CABG
Conditions
Keywords
CABG, Cardiac Surgical Patient
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.
Interventions
DRUGPlacebo
1.5 pmol/kg/min (5 ng/kg/min) saline infused continuously over 72 hours.
1.5 pmol/kg/min (5 ng/kg/min) GLP-1 infused continuously over 72 hours.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left Ventricular Systolic Function: Pulmonary Capillary Wedge Pressure | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Insulin Infusion Requirements | 72 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants GLP-1 (7-36) amide
GLP-1 (7-36) amide: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study was terminated,PI left institution | 12 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Customized Age, years (18-75) | 12 participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Left Ventricular Systolic Function: Pulmonary Capillary Wedge Pressure
Time frame: 2 years
Population: The raw study data is not available for this study. The study was terminated early due to the P.I.'s noncompliance with Johns Hopkins University School of Medicine Institutional Review Board Protocol and he has since left the institution. Significant efforts have been made to locate data, but it is unfortunately unavailable.
Secondary
Insulin Infusion Requirements
Time frame: 72 hours
Population: The raw study data is not available for this study. The study was terminated early due to the P.I.'s noncompliance with JHU IRB Protocol and he has since left the institution. Significant efforts have been made to locate data, but it is unfortunately unavailable.