Clinical trial NCT03743025: Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients
Official title: Metabolic Phenotyping During Stress Hyperglycemia in Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Stress Hyperglycemia
Keywords: Coronary Artery Bypass Surgery (CABG)
Post Operative
Obesity
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2018-11-15
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective placebo controlled randomized study
Primary purpose: TREATMENT

Brief summary: This study is a prospective randomized study to examine the effects of exposure to dulaglutide on the prevention of stress-hyperglycemia and the metabolic inflammatory response in the perioperative period.

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 researchers of this study ultimately want to provide evidence to support the use of novel therapies to prevent and manage stress hyperglycemia in the inpatient setting.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Blood Glucose Levels (BG) > 140 mg/dl During Post Operative Period
timeFrame: During the hospital stay (up to 12 days postoperatively)
Secondary outcomes:
measure: Mean Blood Glucose Levels During the Intensive Care Unit (ICU) Stay Postoperatively
timeFrame: During the ICU stay (up to 7 days postoperatively)
measure: Number of Participants Needing CII Treatment in the ICU
timeFrame: During the ICU stay (up to 7 days postoperatively)
measure: Number of Participants With Stress-hyperglycemia Requiring Rescue Therapy With Subcutaneous Insulin After Discontinuation of CII
timeFrame: During the hospital stay (up to 12 days postoperatively)
measure: Mean Blood Glucose Levels During the Hospital Stay
timeFrame: During the hospital stay (up to 12 days postoperatively)
measure: Mean Units Per Hour of Insulin While in the ICU
timeFrame: During the ICU stay (up to 7 days postoperatively)
measure: Mean Insulin Dose Per Day While in the ICU
timeFrame: During the ICU stay (up to 7 days postoperatively)
measure: Duration of Continuous Insulin Infusion (CII)
timeFrame: During the hospital stay (up to 12 days postoperatively)
measure: Days of Subcutaneous (SC) Insulin After Discontinuation of CII
timeFrame: During the hospital stay (up to 12 days postoperatively)
measure: Amount of SC Insulin Administered
timeFrame: During the hospital stay (up to 12 days postoperatively)
measure: Number of Participants Experiencing Hyperglycemic Events
timeFrame: During the hospital stay (up to 12 days postoperatively)
measure: Number of Participants Experiencing Hypoglycemic Events
timeFrame: During the hospital stay (up to 12 days postoperatively)
measure: Number of Participants Experiencing Mortality and Complications
timeFrame: During the hospital stay (up to 12 days postoperatively)
measure: Number of Participants Experiencing Gastrointestinal Adverse Events
timeFrame: During the hospital stay (up to 12 days postoperatively)
measure: ICU Length of Stay
timeFrame: During the ICU stay (up to 7 days postoperatively)
measure: Hospital Length of Stay
timeFrame: During the hospital stay (up to 12 days postoperatively)
measure: Number of ICU Readmissions
timeFrame: During the hospital stay (up to 12 days postoperatively)
measure: Number of Cerebrovascular Events
timeFrame: During the hospital stay (up to 12 days postoperatively)
measure: Participant Mortality
timeFrame: During the hospital stay (up to 12 days postoperatively)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Francisco Pasquel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: