Critically Ill, Hypoglycemia
Conditions
Keywords
Intensive insulin therapy (IIT), Insulin infusion, Tight glycemic control, Intensive Care Units
Brief summary
The goal of this present proposal is to examine the efficacy of GLP-1 administered to control blood glucose in critically ill patients.
Detailed description
All patients whom on admission to the ICU (surgical, burn, & cardiac) who are expected to receive intensive insulin therapy for at least 72 hours are eligible to be enrolled. Once enrolled, the patients will be randomized to one of two groups: the experimental (intravenous GLP-1 infusion for 72 hours) or control groups (intravenous 0.9% sodium chloride (NaCl) infusion for 72 hours) in a double masked fashion. While enrolled, all patients will receive standard-of-care insulin therapy. Both groups will be maintained on the standard ICU specific protocol for glucose control.
Interventions
5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
DRUGSaline
5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
Sponsors
Society of Critical Care Medicine
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Men and women age \> 21 to 75 years of age. * All subjects who meet ICU specific criteria for inclusion in their glucose protocol and placed on insulin infusion protocol as standard of care. * Able to obtain patient or proxy consent.
Exclusion criteria
* Current diagnosis of malignancy. * Type 1 diabetes. * Inability to obtain informed consent. * On any Phase 1 trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Compare the Composite Overall Amount of Insulin Used With GLP-1 vs. Placebo to Reach and Maintain the ICU-specific Target Glucose Range. | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Compare the Number of Hypoglycemic Events Between GLP-1/Placebo Treatment | 2 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GLP-1 Glucagon-Like Peptide-1: 5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours. | 11 |
| Saline Saline: 5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours. | 8 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | P.I, Left institution. Study terminated | 11 | 8 |
Baseline characteristics
| Characteristic | GLP-1 | Saline | Total |
|---|---|---|---|
| Age, Customized >=21 and <=75 | 11 participants | 8 participants | 19 participants |
| Region of Enrollment United States | 11 participants | 8 participants | 19 participants |
| Sex: Female, Male Female | 1 Participants | 5 Participants | 6 Participants |
| Sex: Female, Male Male | 10 Participants | 3 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
To Compare the Composite Overall Amount of Insulin Used With GLP-1 vs. Placebo to Reach and Maintain the ICU-specific Target Glucose Range.
Time frame: 2 years
Population: The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Outcome measure data, if collected, is unknown since no data are available.
Secondary
Compare the Number of Hypoglycemic Events Between GLP-1/Placebo Treatment
Time frame: 2 years
Population: The PI left the institution and this study was terminated due to noncompliance with our Institutional Review Board. Outcome measure data, if collected, is unknown since no data are available.