Liver TransplantationNCT07519057
Effect of Preoperative Oral Carbohydrate Loading on Postoperative Outcomes in Liver Transplant Patients
A study testing Preoperative Oral Carbohydrate Loading in people with Liver Transplantation and Liver Transplant, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Liver Transplant, Liver Transplant Surgery
- What is being tested?
- Preoperative Oral Carbohydrate Loading
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 434 participants
- Where
- 1 sitePoland
- Study dates
- 27 May 2026to Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- acute liver failure
- insulin-dependent diabetes mellitus
- gastroparesis
- mechanical bowel obstruction
- liver retransplantation within less than 6 months of the primary transplant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eryk Siedlecki contact
Poland1 site, 1 recruiting
- Recruiting
Department of General, Transplant, and Liver Surgery, Medical University of Warsaw
Warsaw, 02-097
Maciej Krasnodębski, MD, PhD, +48225992459, maciej.krasnodebski@wum.edu.pl
Eryk Siedlecki, eryk.siedlecki@wum.edu.pl
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Transplantation, Liver Transplant, Liver Transplant Surgery, End Stage Liver Disease
- Being tested
- Preoperative Oral Carbohydrate Loading, Placebo
- Keywords
- Preoperative Oral Carbohydrate Loading, POCL, Nutricia PreOp, Liver Transplantation, Liver Transplant, Carbohydrate drink, Preoperative Carbohydrate Loading
- Medical subject headings
- End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Oral Carbohydrate LoadingDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Preoperative Oral Carbohydrate Loading |
| 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the date of liver transplantation up to 30 days post-surgery
Secondary outcomes (5)
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.
Measured: From the end of surgery up to hospital discharge, assessed up to 30 days
Time to Return of Gastrointestinal Function
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From the date of liver transplantation up to 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start27 May 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 434 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maciej Krasnodębski, MD, PhD, Principal investigator, Department of General, Transplant, and Liver Surgery, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519057
- Sponsor's protocol ID
- KB/39/2026
- Status last verified
- May 2026
- First submitted
- 27 Mar 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Ljungqvist O, Soreide E. Preoperative fasting. Br J Surg. 2003 Apr;90(4):400-6. doi: 10.1002/bjs.4066.
PubMed 12673740Smith 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.
PubMed 25121931Ljungqvist 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.
PubMed 20108579Brustia 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.
PubMed 33966024Bilku 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.
PubMed 24417824