Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00966654
Other study ID # NA_00013802
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received August 26, 2009
Last updated March 25, 2010
Start date September 2008
Est. completion date September 2012

Study information

Verified date March 2010
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 48
Est. completion date September 2012
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours.
GLP-1 (7-36) amide
1.5 pmol/kg/min (5 ng/kg/min) saline or GLP-1 infused continuously over 72 hours.

Locations

Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Left ventricular systolic function, Left ventricular diastolic function and Hemodynamic parameters when available: PCWP, CO, SVR, HR, MAP 2 years No
Secondary Insulin infusion requirements, Frequency of hypoglycemic events, Length of stay in ICU setting and Inotropic requirements at each 12 hour period after arrival to the ICU and during infusion 72 hours No
See also
  Status Clinical Trial Phase
Completed NCT01956708 - Transfer of Cardioprotection During RIPC N/A
Completed NCT01928745 - Experimental Determination of Atot en Ka in the Critically Ill N/A
Completed NCT00524901 - Study of the Use of a Single Dose of Erythropoietin to Treat Acute Myocardial Ischemia Phase 2
Completed NCT01282671 - Effects of Deep Breathing Exercises Two Months After Cardiac Surgery Phase 2
Completed NCT03050489 - Assessment of Myocardial Ischemic-Reperfusion Injury During Off- and On- Pump CABG
Recruiting NCT06124937 - Empagliflozin to Prevent Post-Operative Atrial Fibrillation Phase 3
Completed NCT00269243 - Management With Accupril Post Bypass Graft Phase 4
Recruiting NCT03139929 - Measurement of MSFP and Stressed Volume With CardioQ+®
Active, not recruiting NCT03424941 - The TransCatheter Valve and Vessels Trial N/A
Completed NCT06317363 - Effects of Acapella VS CHEST Physiotherapy in Post-Operative CABG Patients N/A
Completed NCT05023083 - Cross Cultural Adaptation of Functional Status Questionnaire in Urdu Language in CABG Patients
Completed NCT03800264 - Bisoprolol Versus Corticosteroid and Bisoprolol Combination for Prophylaxis Against Atrial Fibrillation After on Pump Coronary Artery Bypass Surgery Phase 4
Completed NCT05285865 - Scapular Mobilization on Inspiratory Capacity of Post-CABG Patients N/A
Not yet recruiting NCT06173609 - Long LIMA Patch on Left Anterior Descending Coronary Artery in CABG
Not yet recruiting NCT06238011 - Dexmedetomidine vs Control on Attenuation Hemodynamic Response to Noxious Stimuli in CABG Surgical Patients N/A
Active, not recruiting NCT06127147 - High-intensity Inspiratory Muscle Training as a Pre-cardiac Rehabilitation in Heart Disease N/A
Recruiting NCT06029556 - Effects of Early Mobility Protocols in Cardiac ICU N/A
Enrolling by invitation NCT01205620 - IRB-HSR# 15084 A Prospective, Unblinded, Controlled Study to Evaluate the Effect of the ITPR in Patients Undergoing OPCAB Surgery Phase 2