protocolSection identificationModule nctId: NCT06349382, orgStudyIdInfo id: CALAS, briefTitle: CArbohydrate Loading in Aortic Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Belgrade, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Abdominal Aortic Aneurysm, conditions: Leriche Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: carbohydrate-rich beverage, outcomesModule primaryOutcomes measure: The ICU length of stay, primaryOutcomes measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), primaryOutcomes measure: Insulin sensitivity index (HOMA-ISI), primaryOutcomes measure: Homeostasis model assessment of β-cell function (HOMA-β), primaryOutcomes measure: Six aspects of subjective well-being according to the visual analog scale, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: 30-day mortality rate, secondaryOutcomes measure: The incidence of local wound infections, secondaryOutcomes measure: The incidence of postoperative surgical complications, secondaryOutcomes measure: The incidence of postoperative non-surgical complications, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia, city: Belgrade, zip: 11000, country: Serbia, contacts name: Igor Koncar, MD, Ph.D., role: CONTACT, phone: +381668300290, email: dr.koncar@gmail.com, contacts name: Igor Koncar, MD, Ph.D., role: SUB_INVESTIGATOR, contacts name: Ksenija Jovanovic, MD, Ph.D., role: SUB_INVESTIGATOR, contacts name: Ranko Trailovic, MD, role: SUB_INVESTIGATOR, geoPoint lat: 44.80401, lon: 20.46513, hasResults: False