End Stage Liver Disease, Liver Transplant, Liver Transplantation, Liver Transplant Surgery
Conditions
Keywords
Preoperative Oral Carbohydrate Loading, POCL, Nutricia PreOp, Liver Transplantation, Liver Transplant, Carbohydrate drink, Preoperative Carbohydrate Loading
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.
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.
Interventions
DIETARY_SUPPLEMENTPreoperative 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.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital-Free Days at 30 (HFD30) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Oral Intake | 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. |
| Time to Return of Gastrointestinal Function | 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. |
| Incidence of Postoperative Infections | 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). |
| Length of ICU Stay | 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. |
| Incidence and Severity of Postoperative Complications | 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. |
Countries
Poland
Contacts
CONTACTMaciej Krasnodębski, MD, PhD
CONTACTEryk Siedlecki
PRINCIPAL_INVESTIGATORMaciej Krasnodębski, MD, PhD
Department of General, Transplant, and Liver Surgery, Medical University of Warsaw
Outcome results
None listed