- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03743025
Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stress hyperglycemia is common in the perioperative period and is associated with increased risk of death postoperatively. Counterregulatory hormones and inflammatory mediators appear to modulate the acute biological response to stress, however, the pathophysiological pathways that result in stress hyperglycemia and its link to poor clinical outcomes are not well understood. At least half of non-diabetes mellitus (DM) patients undergoing cardiac surgery develop stress hyperglycemia shown to be an independent risk factor of morbidity and mortality. The current approach to treat hyperglycemia with insulin has major limitations including high resource utilization and high risk of hypoglycemia. The main goals of this study are to examine baseline and postoperative metabolic profiles of non-diabetic, coronary artery bypass grafting (CABG) patients with stress hyperglycemia and to study the effect of a long-acting glucagon-like peptide-1 receptor agonists (GLP-1 RA) on the prevention of stress-hyperglycemia and modulation of metabolic stress during cardiac surgery.
To examine whether exposure to dulaglutide, a GLP-1 RA, can improve glycemic control and ameliorate the inflammatory response to acute surgical stress obese patients without diabetes mellitus undergoing CABG surgery.will be randomized to receive either dulaglutide or placebo two to three days prior to surgery. The study ultimately wants to provide evidence to support the use of novel therapies to prevent and manage stress hyperglycemia in the inpatient setting.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Francisco Pasquel, MD, MPH
- Phone Number: 404-7781695
- Email: fpasque@emory.edu
Study Contact Backup
- Name: Mireya Perez-Guzman, MD
- Email: mireya.citlalli.perez-guzman@emory.edu
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital
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Atlanta, Georgia, United States, 30303
- Grady Memorial Hospital
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Atlanta, Georgia, United States, 30308
- Emory Hospital Midtown
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Males or females between the ages of 40 and 80 years
- Body mass index (BMI) ≥25
- Undergoing elective CABG surgery
- No previous history of diabetes or hyperglycemia
Exclusion Criteria:
- Hyperglycemia (BG>125 mg/dl or HbA1c > 6.5%) or previous treatment with antidiabetic agents
- Impaired renal function (GFR < 30 ml/min) or clinically significant hepatic failure
- Gastrointestinal obstruction expected to require gastrointestinal suction
- Patients with clinically relevant pancreatic or gallbladder disease
- Treatment with oral or injectable corticosteroid
- Mental condition rendering the subject unable to understand the possible consequences of the study
- Pregnancy or breastfeeding at time of enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dulaglutide Arm
Participants without a history of DM who are randomized to receive a single injection of dulaglutide (0.75 mg/0.5 mL solution in a single-dose pen) one to three days prior to surgery.
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Participants randomized at pre-surgery/anesthesia visit and without a history of DM will receive a single injection of Dulaglutide injection: 0.75 mg/0.5 mL solution in a single-dose pen 1 to 3 days prior to surgery
Other Names:
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Placebo Comparator: Placebo Arm
Participants without a history of DM who are randomized to receive a single injection of a placebo (saline injection of 0.5 mL pre-drawn solution) one to three days prior to surgery.
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Participants randomized at pre-surgery/anesthesia visit and without a history of DM will receive a single injection of Saline injection/0.5 mL pre-drawn solution 1 to 3 days prior to surgery
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of Blood Glucose levels (BG) > 140 mg/dl During Post Operative Period
Time Frame: Up to 7 days postoperatively
|
Stress-hyperglycemia is defined as any post-CABG hospital-obtained blood glucose (BG) levels >140 mg/dl.
Information on BG measurements both at bedside by glucose meter and by hospital laboratory will be collected.
BG will be measured every 1-2 hour during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards.
To to determine if dulaglutide can prevent stress-hyperglycemia, the number of BG levels > 140 mg/dl during the post-operative period in patients randomized to dulaglutide or placebo study arms are recorded and compared.
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Up to 7 days postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean blood glucose levels in mg/dL during the Intensive Care Unit (ICU) stay post operatively
Time Frame: During the ICU stay (Up to 5 days postoperatively)
|
To measure glucose control the mean blood glucose levels in mg/dL during the Intensive Care Unit (ICU) stay post operatively are measured between patients randomized to dulaglutide or placebo arms.
Information on BG measurements both at bedside by glucose meter and by hospital laboratory will be collected.
BG will be measured every 1-2 hour during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards.
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During the ICU stay (Up to 5 days postoperatively)
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Number of Participants with Stress-hyperglycemia Requiring Rescue Therapy with Subcutaneous Insulin after Discontinuation of CII
Time Frame: During the hospital stay (Up to 7 days postoperatively)
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Patients with two consecutive BG >180 mg/dl, or average daily BG >180 mg/dl will be started on rescue therapy with subcutaneous basal insulin (glargine or levemir) once daily.
Information on BG measurements both at bedside by glucose meter and by hospital laboratory will be collected.
BG will be measured every 1-2 hour during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards.
The number of participants in need of rescue therapy with subcutaneous insulin post operatively between patients randomized to dulaglutide or placebo arms is recorded and compared.
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During the hospital stay (Up to 7 days postoperatively)
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Number of Participants Needing CII Treatment in the ICU
Time Frame: During the hospital stay (Up to 7 days postoperatively)
|
Patients with two consecutive BG >180 mg/dl, or average daily BG >180 mg/dl will be started on rescue therapy with subcutaneous basal insulin (glargine or levemir) once daily.
Information on BG measurements both at bedside by glucose meter and by hospital laboratory will be collected.
BG will be measured every 1-2 hour during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards.
The number of participants needing CII while in the ICU post operatively between patients randomized to dulaglutide or placebo arms is recorded and compared.
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During the hospital stay (Up to 7 days postoperatively)
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Mean blood glucose levels in mg/dL during the hospital stay
Time Frame: During the hospital stay (Up to 7 days postoperatively)
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To measure glucose control the mean blood glucose levels in mg/dL during the non-ICU hospital stay post-operatively are measured between patients randomized to dulaglutide or placebo arms.
Information on BG measurements both at bedside by glucose meter and by hospital laboratory will be collected.
BG will be measured every 1-2 hour during continuous insulin infusion (CII) in the ICU, and before meals and at bedtime after transition to regular wards.
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During the hospital stay (Up to 7 days postoperatively)
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Mean Units per Hours of Insulin While in the ICU
Time Frame: During the ICU stay (Up to 5 days postoperatively)
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The mean insulin dose during the time that participants are in the ICU is assessed as insulin infusions units per hour.
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During the ICU stay (Up to 5 days postoperatively)
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Mean Insulin Dose Per Day While in the ICU
Time Frame: During the ICU stay (Up to 5 days postoperatively)
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The mean insulin dose during the time that participants are in the ICU is assessed as insulin dose per day.
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During the ICU stay (Up to 5 days postoperatively)
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Duration of CII
Time Frame: During the hospital stay (Up to 7 days postoperatively)
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The duration of continuous insulin infusion (CII) is assessed in hours.
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During the hospital stay (Up to 7 days postoperatively)
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Days of Subcutaneous (SC) Insulin After Discontinuation of CII
Time Frame: During the hospital stay (Up to 7 days postoperatively)
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The number of days that subcutaneous (SC) is required after continuous insulin infusion (CII) is discontinued.
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During the hospital stay (Up to 7 days postoperatively)
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Amount of SC Insulin
Time Frame: During the hospital stay (Up to 7 days postoperatively)
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The amount of subcutaneous (SC) insulin required in ICU and non-ICU hospital stay.
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During the hospital stay (Up to 7 days postoperatively)
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Number of Hyperglycemic Events
Time Frame: During the hospital stay (Up to 7 days postoperatively)
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The number of hyperglycemic events, defined as BG > 200 mg/dl, during ICU and non-ICU hospital stay.
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During the hospital stay (Up to 7 days postoperatively)
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Number of Hypoglycemic Events
Time Frame: During the hospital stay (Up to 7 days postoperatively)
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The number of hypoglycemic events (<70, < 54, and <40 mg/dl) during ICU and non-ICU hospital stay.
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During the hospital stay (Up to 7 days postoperatively)
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Number of Mortality and Complications
Time Frame: During the hospital stay (Up to 7 days postoperatively)
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The number of participants experiencing a composite of mortality and complications.
Complications include sternal wound infection, bacteremia, pneumonia], acute kidney injury, and acute myocardial infarction.
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During the hospital stay (Up to 7 days postoperatively)
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Number of Gastrointestinal Adverse Events
Time Frame: During the hospital stay (Up to 7 days postoperatively)
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The number of gastrointestinal adverse events of nausea, vomiting, ileus, pancreatitis.
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During the hospital stay (Up to 7 days postoperatively)
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ICU Length of Stay
Time Frame: During the ICU stay (Up to 5 days postoperatively)
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The number of days in the ICU.
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During the ICU stay (Up to 5 days postoperatively)
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Hospital Length of Stay
Time Frame: During the hospital stay (Up to 7 days postoperatively)
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The number of days in the hospital.
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During the hospital stay (Up to 7 days postoperatively)
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Number of ICU Readmissions
Time Frame: During the hospital stay (Up to 7 days postoperatively)
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The number of readmissions to the ICU.
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During the hospital stay (Up to 7 days postoperatively)
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Number of Cerebrovascular Events
Time Frame: During the hospital stay (Up to 7 days postoperatively)
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The number of cerebrovascular events.
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During the hospital stay (Up to 7 days postoperatively)
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Mortality
Time Frame: During the hospital stay (Up to 7 days postoperatively)
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The number of participant deaths while in the ICU and hospital.
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During the hospital stay (Up to 7 days postoperatively)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Francisco Pasquel, MD, MPH, Emory University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00097963
- 1K23GM128221-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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