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Intravenous Exenatide in Coronary Intensive Care Unit (ICU) Patients

Information source: Saint Luke's Health System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hyperglycemia; Acute Coronary Syndromes; Myocardial Infarction

Intervention: Exenatide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Saint Luke's Health System

Official(s) and/or principal investigator(s):
Steven P Marso, MD, Principal Investigator, Affiliation: Mid America Heart Institute Saint Luke's Health System

Summary

The purpose of this study is to determine the efficacy of intravenous Exenatide therapy in hyperglycemic patients admitted to the coronary intensive care unit.

Clinical Details

Official title: Intensive Exenatide Therapy in Hyperglycemic Patients Admitted to the Coronary Intensive Care Unit

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Median Glucose Values From Steady State Through 48 Hours or Until Discharge.

Time to Steady State

Secondary outcome:

Rates of Hypoglycemia and Severe Hypoglycemia

Serious Adverse Events (Death, Non-fatal Myocardial Infarction, and Non-fatal Stroke Through 30 Days)

Detailed description: Diabetic patients with acute myocardial infarction (MI) have particularly poor outcomes. Clinical practice guidelines from the American College of Cardiology/American Heart Association for the treatment of patients with acute coronary syndromes call for treatment to achieve preprandial glucose <110 mg/dL, a maximum daily target <180 mg/dL, and a post-discharge hemoglobin A1c <7%. Initiation of aggressive insulin therapy is also warranted to achieve blood glucose <150 mg/dL during days 0-3 and 80-110 mg/dL when possible thereafter. To date, no studies have been conducted assessing the efficacy of intravenous exenatide administration on achieving glucose lowering in hyperglycemic coronary ICU patients.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Admission to coronary ICU

- Admission blood glucose 140-299 mg/dL

- Primary cardiovascular diagnosis by attending physician

- Under primary care of cardiology service

- Age > 18 years old

- Ventilator independent

- Able to provide informed consent

Exclusion Criteria:

- Admission blood glucose < 140 or > 300 mg/dL

- Ventilator dependent

- Unconscious sedation

- Type 1 diabetes

- Known pregnancy

- Admitted to coronary ICU for right heart cath to measure hemodynamics prior to

transplant

- Post transplant procedure

- Currently enrolled in another clinical trial

- Unable to provide informed consent

- Creatinine clearance < 30 mL/min

- On insulin treatment except for monotherapy with long-acting basal insulin (e. g.,

insulin glargine [LantusĀ®] or detemir [LevemirĀ®])

- Gastroparesis

Locations and Contacts

Mid America Heart Institute Saint Luke's Health System, Kansas City, Missouri 64111, United States
Additional Information

Starting date: August 2008
Last updated: November 19, 2014

Page last updated: August 23, 2015

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