NCT07519057

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 434 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 (block randomization in blocks of 10 participants, with the final block consisting of 7 allocations) 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. 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.

Conditions

• Liver Transplantation
• Liver Transplant
• Liver Transplant Surgery
• End Stage Liver Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: Poland