Status:
TERMINATED
Perioperative Stress Hyperglycemia in General and Vascular Surgery Patients
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Hyperglycemia Stress
Eligibility:
All Genders
45-80 years
Phase:
PHASE4
Brief Summary
Hyperglycemia is seen in approximately 30% of patients who do not have a history of diabetes and undergo general surgery. Hyperglycemia in this setting is associated with increased risk of postoperati...
Detailed Description
Stress hyperglycemia (SH), defined as a blood glucose \>140 mg/dl in hospitalized patients without a prior history of diabetes mellitus (DM) is associated with increased risk of complications and mort...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Men and women without known history of diabetes with ages between 45 and 80 years undergoing non-cardiac general or vascular surgery
- BMI ≥30 kg/m2 and pre-DM or DM by OGTT or HbA1c
- Exclusion criteria:
- Patients prescribed or taking antihyperglycemic medications
- Patients undergoing cardiac surgery or patients anticipated to require ICU care
- Patients expected to be admitted less than 48-72 hours after surgery
- Severely impaired renal function (eGFR \< 30 mL/min) or clinically significant hepatic failure
- Treatment with oral (equivalent to prednisone \> 5 mg/day) or injectable corticosteroids
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study; unable to consent
- Pregnant or breast feeding at time of enrollment
- Prisoners
- Patients undergoing gastrointestinal surgery or at high risk for gastrointestinal obstruction/ileus or expected to require gastrointestinal suction
- Patients with delayed gastric emptying, pancreatic or gallbladder disease
- Patients with personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 (MEN2)
Exclusion
Key Trial Info
Start Date :
August 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04862234
Start Date
August 6 2021
End Date
June 22 2023
Last Update
January 17 2025
Active Locations (2)
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1
Emory University Hospital
Atlanta, Georgia, United States, 30322
2
Grady Hospital
Atlanta, Georgia, United States, 30322