Effect of Preoperative Oral Carbohydrate Loading on Postoperative Outcomes in Liver Transplant Patients
1 other identifier
interventional
434
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2026
CompletedFirst Posted
Study publicly available on registry
April 9, 2026
CompletedStudy Start
First participant enrolled
May 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
June 3, 2026
May 1, 2026
2.2 years
March 27, 2026
June 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
Time to First Oral Intake
From the end of surgery up to hospital discharge, assessed up to 30 days
Time to Return of Gastrointestinal Function
From the end of surgery up to hospital discharge, assessed up to 30 days
Incidence of Postoperative Infections
From the date of liver transplantation up to 30 days post-surgery
Length of ICU Stay
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
From the date of liver transplantation up to 30 days post-surgery
Study Arms (2)
Preoperative Oral Carbohydrate Loading Group
EXPERIMENTALParticipants will receive 400 mL of a preoperative oral carbohydrate drink (Nutricia preOp®), with intake completed 2 hours prior to anesthesia induction.
Placebo Group
PLACEBO COMPARATORParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- acute liver failure
- insulin-dependent diabetes mellitus
- gastroparesis
- mechanical bowel obstruction
- liver retransplantation within less than 6 months of the primary transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of General, Transplant, and Liver Surgery, Medical University of Warsaw
Warsaw, 02-097, Poland
Related Publications (5)
Ljungqvist O, Soreide E. Preoperative fasting. Br J Surg. 2003 Apr;90(4):400-6. doi: 10.1002/bjs.4066.
PMID: 12673740BACKGROUNDSmith 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: 25121931BACKGROUNDLjungqvist 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: 20108579BACKGROUNDBrustia 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.
PMID: 33966024BACKGROUNDBilku 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: 24417824BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maciej Krasnodębski, MD, PhD
Department of General, Transplant, and Liver Surgery, Medical University of Warsaw
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2026
First Posted
April 9, 2026
Study Start
May 27, 2026
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
June 3, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
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.