Normoglycemia and Neurological Outcome

NCT01137773 | Terminated Phase 4 Results

• 1 other identifier: UofL IRB #562.06
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute, Non-traumatic Subarachnoid Hemorrhage; Intraparenchymal Hemorrhage; Brain Injuries

Keywords

SAH (Subarachnoid Hemorrhage); Brain Hemorrhage; Traumatic Brain Injury; SAH; ICH

Outcome Measures

Primary Outcomes (1)

• Karnovsky Performance Status Scale of Functional Impairment

  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. Normal activity with effort; some signs or symptoms of disease - 80. Requires occasional assistance, but is able to care for most of his personal needs - 60. Disabled; requires special care and assistance - 40. Very sick; hospital admission necessary; active supportive treatment necessary- 20. Dead- 0

  3 months

Secondary Outcomes (1)

• Blood Glucose Concentration

  24 h

Study Arms (2)

Intensive IV Insulin

EXPERIMENTAL

Patients will receive IV insulin to maintain target glucose levels of 80-110 mg/dl

Drug: Insulin

Conventional Insulin Treatment

ACTIVE COMPARATOR

Patents will receive conventional IV insulin treatment with target glucose levels of 150-170 mg/dl

Drug: Conventional insulin treatment

Interventions

Insulin DRUG

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.

Intensive IV Insulin

Conventional insulin treatment DRUG

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.

Conventional Insulin Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Brain Injuries; Subarachnoid Hemorrhage; Intracranial Hemorrhages; Brain Injuries, Traumatic

Interventions

Insulin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Rainer Lenhardt, MD
• Organization: University Louisville

rainer.lenhardt@louisville.edu

502-228-7517

Study Officials

• Rainer Lenhardt, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 4, 2010
• Study Start: January 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: January 4, 2022
• Results First Posted: August 10, 2017

Record last verified: 2021-12

Locations

US (1)