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OpenTrials
Active, Not Recruiting

NCT Number: NCT06057532

Carbohydrate Ingestion Prior to Surgery (CIPS)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Health System

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UCAN SuperStarch

Dietary Supplement

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.

Gatorade

Dietary Supplement

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.

Primary outcomes

  1. Compare perioperative glycemic variability between study arms

    Time frame: From up to 5 days before surgery to up to 4 days after surgery.

    Differences in blood glucose, insulin, free fatty acids will be compared

  2. Compare perioperative clinical outcomes after surgery between study arms

    Time frame: From surgery to 90 days after surgery.

    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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Acronym: CIPS

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 28, 2023
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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