Prevention and Treatment of Common Hyperglycemia in Surgery Pilot (NCT06624956) | Clinical Trial Compass
CompletedPhase 4
Prevention and Treatment of Common Hyperglycemia in Surgery Pilot
United States106 participantsStarted 2024-09-04
Plain-language summary
The PATCH pilot trial aims to establish feasibility and determine the sample size of a future, large-scale, multi-site RCT, as well as reinforce the long-standing known safety profile of glucose, insulin, and potassium (GIK) and explore the physiologic response. We hypothesize that the use of GIK in non-diabetic patients undergoing abdominal surgery, will reduce rates of morbidity \& death compared to standard of care treatment. In brief, primary outcomes of interest include estimation of the standard deviation (to derive a sample size estimation) and the ability to recruit target population, assessment of patient compliance/burden, and assessment of provider compliance/burden (feasibility).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adults 18 years of age or older
✓. Patients undergoing abdominal surgery planned to last greater than 4 hours with inpatient admission
✓. Patients at UWMC - Montlake
Exclusion criteria
✕. Known diagnosis of diabetes or altered glucose homeostasis during preoperative evaluation (single fasting blood sugar≥126 mg/dL or HbA1C≥6.5 percent).
✕. Known diagnosis of chronic kidney disease (moderate-to-severe, or worse)
✕. Patients receiving chronic systemic steroids.
✕. Patients undergoing cardiac or solid organ transplant procedures.