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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative Oral Carbohydrate Loading Group | Experimental | Participants will receive 400 mL of a preoperative oral carbohydrate drink (Nutricia preOp®), with intake completed 2 hours prior to anesthesia induction. |
|
| Placebo Group | Placebo Comparator | Participants will receive 400 mL of a water-based, sensory-similar placebo drink, with intake completed 2 hours prior to anesthesia induction. The placebo contains a low concentration of sugar for flavoring to mimic the taste of the carbohydrate drink. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative Oral Carbohydrate Loading | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital-Free Days at 30 (HFD30) | The number of days a patient is both alive and discharged from the hospital within the first 30 days after transplantation. | From the date of liver transplantation up to 30 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Oral Intake | The time interval from the end of the liver transplant surgery to the moment the patient first tolerates oral intake (clear fluids or solid food) without vomiting or significant distress. | From the end of surgery up to hospital discharge, assessed up to 30 days |
| Time to Return of Gastrointestinal Function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maciej Krasnodębski, MD, PhD | Contact | +48225992459 | maciej.krasnodebski@wum.edu.pl | |
| Eryk Siedlecki | Contact | eryk.siedlecki@wum.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Maciej Krasnodębski, MD, PhD | Department of General, Transplant, and Liver Surgery, Medical University of Warsaw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General, Transplant, and Liver Surgery, Medical University of Warsaw | Recruiting | Warsaw | 02-097 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12673740 | Background | Ljungqvist O, Soreide E. Preoperative fasting. Br J Surg. 2003 Apr;90(4):400-6. doi: 10.1002/bjs.4066. | |
| 25121931 | Background | 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. |
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There is no plan to share individual participant data (IPD) to ensure maximal protection of patient privacy and maintain compliance with institutional data protection regulations. Aggregate data and study results will be made available through publication.
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| Placebo | Dietary Supplement | 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. |
|
Defined as the time interval from the end of surgery until the patient first tolerates oral intake (solid or semi-solid food) and passes the first stool. |
| From the end of surgery up to hospital discharge, assessed up to 30 days |
| Incidence of Postoperative Infections | Presence of postoperative infections diagnosed in a patient (e.g., surgical site infection, urinary tract infection, pneumonia, or bloodstream infection). | From the date of liver transplantation up to 30 days post-surgery |
| Length of ICU Stay | The duration of the patient's stay in the Intensive Care Unit (ICU) following liver transplantation. | 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 | Postoperative complications will be assessed and graded according to the Clavien-Dindo classification system. This includes all deviations from the normal postoperative course, ranging from Grade I (minor complications requiring no intervention) to Grade V (death). Each complication will be recorded and its severity will be analyzed. | From the date of liver transplantation up to 30 days post-surgery |
| 20108579 | Background | 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. |
| 33966024 | Background | 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 Recovery After Surgery (ERAS) Recommendations. Transplantation. 2022 Mar 1;106(3):552-561. doi: 10.1097/TP.0000000000003808. |
| 24417824 | Background | 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. |
| ID | Term |
|---|---|
| D058625 | End Stage Liver Disease |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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