Effect of Preoperative Oral Carbohydrate Loading on Postoperative Outcomes in Liver Transplant Patients

Официальное название

Effect of Preoperative Oral Carbohydrate Loading on Postoperative Outcomes in Liver Transplant Patients: A Randomized, Placebo-Controlled Trial

Обзор

The aim of the study is to evaluate the effect of preoperative oral carbohydrate loading on postoperative outcomes in liver transplant recipients. The results of this study may contribute to improving recovery after liver transplantation and shortening postoperative hospital stay in these patients. Participants will be randomly assigned to either the study group or the control group. Patients assigned to the study group will receive 400 mL of a carbohydrate beverage (Nutricia preOp®), to be consumed up to 2 hours before the anesthesia induction. Patients assigned to the control group will receive 400 mL of a placebo administered in an identical manner as in the study group. Participants will not be informed which group they have been assigned to. In the postoperative period, routine laboratory and imaging tests will be performed, and their results will be used to assess the effects of the intervention. Follow-up of the patient's clinical course is planned for up to 30 days after surgery. The schedule of follow-up visits will not differ from standard clinical practice.

Подробное описание

The aim of the study is to evaluate the effect of preoperative oral carbohydrate loading on postoperative recovery in liver transplant recipients. Additionally, the study aims to assess the effect of preoperative oral carbohydrate loading on additional recovery parameters following liver transplantation, such as length of stay in the intensive care unit, time to first oral intake, and time to recovery of gastrointestinal function.

Participants will be randomly assigned in a 1:1 ratio to the study group or control group using block randomization with a block size of 10. A randomization list of 440 allocations will be generated prior to enrolment. Recruitment will end after the planned sample size of 434 participants is achieved and remaining allocations will not be used. Patients assigned to the study group will receive 400 mL of a carbohydrate beverage (Nutricia preOp®), to be consumed up to 2 hours before the anesthesia induction. Patients assigned to the control group will receive 400 mL of a placebo administered in an identical manner as in the study group. Participants will not be informed which group they have been assigned to.

In the postoperative period, routine laboratory and imaging tests will be performed, and their results will be used to assess the effects of the intervention. Follow-up of the patient's clinical course is planned for up to 30 days after surgery. The schedule of follow-up visits will not differ from standard clinical practice. No biological material will be collected or stored for the purposes of this study.

Hospital-Free Days at 30 (HFD30), defined as the number of days a patient is both alive and discharged from the hospital within the first 30 days after transplantation, will serve as the primary endpoint, reflecting early postoperative recovery. Based on retrospective data, the mean number of HFD30 was 9.4, with a standard deviation (SD) of 7.1. To detect a 2-day difference with 80% power and a two-sided alpha of 0.05, assuming a 10% early postoperative loss, a total of 434 patients (217 per group) will be required.

Вмешательства

• Пищевая добавка Preoperative Oral Carbohydrate Loading
  Preoperative Oral Carbohydrate Loading will be administered as 400 mL of Nutricia preOp® beverage. It is an iso-osmolar, maltodextrin-based carbohydrate solution containing 12.6 g of carbohydrates per 100 mL.
• Пищевая добавка Placebo
  A water-based solution (400 mL) containing a low concentration of sugar for flavoring to match the taste of the experimental intervention, with no intended therapeutic or nutritional effect.

Первичные конечные точки

• Hospital-Free Days at 30 (HFD30) [Срок оценки: From the date of liver transplantation up to 30 days post-surgery]

Вторичные конечные точки (5)

• Time to First Oral Intake [Срок оценки: From the end of surgery up to hospital discharge, assessed up to 30 days]
• Time to Return of Gastrointestinal Function [Срок оценки: From the end of surgery up to hospital discharge, assessed up to 30 days]
• Incidence of Postoperative Infections [Срок оценки: From the date of liver transplantation up to 30 days post-surgery]
• Length of ICU Stay [Срок оценки: From the date of ICU admission until transfer to a surgical ward or hospital discharge (up to 30 days)]
• Incidence and Severity of Postoperative Complications [Срок оценки: From the date of liver transplantation up to 30 days post-surgery]

Критерии участия

Критерии включения

• age ≥ 18 years
• elective liver transplantation at the Department of General, Transplant, and Liver Surgery, Medical University of Warsaw
• grafts from brain-dead donors
• MELD score <35

Критерии исключения

• acute liver failure
• insulin-dependent diabetes mellitus
• gastroparesis
• mechanical bowel obstruction
• liver retransplantation within less than 6 months of the primary transplant

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

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Польша · 1 центр

• Department of General, Transplant, and Liver Surgery, Medical University of Warsaw — Warsaw

Публикации

• Ljungqvist O, Soreide E. Preoperative fasting. Br J Surg. 2003 Apr;90(4):400-6. doi: 10.1002/bjs.4066. PMID 12673740
• Smith MD, McCall J, Plank L, Herbison GP, Soop M, Nygren J. Preoperative carbohydrate treatment for enhancing recovery after elective surgery. Cochrane Database Syst Rev. 2014 Aug 14;2014(8):CD009161. doi: 10.1002/14651858.CD009161.pub2. PMID 25121931
• Ljungqvist O. Modulating postoperative insulin resistance by preoperative carbohydrate loading. Best Pract Res Clin Anaesthesiol. 2009 Dec;23(4):401-9. doi: 10.1016/j.bpa.2009.08.004. PMID 20108579
• Brustia R, Monsel A, Skurzak S, Schiffer E, Carrier FM, Patrono D, Kaba A, Detry O, Malbouisson L, Andraus W, Vandenbroucke-Menu F, Biancofiore G, Kaido T, Compagnon P, Uemoto S, Rodriguez Laiz G, De Boer M, Orloff S, Melgar P, Buis C, Zeillemaker-Hoekstra M, Usher H, Reyntjens K, Baird E, Demartines N, Wigmore S, Scatton O. Guidelines for Perioperative Care for Liver Transplantation: Enhanced Rec PMID 33966024
• Bilku DK, Dennison AR, Hall TC, Metcalfe MS, Garcea G. Role of preoperative carbohydrate loading: a systematic review. Ann R Coll Surg Engl. 2014 Jan;96(1):15-22. doi: 10.1308/003588414X13824511650614. PMID 24417824

Идентификаторы

NCT: NCT07519057 · KB/39/2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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