CArbohydrate Loading in Aortic Surgery

NCT06349382 | Completed DMC

• 1 other identifier: CALAS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abdominal Aortic Aneurysm; Leriche Syndrome

Outcome Measures

Primary Outcomes (5)

• The ICU length of stay

  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

• Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

  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)

  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)

  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

• Six aspects of subjective well-being according to the visual analog scale

  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

Secondary Outcomes (5)

• Length of hospital stay

  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

  30 days following surgery

• The incidence of local wound infections

  30 days following surgery

• The incidence of postoperative surgical complications

  30 days following surgery

• The incidence of postoperative non-surgical complications

  30 days following surgery

Study Arms (2)

OCHL group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

carbohydrate-rich beverage DIETARY_SUPPLEMENT

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.

Also known as: the experimental group

OCHL group

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

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

Belgrade, Serbia, 11000, Serbia

Location

Related Publications (11)

• Sun J, Wei G, Hu L, Liu C, Ding Z. Perioperative pulmonary aspiration and regurgitation without aspiration in adults: a retrospective observational study of 166,491 anesthesia records. Ann Palliat Med. 2021 Apr;10(4):4037-4046. doi: 10.21037/apm-20-2382. Epub 2021 Mar 23.

  PMID: 33832306 BACKGROUND

• Xu D, Zhu X, Xu Y, Zhang L. Shortened preoperative fasting for prevention of complications associated with laparoscopic cholecystectomy: a meta-analysis. J Int Med Res. 2017 Feb;45(1):22-37. doi: 10.1177/0300060516676411. Epub 2017 Jan 12.

  PMID: 28222625 BACKGROUND

• Zhou G, Zhu F, An Y, Qin L, Lv J, Zhao X, Shen J. Prolonged preoperative fasting and prognosis in critically ill gastrointestinal surgery patients. Asia Pac J Clin Nutr. 2020;29(1):41-47. doi: 10.6133/apjcn.202003_29(1).0006.

  PMID: 32229440 BACKGROUND

• Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.

  PMID: 21712716 BACKGROUND

• Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7.

  PMID: 28385477 BACKGROUND

• Joshi GP, Abdelmalak BB, Weigel WA, Harbell MW, Kuo CI, Soriano SG, Stricker PA, Tipton T, Grant MD, Marbella AM, Agarkar M, Blanck JF, Domino KB. 2023 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting: Carbohydrate-containing Clear Liquids with or without Protein, Chewing Gum, and Pediatric Fasting Duration-A Modular Update of the 2017 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting. Anesthesiology. 2023 Feb 1;138(2):132-151. doi: 10.1097/ALN.0000000000004381.

  PMID: 36629465 BACKGROUND

• Cheng PL, Loh EW, Chen JT, Tam KW. Effects of preoperative oral carbohydrate on postoperative discomfort in patients undergoing elective surgery: a meta-analysis of randomized controlled trials. Langenbecks Arch Surg. 2021 Jun;406(4):993-1005. doi: 10.1007/s00423-021-02110-2. Epub 2021 Feb 25.

  PMID: 33629128 BACKGROUND

• Rizvanovic N, Nesek Adam V, Causevic S, Dervisevic S, Delibegovic S. A randomised controlled study of preoperative oral carbohydrate loading versus fasting in patients undergoing colorectal surgery. Int J Colorectal Dis. 2019 Sep;34(9):1551-1561. doi: 10.1007/s00384-019-03349-4. Epub 2019 Jul 15.

  PMID: 31309323 BACKGROUND

• Liu B, Wang Y, Liu S, Zhao T, Zhao B, Jiang X, Ye L, Zhao L, Lv W, Zhang Y, Zheng T, Xue Y, Chen L, Chen L, Wu Y, Li Z, Yan J, Wang S, Sun X, Gao G, Qu Y, He S. A randomized controlled study of preoperative oral carbohydrate loading versus fasting in patients undergoing elective craniotomy. Clin Nutr. 2019 Oct;38(5):2106-2112. doi: 10.1016/j.clnu.2018.11.008. Epub 2018 Nov 17.

  PMID: 30497695 BACKGROUND

• Nygren J. The metabolic effects of fasting and surgery. Best Pract Res Clin Anaesthesiol. 2006 Sep;20(3):429-38. doi: 10.1016/j.bpa.2006.02.004.

  PMID: 17080694 BACKGROUND

• Nygren J, Thorell A, Jacobsson H, Larsson S, Schnell PO, Hylen L, Ljungqvist O. Preoperative gastric emptying. Effects of anxiety and oral carbohydrate administration. Ann Surg. 1995 Dec;222(6):728-34. doi: 10.1097/00000658-199512000-00006.

  PMID: 8526579 BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Leriche Syndrome

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Arterial Occlusive Diseases

Study Officials

• Slobodan Cvetkovic, MD, Ph.D.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vascular surgeon, MD, Ph.D.

Model Details: Participants will be randomized to receive preoperative OCHL (the experimental group) or no intervention (the control group) in a 1:1 ratio. Randomization will be performed using computer-generated randomization codes, which will be held in sealed envelopes. Patients in the experimental group (OCHL group) will receive a high-carbohydrate beverage (12.6% carbohydrates, 50 kcal/100 mL, 285 mOsm/kg; PreOp®, Nutricia, Zoetermeer, The Netherlands) 800 mL on the evening before surgery (between 9 p.m. and 11 p.m.), and 400 mL 2 hours before the induction of anesthesia. Participants in the no-intervention (control) group will be fasted from midnight until surgery. All other aspects of perioperative patient care will be the same for all participants, as per the standardized Institutional protocol for the treatment of abdominal aortic aneurysms and Leriche Syndrome.

Study Record Dates

• First Submitted: March 23, 2024
• First Posted: April 5, 2024
• Study Start: August 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: April 1, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)