Title
The Efficacy of Glucagon Like Peptide (GLP) - 1(7-36) Amide for Glycemic Control in Critically Ill Patients
The Efficacy of GLP - 1 (7-36) Amide for Glycemic Control in Critically Ill Surgical Patients
Phase
Phase 2Lead Sponsor
Johns Hopkins UniversityStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Critically Ill HypoglycemiaIntervention/Treatment
glucagon-like peptide-1 sodium chloride ...Study Participants
19The goal of this present proposal is to examine the efficacy of GLP-1 administered to control blood glucose in critically ill patients.
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.
5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
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.
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