Carbohydrate Ingestion Prior to Surgery (CIPS)

Study Overview
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Brief Summary
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The objective is to determine the impact of taking a specialized form of carbohydrate in the immediate preoperative period on metabolic markers, surgical outcomes and patient health. Patients will be randomized to receive a specialized sports drink or a standard sports drink. Patients will have a continuous glucose monitor (CGM) placed on their upper arm to measure glucose throughout surgery and during the post-operative period.

Detailed Description
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About 50 million major surgeries are performed annually in the United States. Longer duration surgeries increase metabolic demand and impose a greater risk of infections and worse outcomes than shorter duration surgeries. The release of hormones and catecholamines from surgery dampens the body's response to insulin which leads to acute insulin resistance. Even though the insulin resistance eventually resolves within weeks of surgery, metabolic stress during that window of time makes patients susceptible to infection and tissue catabolism. Therefore, there is a critical need to improve perioperative management of high-risk patients to decrease complications associated with major surgery which remains a significant cause of morbidity and mortality in these patients. Up to 40% of patients undergoing major operations experience perioperative hyperglycemia (>140 mg/dL). Perioperative hyperglycemia has been implicated in increasing risk of perioperative complications including surgical site infection, reoperation, and mortality. With 50 million surgeries performed each year, preoperative optimization is essential for favorable postsurgical outcomes. A long-held dogma of prolonged fasting prior to the administration of anesthesia has slowed the adoption of consumption of carbohydrate drinks before surgery despite data showing a lower surgical stress response and decreased insulin resistance along with improved patient satisfaction. Multidisciplinary consensus has been necessary to implement change. The Enhanced Recovery after Surgery (ERAS) Society has shifted practice to optimize multidisciplinary perioperative care and one main tenet includes preoperative carbohydrate loading. While the dose and type vary across institutions and practices, the American Society of Enhanced Recovery/Perioperative Quality Initiative joint consensus statement and the American Society of Anesthesiologists recommend consumption of a preoperative beverage containing ≥50 g of carbohydrate (CHO) for surgical patients 2-3 hours prior to surgery. Despite this recommendation, the practice of preoperative oral intake has still lagged with only 20% adherence in surgical care pathways.

Official Title
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Impact of Carbohydrate Ingestion Prior to Urologic Surgery to Improve Patient Outcomes

Conditions
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Urologic Surgical Procedures, Carbohydrate Loading, Preoperative Care

Intervention / Treatment
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* Dietary Supplement: UCAN SuperStarch
* Dietary Supplement: Gatorade


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults, at least 18 years old, undergoing major urologic surgery (proposed duration more than 4 hours), must be able to swallow liquid, must speak English. Exclusion Criteria: diagnosis of Type 1 or 2 diabetes mellitus A1C of 6.5% or higher pregnant or lactating known allergy to milk, soy, egg, wheat, peanuts, tree nut, swallowing difficulties

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a randomized, double-blinded, clinical trial that will provide a starch or standard sports drink at least 2 hours before surgery to evaluate perioperative glycemic variability. Patients will be randomized and have a 50/50 chance of getting one of the two drinks being studied.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UCAN SuperStarch study drinks<br>Intervention group will receive UCAN SuperStarch study drinks. 100g carbohydrate will be consumed the night before surgery and 50g carbohydrate will be consumed 2 - 3 hours before surgery. | Dietary Supplement: UCAN SuperStarch<br>* Intervention patients will have a continuous glucose monitor placed on their upper arm by the study team 1 - 5 days prior to surgery. These patients will drink the intervention study drink and record information about how they feel before and after consumption.<br>|
| Active Comparator: Gatorade study drinks<br>Active Control group will receive Gatorade study drinks. 100g carbohydrate will be consumed the night before surgery and 50g carbohydrate will be consumed 2 - 3 hours before surgery. | Dietary Supplement: Gatorade<br>* Active control patients will have a continuous glucose monitor placed on their upper arm by the study team 1 - 5 days prior to surgery. These patients will drink the active control study drink and record information about how they feel before and after consumption.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare perioperative glycemic variability between study arms | Differences in blood glucose, insulin, free fatty acids will be compared | From up to 5 days before surgery to up to 4 days after surgery. | 
| Compare perioperative clinical outcomes after surgery between study arms | Differences in post-operative complications within 30 days after surgery, length of hospital stay, post-operative infections, and number of patients needing intraoperative or postoperative insulin treatment will be be compared between study arms. | From surgery to 90 days after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urologic Surgery, Preoperative Care, Carbohydrate Loading, Continuous glucose monitor