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

June 1, 2026 updated by: Medical University of Warsaw

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

434

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Warsaw, Poland, 02-097
        • Recruiting
        • Department of General, Transplant, and Liver Surgery, Medical University of Warsaw
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maciej Krasnodębski, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preoperative Oral Carbohydrate Loading Group
Participants will receive 400 mL of a preoperative oral carbohydrate drink (Nutricia preOp®), with intake completed 2 hours prior to anesthesia induction.
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.
Placebo Comparator: Placebo Group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital-Free Days at 30 (HFD30)
Time Frame: From the date of liver transplantation up to 30 days post-surgery
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Oral Intake
Time Frame: From the end of surgery up to hospital discharge, assessed up to 30 days
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
Time Frame: From the end of surgery up to hospital discharge, assessed up to 30 days
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
Time Frame: From the date of liver transplantation up to 30 days post-surgery
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
Time Frame: From the date of ICU admission until transfer to a surgical ward or hospital discharge (up to 30 days)
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
Time Frame: From the date of liver transplantation up to 30 days post-surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Principal Investigator: Maciej Krasnodębski, MD, PhD, Department of General, Transplant, and Liver Surgery, Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB/39/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End Stage Liver Disease

Clinical Trials on Preoperative Oral Carbohydrate Loading

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe