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Normoglycemia and Neurological Outcome

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ClinicalTrials.gov Identifier: NCT01137773
Recruitment Status : Terminated (Slow enrollment)
First Posted : June 4, 2010
Results First Posted : August 10, 2017
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Rainer Lenhardt, University of Louisville

June 3, 2010
June 4, 2010
April 9, 2017
August 10, 2017
August 10, 2017
January 2007
December 2014   (Final data collection date for primary outcome measure)
Karnovsky Performance Status Scale of Functional Impairment [ Time Frame: 3 months ]
The Karnofsky Performance Scale Index allows patients to be classified as to their functional impairment. It can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses. Patients are assigned a value from 0 to 100 based on the following definitions: Normal no complaints; no evidence of disease - 100 Able to carry on normal activity; minor signs or symptoms of disease- 90 Normal activity with effort; some signs or symptoms of disease - 80 Cares for self; unable to carry on normal activity or to do active work - 70 Requires occasional assistance, but is able to care for most of his personal needs - 60 Requires considerable assistance and frequent medical care - 50 Disabled; requires special care and assistance - 40 Severely disabled; hospital admission is indicated although death not imminent - 30 Very sick; hospital admission necessary; active s
Glasgow Outcomes Scale Extended score [ Time Frame: 12 months ]
The Glasgow Outcome Scale (GOS) is the most widely used measure for traumatic brain injury and other non-traumatic brain injuries and is favored over other measures such as disability rating scale.
Complete list of historical versions of study NCT01137773 on ClinicalTrials.gov Archive Site
Blood Glucose Concentration [ Time Frame: 24 h ]
average blood glucose concentration while the patients received insulin drip
Karnofsky Performance Scale (KPS) [ Time Frame: 12 months ]
The Karnofsky Performance Scale (KPS) was originally intended for debilitating diseases such as terminal cancer, but it is currently also used for evaluation of quality of life and long term rehabilitation.
Not Provided
Not Provided
 
Normoglycemia and Neurological Outcome
Does Maintenance of Normoglycemia Change Neurological Outcome in Patients Recovering From Traumatic Brain Injury and Subarachnoid or Intraparenchymal Hemorrhage?

Brain injury patients who meet defined criteria will be assigned to intensive insulin treatment (target blood glucose levels of 10-110 mg/dl) or conventional IV insulin treatment (target glucose of 150-170 mg/dl). Follow up will occur at 3, 6 and 12 months. The primary outcome measure will be neurological outcome at 12 months according to Karnofsky Performance Scale (KPS). A general view of outcome will also be presented as favorable (good recovery+ moderate disability), unfavorable (severely disabled+ vegetative state), and dead.

Secondary outcome measures will be blood glucose levels and death.The investigators will also record systemic complications like pulmonary emboli, pulmonary edema, myocardial infarction, ventricular arrhythmias, and pneumonia.

Demographic data, social and medical histories, and clinical features at onset will be obtained via patient or family interview shortly after admission . We want to get the patients enrolled in our protocol as soon as possible because we believe that hyperglycemia levels greater than 200 mg/dl is a secondary insult that should be prevented as early as possible. However, a twelve-hour period after ICU admission is necessary for initial diagnosis and assessment of the patient's status in order to identify the patient as a potential study subject and to get consent from the patient's legal representative.

Within twelve hours of ICU admission, qualifying patients will be randomized one of the two groups. Randomization will be based on computer-generated codes that will be maintained in sequentially numbered opaque envelopes. The randomization will be stratified according to the severity of neurological injury based on GCS. The three stratification groups will be GCS=6-8, GCS=9-11 and GCS=12-14. Randomization will be done using random sized blocks within stratum, and patients will be randomized within stratum to either:

  1. Intensive intravenous insulin treatment (Target glucose levels of 80-110 mg/dl)
  2. Conventional intravenous insulin treatment (Target glucose levels of 150-170 mg/dl)

All patients in the trial will have blood taken hourly for glucose analysis, regardless of their designated group. Adjustments of the insulin dose will be based on measurements of capillary blood glucose level. The interval between the glucose samples will be increased when patients satisfy discharge criteria from the intensive care unit. The insulin dose adjustments will be made by a team of intensive care nurses, assisted by a study nurse who is not otherwise involved in the clinical care of the patients. RBC transfusions, if necessary, will be administered one unit at a time, and the patient's hemoglobin concentration will be measured before and after each transfusion.

All patients enrolled in the study will receive saline infusion supplemented with potassium. An orogastric or nasogastric feeding tube (Dobhoff tube) will be inserted. Enteral feeding will be started per feeding protocol with the goal of starting on day one. After insertion of a nasogastric or orogastric tube, tube position will be verified with abdominal x-ray. Enteral feeding will be instituted with 25 to 30 nonprotein kilocalories per kilogram of body weight per 24 hours and a balanced composition (including 0.13 to 0.26 g of nitrogen per kilogram per 24 hours and 20 to 40 percent of nonprotein in the form of lipids). 69 Formula used will be recorded. Patients will be fed continuously starting at a rate of 25 ml/hour. If continuous enteral feeding cannot be instituted or has to be stopped and enteral nutrition is anticipated to be interrupted for more than 7 days, total parenteral nutrition will be initiated. Patients will be allowed to progress to a regular oral diet after they have passed a swallowing study.

The underlying neurological conditions will be managed by the neurosurgical team according to the protocols of the Department of Neurosurgery of the University of Louisville.

When participating patients' physiological statuses have stabilized and the need for ICU monitoring and care is no longer necessary, they will be discharged to a lower level of care (in accordance with the 1999 guidelines of Task Force of the American College of Critical Care Medicine, Society of Critical Care Medicine). Upon discharge from ICU, patients in all groups will be treated with subcutaneous insulin according to established transition guidelines.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
  • Acute, Non-traumatic Subarachnoid Hemorrhage
  • Intraparenchymal Hemorrhage
  • Brain Injuries
  • Drug: Insulin
    All patients in the trial will have blood taken hourly for glucose analysis, regardless of their designated group. Adjustments of the insulin dose will be based on measurements of capillary blood glucose level.
  • Drug: Conventional insulin treatment
    All patients in the trial will have blood taken hourly for glucose analysis , regardless of their designated group. Adjustments of the insulin dose will be based on measurements of capillary blood glucose level.
  • Experimental: Intensive IV Insulin
    Patients will receive IV insulin to maintain target glucose levels of 80-110 mg/dl
    Intervention: Drug: Insulin
  • Active Comparator: Conventional Insulin Treatment
    Patents will receive conventional IV insulin treatment with target glucose levels of 150-170 mg/dl
    Intervention: Drug: Conventional insulin treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
56
360
December 2015
December 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • non-traumatic SAH, ICH, or TBI
  • Glasgow Coma Scale between 6 and 14
  • admitted to an ICU of University of Louisville Hospital

Exclusion Criteria:

  • Patients <18 and >80 years
  • GCS Motor score <4 or an overall GCS score of 15
  • diabetic patients who suffer from dialysis-dependent diabetic nephropathy
  • patients with multiple injuries
  • patients who would have been classified as ASA 3 status prior to their acute neurological event
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01137773
UofL IRB #562.06
No
Not Provided
Not Provided
Rainer Lenhardt, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Rainer Lenhardt, MD University of Louisville
University of Louisville
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP