Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07519057

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

Led by Medical University of Warsaw · Updated on 2026-06-03

434

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effect of preoperative oral carbohydrate loading on recovery after liver transplantation. It seeks to assess whether drinking a carbohydrate beverage before surgery can improve postoperative outcomes like shortening hospital stay, reducing intensive care unit time, and speeding up the return of gastrointestinal function. The trial involves adult patients undergoing elective liver transplantation with grafts from brain-dead donors and a MELD score below 35. Participants will be randomly assigned to one of two groups. The study group receives 400 mL of a carbohydrate drink called Nutricia preOp®, consumed up to 2 hours before anesthesia starts. The control group receives 400 mL of a water-based placebo drink with a similar taste and appearance, also taken up to 2 hours before anesthesia. Neither the participants nor the researchers know which group each patient is in. Follow-up includes routine lab and imaging tests during the hospital stay and clinical monitoring for 30 days after surgery. Patients will be monitored through standard postoperative tests and clinical visits, with no additional biological samples collected for the study. Researchers will measure the primary outcome of Hospital-Free Days at 30 (HFD30), which counts days alive and discharged within 30 days post-transplant. Secondary outcomes include time to first oral intake, return of gastrointestinal function, infections, length of ICU stay, and postoperative complications. The follow-up schedule follows usual clinical practice, spanning up to 30 days after liver transplantation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Elective liver transplantation at the Medical University of Warsaw
  • Liver graft from a brain-dead donor
  • MELD score less than 35
Not Eligible

You will not qualify if you...

  • Acute liver failure
  • Insulin-dependent diabetes mellitus
  • Gastroparesis
  • Mechanical bowel obstruction
  • Liver retransplantation within less than 6 months from primary transplant

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day (preoperative period)

Participants receive either a preoperative oral carbohydrate drink or a placebo drink up to 2 hours before anesthesia induction as part of liver transplantation preparation.

1 preoperative visit (in-person)

Post-operative Follow-up

Duration - Up to 30 days post-surgery

Participants are monitored for recovery after liver transplantation with routine laboratory and imaging tests and clinical assessments up to 30 days after surgery.

Follow-up visits as part of standard clinical practice

Trial Site Locations

Total: 1 location

1

Department of General, Transplant, and Liver Surgery, Medical University of Warsaw

Warsaw, Poland, 02-097

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Research Team

M

Maciej Krasnodębski, MD, PhD

E

Eryk Siedlecki

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Guidelines for Perioperative Care for Liver Transplantation: Enhanced Recovery After Surgery (ERAS) Recommendations.

Raffaele Brustia, Antoine Monsel, Stefano Skurzak...

https://pubmed.ncbi.nlm.nih.gov/33966024