CArbohydrate Loading in Aortic Surgery

July 28, 2025 updated by: Igor Koncar, University of Belgrade

Preoperative Oral Carbohydrate Loading in Aortic Surgery

The adverse effects of overnight fasting before surgery have been well-documented in the contemporary literature. Still, due to the possibility of pulmonary aspiration of gastric contents, many clinicians worldwide still employ this practice. On the other hand, the benefits of preoperative oral carbohydrate loading (OCHL) have been shown in various patient groups. Studies examining the usefulness of preoperative OCHL in aortic surgery are lacking. In particular, no randomized control trials have specifically examined the impact of preoperative OCHL on the postoperative course in patients undergoing open abdominal aortic surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aims of the study are: 1) to assess the effect of preoperative OCHL on the postoperative course in terms of length of ICU stay, the incidence of surgical and non-surgical complications, postoperative local wound infections, and short-term (30-days) mortality rate; 2) to evaluate the impact of preoperative OCHL on glucose homeostasis, insulin resistance, and patients' subjective well-being; 3) to compare the differences between preoperative OCHL and a conventional fasting protocol.

A prospective, single-center randomized control trial will include approximately 50 consecutive patients undergoing elective open repair due to abdominal aortic aneurysm or Leriche Syndrome. All patients will be operated on under the conditions of general anesthesia during the period from April to October 2024 at the investigators' Institution.

Basic demographic, anthropometric, and clinical data of interest (data on current disease, comorbidities, smoking status, preoperative chronic therapy, previous operations, and basic laboratory and coagulation parameters) will be collected through patient interviews and obtained from medical records. Data regarding intraoperative and postoperative course (including length of ICU stay, postoperative complications, and intrahospital mortality) will be extracted from medical records and database included in daily practice. Data regarding short-term (30 days) morbidity and mortality will be obtained through telephone interviews or personally - on the postoperative control examinations.

Glucose and insulin values will be assessed from the peripheral venous or arterial blood samples (from the arterial cannula postoperatively), taken at T1, 9-11 p.m. in the evening before the surgery (before high-carbohydrate beverage in OCHL group), T2 90 min after high-carbohydrate beverage ingestion in OCHL group, i.e., at 06 a.m. in the control group, on the day of the surgery, T3 six hours following the surgery, and T4 06 a.m. on the first postoperative day. Other parameters of insulin resistance (Homeostatic Model Assessment for Insulin Resistance, HOMA-IR; insulin sensitivity index, HOMA-ISI; and homeostasis model assessment of β-cell function, HOMA-β) will be calculated based on the following equations: HOMA-IR = [fasting insulin (μU/mL) × fasting glucose (mmol/L)]/22.5; HOMA-ISI = 1/log/[fasting glucose (mmol/L) + fasting insulin (μU/mL)], HOMA-β = (20 × fasting plasma insulin [µU/ml])/(fasting plasma glucose [mmol/L] - 3.5), for each of four-time points. No intravenous fluid administration will be given preoperatively, while intraoperatively, no glucose-containing fluids nor insulin will be administered. Also, patients will not receive intravenous or oral glucose solutions six hours before the postoperative morning blood sampling (from midnight to 06 h). Subjective well-being will be assessed using the visual analog scale (VAS) for the six following aspects: anxiety, hunger, thirst, tiredness, pain, and headache. The patients will be instructed to mark a vertical line on a 100 mm horizontal scale, which will be marked with "no symptom" at its left end (score of zero) and with "the worst possible symptom" (score of 10) at its right end. The distance from the left end to the patient's mark will represent the score of the perceived symptom. The variables of subjective well-being will be evaluated at several time points: in the morning before the surgery, 6-12 hours after the surgery, and 24 hours after the surgery. Local wound infection will be defined as redness, pain, and/or drainage on the surgical site, along with an increase in infectious parameters, with or without fever > 38°C.

A median stay of three days with a standard deviation of one day was noted by analyzing the ICU length of stay in a historical cohort of patients who underwent open elective aortic surgery. A power calculation showed that a total sample size of 32 patients is sufficient to have an 80% chance of detecting, as significant at the 5% level, a decrease in the ICU length of stay from 3 in the control group to 2 days in the experimental group. To allow for dropout, the investigators will recruit 50 patients.

Study Type

Interventional

Enrollment (Actual)

40

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 Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • Clinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia

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:

  • Consecutive patients admitted due to elective surgical treatment of abdominal aortic aneurism or Leriche Syndrome.
  • Patients scheduled to be operated on first on a given day, that is, patients whose surgery will be performed first in the morning.
  • Personally signed informed consent.

Exclusion Criteria:

  • Patients with diabetes or fasting glucose level above seven mmol/L;
  • Patients with disorders that prolong gastric emptying (gastroesophageal reflux disease, history of gastrointestinal surgery, hiatus hernia or intestinal obstruction);
  • Patients with conditions that could potentially prolong the postoperative recovery (severe physical disability, cognitive impairment, autoimmune diseases, severe infection, significant liver and renal failure, or severe psychiatric/mental disorders);
  • Patients with alcohol/drug abuse
  • Obese patients with obesity class 3 (BMI ≥ 40 kg/m2);
  • Patients undergoing emergent surgery;
  • Patients treated with immunosuppressants and/or steroids in the past three months before surgery;
  • Patients in whom difficult airway is anticipated.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OCHL group

Approximately 25 patients will receive a high-carbohydrate beverage in the evening before surgery and two hours before the induction of anesthesia.

Intervention: carbohydrate-rich beverage

Glucose and insulin values will be assessed from the peripheral venous or arterial blood samples (from the arterial cannula postoperatively), taken at four-time points. Other parameters of insulin resistance (HOMA-IR, HOMA-ISI, and HOMA-β) will be calculated based on the values of fasting insulin and fasting glucose for each of four time points.

The subjective well-being variables will be evaluated in the morning before the surgery, 6-12 hours after the surgery, and 24 hours after the surgery.
Dietary supplement: carbohydrate-rich beverage
Patients in the OCHL group will drink a high-carbohydrate beverage (12.6% carbohydrates, 50 kcal/100 mL, 285 mOsm/kg; PreOp®, Nutricia, Zoetermeer, The Netherlands) 800 mL in the evening before surgery (between 9 p.m. and 11 p.m.), and 400 mL two hours before the induction of anesthesia.
Other Names:
  • the experimental group
No Intervention: Control group

Approximately 25 patients in the no-intervention (control) group will be fasted from midnight until surgery.

Glucose and insulin values will be assessed from the peripheral venous or arterial blood samples (from the arterial cannula postoperatively), taken at four-time points. Other parameters of insulin resistance (HOMA-IR, HOMA-ISI, and HOMA-β) will be calculated based on the values of fasting insulin and fasting glucose for each of four time points.

The subjective well-being variables will be evaluated in the morning before the surgery, 6-12 hours after the surgery, and 24 hours after the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The ICU length of stay
Time Frame: up to 10 days following surgery
The ICU length of stay will be defined as the interval from the end of surgery to the date of ICU discharge.
up to 10 days following surgery
Six aspects of subjective well-being according to the visual analog scale
Time Frame: preoperatively - 1 day following surgery
The variables of the subjective well-being will be evaluated in several time points: in the morning before the surgery, 6-12h following the surgery and 24h following the surgery. The minimum score is zero, and the maximum score is 10. The higher the score, the worse the outcome.
preoperatively - 1 day following surgery
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time Frame: 1 day preoperatively - 1 day following surgery
Values of glucose and serum insulin will be assessed at four time-points: T1, 9-11 p.m. in the evening before the surgery (before high-carbohydrate beverage in OCHL group); T2 90 min after high-carbohydrate beverage ingestion in OCHL group, i.e., at 06 a.m. in the control group, on the day of the surgery; T3 6 h following the surgery, and T4 06 a.m. on the postoperative day 1. Values of HOMA-IR will be subsequently calculated for each of the four time points.
1 day preoperatively - 1 day following surgery
Insulin sensitivity index (HOMA-ISI)
Time Frame: 1 day preoperatively - 1 day following surgery
Values of glucose and serum insulin will be assessed at four time-points: T1, 9-11 p.m. in the evening before the surgery (before high-carbohydrate beverage in OCHL group); T2 90 min after high-carbohydrate beverage ingestion in OCHL group, i.e. at 06 a.m. in the control group, on the day of the surgery; T3 6 h following the surgery, and T4 06 a.m. on the postoperative day 1. Values of HOMA-ISI will be subsequently calculated for each of the four time points.
1 day preoperatively - 1 day following surgery
Homeostasis model assessment of β-cell function (HOMA-β)
Time Frame: 1 day preoperatively - 1 day following surgery
Values of glucose and serum insulin will be assessed at four time-points: T1, 9-11 p.m. in the evening before the surgery (before high-carbohydrate beverage in OCHL group); T2 90 min after high-carbohydrate beverage ingestion in OCHL group, i.e. at 06 a.m. in the control group, on the day of the surgery; T3 6 h following the surgery, and T4 06 a.m. on the postoperative day 1. Values of HOMA-β will be subsequently calculated for each of the four time points.
1 day preoperatively - 1 day following surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: From the date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to two months following surgery.
Length of hospital stay will be defined as the interval from the admission to the hospital to the date of hospital discharge.
From the date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to two months following surgery.
30-day mortality rate
Time Frame: 30 days following surgery
30-day mortality would refer to any lethal outcome (due to any cause), that would occur 30 days following surgery.
30 days following surgery
The incidence of local wound infections
Time Frame: 30 days following surgery
Local wound infection will be defined as redness, pain and/or drainage on the surgical site, along with an increase in infectious parameters, with or without fever > 38°C.
30 days following surgery
The incidence of postoperative surgical complications
Time Frame: 30 days following surgery
Postoperative surgical complications will be defined as complications related to the surgical procedure within 30 days after the operation.
30 days following surgery
The incidence of postoperative non-surgical complications
Time Frame: 30 days following surgery
Postoperative non-surgical complications will be defined as complications which are not related to surgical procedures/techniques.
30 days following surgery

Collaborators and Investigators

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

Sponsor

University of Belgrade

Investigators

  • Study Chair: Slobodan Cvetkovic, MD, Ph.D., Clinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia

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 (Actual)

August 1, 2024

Primary Completion (Actual)

February 1, 2025

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

March 23, 2024

First Submitted That Met QC Criteria

March 29, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALAS

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

product manufactured in and exported from the U.S.

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.

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