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PI left JHU
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline | Placebo Comparator | Saline |
|
| GLP-1 | Active Comparator | GLP-1 (7-36) amide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 1.5 pmol/kg/min (5 ng/kg/min) saline infused continuously over 72 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Systolic Function: Pulmonary Capillary Wedge Pressure | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Infusion Requirements | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dariush Elahi, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | GLP-1 | 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. OR Placebo (saline) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Although 12 participants were enrolled in this study, their assignment to study arm/group, if any, is unknown. The P.I. has left the institution and neither he, nor further data (if any), are available.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Left Ventricular Systolic Function: Pulmonary Capillary Wedge Pressure | 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. | Posted | 2 years |
|
This study was terminated prematurely due to the PI leaving the institution. The time frame for the Adverse Events (if collected) is unknown since no data is available.
This study was terminated prematurely due to the PI leaving the institution. The data for the Adverse Events (if collected) is unknown since no data is available.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GLP-1 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johns Hopkins University Clinical Trials Program | Johns Hopkins University School of Medicine | 410-550-6484 | registerclinicaltrials@jhmi.edu |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| C055453 | glucagon-like peptide 1 (7-36)amide |
| D052216 | Glucagon-Like Peptide 1 |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| GLP-1 (7-36) amide | Drug | 1.5 pmol/kg/min (5 ng/kg/min) GLP-1 infused continuously over 72 hours. |
|
|
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Insulin Infusion Requirements | 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. | Posted | 72 hours |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Saline | Saline Placebo: 1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours. | 0 | 0 | 0 | 0 |
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| D017670 |
| Sodium Compounds |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |