Carbohydrate Ingestion Prior to Surgery (CIPS)

Purpose

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.

Conditions

  • Urologic Surgical Procedures
  • Carbohydrate Loading
  • Preoperative Care

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention 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.
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Study drink powders will be measured and assigned a code by study staff that will not dispense the study drink powders to participants.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
UCAN SuperStarch study drinks
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
    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.
Active Comparator
Gatorade study drinks
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
    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.

Recruiting Locations

University of Kansas Health System
Kansas City, Kansas 66160
Contact:
Clinical Research Coordinator
913-945-5037
mbechtel2@kumc.edu

More Details

Status
Recruiting
Sponsor
University of Kansas Medical Center

Study Contact

Misty D Bechtel
913-945-5037
mbechtel2@kumc.edu

Detailed Description

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.