Clinical trial NCT06057532: Carbohydrate Ingestion Prior to Surgery (CIPS)
Official title: Impact of Carbohydrate Ingestion Prior to Urologic Surgery to Improve Patient Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Urologic Surgical Procedures
Carbohydrate Loading
Preoperative Care
Keywords: Urologic Surgery
Preoperative Care
Carbohydrate Loading
Continuous glucose monitor
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare perioperative glycemic variability between study arms
timeFrame: From up to 5 days before surgery to up to 4 days after surgery.
measure: Compare perioperative clinical outcomes after surgery between study arms
timeFrame: From surgery to 90 days after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Health System
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jill M Hamilton-Reeves, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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