Trial Outcomes & Findings for Normoglycemia and Neurological Outcome (NCT NCT01137773)

NCT ID: NCT01137773

Last Updated: 2022-01-04

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 56 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2022-01-04

Participant Flow

Participant milestones

Measure	Intensive IV Insulin Patients received target glucose levels of 80-110 mg/dl	Conventional Insulin Treatment Subjects received conventional (150-170 mg/dl) glucose control
Overall Study STARTED	33	23
Overall Study COMPLETED	24	20
Overall Study NOT COMPLETED	9	3

Reasons for withdrawal

Measure	Intensive IV Insulin Patients received target glucose levels of 80-110 mg/dl	Conventional Insulin Treatment Subjects received conventional (150-170 mg/dl) glucose control
Overall Study Death	3	3
Overall Study Lost to Follow-up	6	0

Baseline Characteristics

Normoglycemia and Neurological Outcome

Baseline characteristics by cohort

Measure	Intensive IV Insulin n=33 Participants Patients will received IV insulin to maintain target glucose levels of 80-110 mg/dl	Convention Insulin Treatment n=23 Participants conventional (150-170 mg/dl, n = 20) glucose control	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=93 Participants	23 Participants n=4 Participants	56 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	23 Participants n=93 Participants	13 Participants n=4 Participants	36 Participants n=27 Participants
Sex: Female, Male Male	10 Participants n=93 Participants	10 Participants n=4 Participants	20 Participants n=27 Participants
Region of Enrollment United States	33 Participants n=93 Participants	23 Participants n=4 Participants	56 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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. 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

Outcome measures

Measure	Intensive IV Insulin n=24 Participants Patients will receive IV insulin to maintain target glucose levels of 80-110 mg/dl	Convention Insulin Treatment n=20 Participants conventional (150-170 mg/dl, n = 20) glucose control
Karnovsky Performance Status Scale of Functional Impairment	53 units on a scale Standard Deviation 55	60 units on a scale Standard Deviation 25

SECONDARY outcome

Timeframe: 24 h

average blood glucose concentration while the patients received insulin drip

Outcome measures

Measure	Intensive IV Insulin n=24 Participants Patients will receive IV insulin to maintain target glucose levels of 80-110 mg/dl	Convention Insulin Treatment n=20 Participants conventional (150-170 mg/dl, n = 20) glucose control
Blood Glucose Concentration	99 mg/dl blood Standard Deviation 9	138 mg/dl blood Standard Deviation 20

Adverse Events

Intensive IV Insulin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Convention Insulin Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rainer Lenhardt, MD

University Louisville

Phone: 502-228-7517

Email: rainer.lenhardt@louisville.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place