Effect of Preoperative Oral Carbohydrate Loading on Postoperative Outcomes in Liver Transplant Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Warsaw
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
acute liver failure
insulin-dependent diabetes mellitus
gastroparesis
mechanical bowel obstruction
Trial design
Design model
Parallel
Treatments tested in this trial
Preoperative Oral Carbohydrate Loading
Dietary supplementPreoperative 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
Dietary supplementA 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.
Treatment groups
434 Participants
are divided into 2 treatment groupsGroup A: Preoperative Oral Carbohydrate Loading GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
From the date of liver transplantation up to 30 days post-surgerySecondary outcomes
1
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.
Time frame
From the end of surgery up to hospital discharge, assessed up to 30 days2
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.
Time frame
From the end of surgery up to hospital discharge, assessed up to 30 days3
Incidence of Postoperative Infections
Presence of postoperative infections diagnosed in a patient (e.g., surgical site infection, urinary tract infection, pneumonia, or bloodstream infection).
Time frame
From the date of liver transplantation up to 30 days post-surgery4
Length of ICU Stay
The duration of the patient's stay in the Intensive Care Unit (ICU) following liver transplantation.
Time frame
From the date of ICU admission until transfer to a surgical ward or hospital discharge (up to 30 days)Sponsors and contacts
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Source ClinicalTrials.gov