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Carbohydrate Ingestion Prior to Surgery (CIPS) (CIPS)

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ClinicalTrials.gov Identifier: NCT06057532
Recruitment Status : Not yet recruiting
First Posted : September 28, 2023
Last Update Posted : September 28, 2023
Sponsor:
Information provided by (Responsible Party):
Jill Hamilton-Reeves, PhD RD LD, University of Kansas Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Urologic Surgical Procedures Carbohydrate Loading Preoperative Care Dietary Supplement: UCAN SuperStarch Dietary Supplement: Gatorade Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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.
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.
Primary Purpose: Prevention
Official Title: Impact of Carbohydrate Ingestion Prior to Urologic Surgery to Improve Patient Outcomes
Estimated Study Start Date : October 1, 2023
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : May 1, 2025
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06057532


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

Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Jill M Hamilton-Reeves, PhD University of Kansas Medical Center
More Information
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Publications:

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Responsible Party: Jill Hamilton-Reeves, PhD RD LD, Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT06057532    
Other Study ID Numbers: STUDY00150605
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jill Hamilton-Reeves, PhD RD LD, University of Kansas Medical Center:
Urologic Surgery
Preoperative Care
Carbohydrate Loading
Continuous glucose monitor