value ≥8.3 mmol/L (≥150 mg/dL), and a National Institutes of Health Stroke Scale score of 3 to 22. Patients were randomized 2:1 to aggressive treatment with continuous intravenous insulin or subcutaneous insulin QID as needed (usual care). Target glucose levels were <7.2 mmol/L (<130 mg/dL) in the aggressive-treatment group and <11.1 mmol/L (<200 mg/dL) in the usual-care group. Glucose was monitored every 1 to 2 hours, and the protocol treatments continued for up to 72 hours. Final clinical outcomes were assessed at 3 months. RESULTS - We randomized 46 patients (31 to aggressive treatment and 15 to usual care). All patients in the aggressive-treatment group and 11 (73{\%}) in the usual-care group had diabetes (P=0.008). Glucose levels were significantly lower in the aggressive-treatment group throughout protocol treatment (7.4 vs 10.5 mmol/L [133 vs 190 mg/dL], P<0.001). Hypoglycemia <3.3 mmol/L (<60 mg/dL) occurred only in the aggressive-treatment group (11 patients, 35{\%}), 4 (13{\%}) of whom had brief symptoms, including only 1 (3{\%}) neurologic. Final clinical outcomes were nonsignificantly better in the aggressive-treatment group. CONCLUSIONS - The intravenous insulin protocol corrected hyperglycemia during acute cerebral infarction significantly better than usual care without major adverse events and should be investigated in a clinical efficacy trial.",
keywords = "Brain infarction, Diabetes mellitus, Hyperglycemia, Insulin",
author = "Askiel Bruno and Kent, {Thomas A.} and Coull, {Bruce M.} and Shankar, {Ravi R.} and Chandan Saha and Becker, {Kyra J.} and Kissela, {Brett M.} and Williams, {Linda S.}",
year = "2008",
month = "2",
day = "1",
doi = "10.1161/STROKEAHA.107.493544",
language = "English (US)",
volume = "39",
pages = "384--389",
journal = "Stroke",
issn = "0039-2499",
publisher = "Lippincott Williams and Wilkins",
number = "2",

}

TY - JOUR

T1 - Treatment of hyperglycemia in ischemic stroke (THIS)

T2 - A randomized pilot trial

AU - Bruno, Askiel

AU - Kent, Thomas A.

AU - Coull, Bruce M.

AU - Shankar, Ravi R.

AU - Saha, Chandan

AU - Becker, Kyra J.

AU - Kissela, Brett M.

AU - Williams, Linda S.

PY - 2008/2/1

Y1 - 2008/2/1

N2 - BACKGROUND AND PURPOSE - Hyperglycemia may worsen brain injury during acute cerebral infarction. We tested the feasibility and tolerability of aggressive hyperglycemia correction with intravenous insulin compared with usual care during acute cerebral infarction. METHODS - We conducted a randomized, multicenter, blinded pilot trial for patients with cerebral infarction within 12 hours after onset, a baseline glucose value ≥8.3 mmol/L (≥150 mg/dL), and a National Institutes of Health Stroke Scale score of 3 to 22. Patients were randomized 2:1 to aggressive treatment with continuous intravenous insulin or subcutaneous insulin QID as needed (usual care). Target glucose levels were <7.2 mmol/L (<130 mg/dL) in the aggressive-treatment group and <11.1 mmol/L (<200 mg/dL) in the usual-care group. Glucose was monitored every 1 to 2 hours, and the protocol treatments continued for up to 72 hours. Final clinical outcomes were assessed at 3 months. RESULTS - We randomized 46 patients (31 to aggressive treatment and 15 to usual care). All patients in the aggressive-treatment group and 11 (73%) in the usual-care group had diabetes (P=0.008). Glucose levels were significantly lower in the aggressive-treatment group throughout protocol treatment (7.4 vs 10.5 mmol/L [133 vs 190 mg/dL], P<0.001). Hypoglycemia <3.3 mmol/L (<60 mg/dL) occurred only in the aggressive-treatment group (11 patients, 35%), 4 (13%) of whom had brief symptoms, including only 1 (3%) neurologic. Final clinical outcomes were nonsignificantly better in the aggressive-treatment group. CONCLUSIONS - The intravenous insulin protocol corrected hyperglycemia during acute cerebral infarction significantly better than usual care without major adverse events and should be investigated in a clinical efficacy trial.

AB - BACKGROUND AND PURPOSE - Hyperglycemia may worsen brain injury during acute cerebral infarction. We tested the feasibility and tolerability of aggressive hyperglycemia correction with intravenous insulin compared with usual care during acute cerebral infarction. METHODS - We conducted a randomized, multicenter, blinded pilot trial for patients with cerebral infarction within 12 hours after onset, a baseline glucose value ≥8.3 mmol/L (≥150 mg/dL), and a National Institutes of Health Stroke Scale score of 3 to 22. Patients were randomized 2:1 to aggressive treatment with continuous intravenous insulin or subcutaneous insulin QID as needed (usual care). Target glucose levels were <7.2 mmol/L (<130 mg/dL) in the aggressive-treatment group and <11.1 mmol/L (<200 mg/dL) in the usual-care group. Glucose was monitored every 1 to 2 hours, and the protocol treatments continued for up to 72 hours. Final clinical outcomes were assessed at 3 months. RESULTS - We randomized 46 patients (31 to aggressive treatment and 15 to usual care). All patients in the aggressive-treatment group and 11 (73%) in the usual-care group had diabetes (P=0.008). Glucose levels were significantly lower in the aggressive-treatment group throughout protocol treatment (7.4 vs 10.5 mmol/L [133 vs 190 mg/dL], P<0.001). Hypoglycemia <3.3 mmol/L (<60 mg/dL) occurred only in the aggressive-treatment group (11 patients, 35%), 4 (13%) of whom had brief symptoms, including only 1 (3%) neurologic. Final clinical outcomes were nonsignificantly better in the aggressive-treatment group. CONCLUSIONS - The intravenous insulin protocol corrected hyperglycemia during acute cerebral infarction significantly better than usual care without major adverse events and should be investigated in a clinical efficacy trial.

KW - Brain infarction

KW - Diabetes mellitus

KW - Hyperglycemia

KW - Insulin

UR - http://www.scopus.com/inward/record.url?scp=39349094881&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=39349094881&partnerID=8YFLogxK

U2 - 10.1161/STROKEAHA.107.493544

DO - 10.1161/STROKEAHA.107.493544

M3 - Article

C2 - 18096840

AN - SCOPUS:39349094881

VL - 39

SP - 384

EP - 389

JO - Stroke

JF - Stroke

SN - 0039-2499

IS - 2

ER -