Carbohydrate Ingestion Prior to Surgery (CIPS) (CIPS)

September 26, 2023 updated by: Jill Hamilton-Reeves, PhD RD LD, University of Kansas Medical Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From up to 5 days before surgery to up to 4 days after surgery.
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.
From surgery to 90 days after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Jill M Hamilton-Reeves, PhD, University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00150605

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preoperative Care

Clinical Trials on UCAN SuperStarch

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe