Trial Outcomes & Findings for Early Insulin and Development of ARDS (NCT NCT00605696)

NCT ID: NCT00605696

Last Updated: 2018-05-07

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: Measured at Day 1, 3 and 7
• Results posted on: 2018-05-07

Participant Flow

Participant milestones

Measure	Early Insulin Group Participants will receive insulin to target glucose of 80-110 mg/dl within 6-12 hours after presenting to ED for up to 48 hours after admission to the ICU.	Control Group Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission.
Overall Study STARTED	7	11
Overall Study COMPLETED	7	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Early Insulin and Development of ARDS

Baseline characteristics by cohort

Measure	Early Insulin Group n=7 Participants Participants will receive IIT within 6-12 hours after presenting to ED. Insulin : Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU.	Control Group n=11 Participants Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care. Insulin : Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Age, Continuous	74 years STANDARD_DEVIATION 21 • n=5 Participants	70 years STANDARD_DEVIATION 18 • n=7 Participants	72 years STANDARD_DEVIATION 19 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	11 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at Day 1, 3 and 7

Population: Although blood samples were collected, there were no bioassays perfomed and therefore no data were collected from any study participants.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at Day 3

Population: Change in Murray Lung Injury score from Day 3 to Day 0 (baseline)

Murray Lung Injury Score is a continuous score that quantifies the severity of lung injury and consist of components related to severity of hypoxia, pulmonary compliance, peep, and radiologic abnormalities. The scores range between 0 - 4. The higher the score, the greater the degree and severity of lung injury. The scale runs from 0-4, with 0 being the minimum and 4 the maximum score.

Outcome measures

Measure	Early Insulin Group n=7 Participants Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) in the ED and after ICU admission for up to 48 hours.	Control Group n=11 Participants Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care.
Murray Lung Injury Score	0.333 units on a scale Standard Deviation 0.81	0.323 units on a scale Standard Deviation 1.03

Adverse Events

Early Insulin Group

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Early Insulin Group n=7 participants at risk Participants will receive IIT within 6-12 hours after presenting to ED. Insulin : Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU.	Control Group n=11 participants at risk Participants will receive insulin to target 150-180 mg/dl for 48 hours after ICU admission followed by usual clinical care. Insulin : Participants will receive intravenous insulin to target tight glycemic control (80 to 110 mg/dL) either in the ED or 48 hours after admission to the ICU.
Endocrine disorders Hypoglycemia	28.6% 2/7 • Number of events 2	0.00% 0/11

Additional Information

Michelle Ng Gong, MD, MS

Albert Einstein College of Medicine of Yeshiva University

Phone: 718 920 5464

Email: mgong@montefiore.org

Results disclosure agreements

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