Efficacy of Carbohydrate Loading in Diabetic Type 2 Patients Undergoing CABG Surgery on CPB

Обзор

Enhanced recovery after surgery protocols aim to optimize perioperative care and improve surgical outcomes. Preoperative carbohydrate loading has demonstrated benefits in reducing insulin resistance and improving patient outcomes. While non-diabetic patients benefit from this approach, its efficacy in diabetic type 2 patients undergoing CABG remains less understood. This study aims to address this gab by evaluating the physiological and clinical outcomes for carbohydrate loading in this specific population.

Подробное описание

A randomized controlled trial comparing diabetic type 2 patients receiving carbohydrate loading with those undergoing traditional fasting protocols. Patients will be randomized to two groups; group (a) patients will have carbohydrate loading 2 hours before the surgery (400 ml of 12.5 maltodextrin and 400 ml of over-the-counter fruit-based lemonade), while group (b) patients (control group) will have standard fasting protocol 8 hours before surgery.

Aims of the study:

1. To assess the efficacy of carbohydrate loading in reducing insulin resistance in diabetic type 2 patients undergoing CABG surgeries. 2. To monitor clinical outcomes such as infection rates, ICU stay duration, and need for inotropic and vasoactive drugs. 3. To evaluate changes in inflammatory markers including CRP levels. clinical outcome

Вмешательства

• Пищевая добавка Carbohydrate loading before surgery
  Carbohydrate loading 2 hours before the surgery (400 ml of 12.5 maltodextrin and 400 ml of over-the-counter fruit-based lemonade)

Первичные конечные точки

• Short Insulin Tolerance Test (KITT) [Срок оценки: Preoperatively and up to 72 hours postoperatively]

Вторичные конечные точки (8)

• CRP levels [Срок оценки: Preoperatively and up to 72 hours postoperatively]
• Arterial blood gases [Срок оценки: Preoperatively and up to 72 hours postoperatively]
• Operative time [Срок оценки: Intraoperatively, skin-to-skin]
• CPB duration [Срок оценки: Intraoperatively, using extracorporeal circulation]
• Blood loss [Срок оценки: Intraoperatively and up to 72 hours postoperatively]
• Number of grafts performed [Срок оценки: Intraoperatively, skin-to-skin]
• Use of inotrops [Срок оценки: Intraoperatively and up to 72 hours postoperatively]
• Complications [Срок оценки: Intraoperatively and up to 72 hours postoperatively]

Критерии участия

Критерии включения

All diabetic type 2 patients undergoing isolated on-pump coronary artery bypass surgery.

Критерии исключения

• Missing data.
• Patients outside the study period.
• Patients undergoing other cardiac surgeries.
• Patients diagnosed with type 1 diabetes mellitus.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Syria · 1 центр

• Damascus University Cardiac Surgery Hospital — Damascus

Публикации

• Dock-Nascimento DB, de Aguilar-Nascimento JE, Magalhaes Faria MS, Caporossi C, Slhessarenko N, Waitzberg DL. Evaluation of the effects of a preoperative 2-hour fast with maltodextrine and glutamine on insulin resistance, acute-phase response, nitrogen balance, and serum glutathione after laparoscopic cholecystectomy: a controlled randomized trial. JPEN J Parenter Enteral Nutr. 2012 Jan;36(1):43-52 PMID 22235107
• Vermeulen MA, Richir MC, Garretsen MK, van Schie A, Ghatei MA, Holst JJ, Heijboer AC, Uitdehaag BM, Diamant M, Eekhoff EM, van Leeuwen PA, Ligthart-Melis GC. Gastric emptying, glucose metabolism and gut hormones: evaluation of a common preoperative carbohydrate beverage. Nutrition. 2011 Sep;27(9):897-903. doi: 10.1016/j.nut.2010.10.001. Epub 2011 Jan 21. PMID 21255977
• 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
• Breuer JP, von Dossow V, von Heymann C, Griesbach M, von Schickfus M, Mackh E, Hacker C, Elgeti U, Konertz W, Wernecke KD, Spies CD. Preoperative oral carbohydrate administration to ASA III-IV patients undergoing elective cardiac surgery. Anesth Analg. 2006 Nov;103(5):1099-108. doi: 10.1213/01.ane.0000237415.18715.1d. PMID 17056939
• Amer MA, Smith MD, Herbison GP, Plank LD, McCall JL. Network meta-analysis of the effect of preoperative carbohydrate loading on recovery after elective surgery. Br J Surg. 2017 Feb;104(3):187-197. doi: 10.1002/bjs.10408. Epub 2016 Dec 21. PMID 28000931
• Sokolic J, Knezevic D, Kuharic J, Medved I, Sustic A, Zupan Z, Laskarin G, Tadin T, Sotosek Tokmadzic V. Decrease of Perforin Expressing Lymphocytes after On-Pump Coronary Artery Bypass Grafting Surgery Irrespective of Carbohydrate Preoperative Oral Feeding. Heart Surg Forum. 2019 May 22;22(3):E218-E224. doi: 10.1532/hsf.2003. PMID 31237547
• Lee B, Soh S, Shim JK, Kim HY, Lee H, Kwak YL. Evaluation of preoperative oral carbohydrate administration on insulin resistance in off-pump coronary artery bypass patients: A randomised trial. Eur J Anaesthesiol. 2017 Nov;34(11):740-747. doi: 10.1097/EJA.0000000000000637. PMID 28437263
• Rapp-Kesek D, Stridsberg M, Andersson LG, Berne C, Karlsson T. Insulin resistance after cardiopulmonary bypass in the elderly patient. Scand Cardiovasc J. 2007 Apr;41(2):102-8. doi: 10.1080/14017430601050355. PMID 17454835

Идентификаторы

NCT: NCT06951308 · PhD2-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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