Effect of GLP - 1 (7-36 Amide) on Myocardial Function Following Coronary Artery Bypass (CABG) Surgery

NCT ID: NCT00966654

Last Updated: 2017-07-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2012-09-30

Brief Summary

This research is being done to see if giving a hormone called GLP-1 can improve heart function and reduce length of stay in the Cardiac Surgical Intensive Care Unit (CSICU) in people who have non-emergent coronary artery bypass graft (CABG) surgery.

Detailed Description

After CABG surgery, a condition known as hyperglycemia or high blood sugar often occurs even in patients who have never been diagnosed with diabetes. This high blood sugar can lead to complications after surgery such as infections at the site of the incision. Additionally, if there is any cardiac muscle injury either prior to or during surgery, the injured cardiac muscle can not use glucose (the body's fuel and energy source) as well as it did prior to the injury. This reduced ability to use glucose slows the cardiac muscles ability to repair itself and provide the normal pumping force and function needed to circulate the blood throughout the body. This inability to repair itself and/or provide the normal pumping force and function can make it difficult for the patient as well as increase the length of stay required in the CSICU.

GLP-1 has the ability to lower blood sugar and help cells use glucose for fuel and energy but when the blood sugar becomes low its glucose lowering ability decreases. In this study, we want to see we want to see if GLP-1 may help keep the blood sugar within normal limits and reduce or eliminate the need for insulin. We will also see whether it will help the heart recover more quickly.

Conditions

CABG

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Saline

Saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1.5 pmol/kg/min (5 ng/kg/min) saline infused continuously over 72 hours.

GLP-1

GLP-1 (7-36) amide

Group Type: ACTIVE_COMPARATOR

GLP-1 (7-36) amide

Intervention Type: DRUG

1.5 pmol/kg/min (5 ng/kg/min) GLP-1 infused continuously over 72 hours.

Interventions

Placebo

1.5 pmol/kg/min (5 ng/kg/min) saline infused continuously over 72 hours.

Intervention Type: DRUG

GLP-1 (7-36) amide

1.5 pmol/kg/min (5 ng/kg/min) GLP-1 infused continuously over 72 hours.

Intervention Type: DRUG

Other Intervention Names

Saline; GLP-1

Eligibility Criteria

Inclusion Criteria

• Males and Females age > 18 years of age
• Able to consent
• Scheduled for non-emergent coronary artery bypass graft (CABG)
• Have an ejection fraction < 35%
• Ischemic patients with Left Ventricular Dysfunction (LVD) who need a valve procedure with their CABG

Exclusion Criteria

• Emergency coronary artery bypass graft surgery
• Patients with an ejection fraction > 35%
• Repeat or redo CABG patients
• Patients with a history of pancreatitis
• Pregnant or lactating females

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dariush Elahi, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00013802

Identifier Type: -

Identifier Source: org_study_id