Diluted and Undiluted Enteral Nutrition
NCT Number: NCT06516835
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Critical Illness|Surgery|Enteral Feeding Intolerance|Gastro-Intestinal Disorder|Quality of Life
Interventions: OTHER: Enteral fluid|OTHER: Intravenous fluid
Sponsor: Medical University of Lublin
Collaborators: Nutricia Fundation|Catholic University of Lublin
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
Start Date: 2025-01-02
Completion Date: 2027-04-30
Locations: Provincial Hospital in Gorzow Wielkopolski, Gorzów Wielkopolski, 66-400, Poland|Fifth Military Hospital, Kraków, 30-901, Poland|First Military Hospital, Lublin, 20-049, Poland|II Department of Anesthesia and Intensive Care, Medical University of Lublin, Lublin, 20-081, Poland|Provincial Hospital in Opole, Opole, 45-372, Poland

Summary:
Adult patients after elective major abdominal surgeries who are planned to be admitted to the Intensive Care Unit (ICU) can be included in the trial.

Each patient will be fed via the gastrointestinal tract. Half of the patients will receive enteral nutrition (EN) with additional fluids, and the rest will receive undiluted EN.

The primary aim of this study is feeding intolerance assessment in both groups of patients.

Primary Outcome Measures: Number of participants having nausea and vomiting, Incidents of nausea and vomiting (nausea measured with a 4-point verbal descriptive scale (0=no nausea, 1=mild, 2=moderate, 3=severe)), From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Number of participants having diarrhea, Incidents of diarrhea (≥ three loose stools per day), From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Number of participants having increased gastric residual volume, Increased gastric residual volume (\> 500 ml of gastric aspirate/ 6 hours). Only in patients after lower GI tract surgeries (with intact stomach and gastric feeding), From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Number of participants in whom target EN will not be achieved, Achieving target EN on day three and later: 80% of protein requirements according to ESPEN (1.3/kg of ideal body weight (patients BMI \< 30) or adjusted body weight, BMI ≥ 30), From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Number of participants in whom prokinetic agents will be used, Administration of prokinetic agents according to the intensivist discretion. Starting with both erythromycin (125 mg twice daily enterally) and metoclopramide (10mg three times per day i.v.), From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first
Secondary Outcome Measures: Days of support with PN, Days of support with parenteral nutrition during the ICU stay., From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Contribution of PN in total nutrition, Percentage contribution of parenteral nutrition in total patient feeding understand as protein demands, From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Insulin consumption, Insulin consumption - units per day and total per stay, From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Electrolyte supplementation, Electrolyte supplementation - potassium, phosphorus, calcium, and magnesium in mmol/ stay, From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Enteral access obstruction, Need for replacement outside the ICU or under endoscopy assistance. Number of such procedures per stay., From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Intraabdominal pressure, Intraabdominal pressure via urinary catheter twice daily, From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Sequential Organ Failure Assessment Score (SOFA), Calculating SOFA twice daily - from 0 to 24 - 0 means the lack of organ failure; 24 multiorgan failure, From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Fluid balance, Additional crystalloids or colloids given intravenously during ICU stay measured in milliliters, From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Blood products transfusion, Transfusion of any blood products, including red-packed cells, fresh-frozen plasma, platelets, and cryoprecipitate, measured in units per stay., From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Acute kidney injury (AKI), Recognition of AKI according to Kidney Disease: Improving Global Outcomes (KDIGO) definition, From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Vasoactive drugs, Usage of vasoactive drugs including noradrenaline, dobutamine, dopamine, adrenaline, and others measured in milligrams as cumulative dose per stay, From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Stroke volume variation, Measurement of stroke volume variation presented in percent twice daily during the patient stay, From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Cardiac output, Measurement of cardiac output (L/min) with pulmonary thermodilution technique twice daily during the patient's stay, From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Systemic vascular resistance, Measurement of systemic vascular resistance (dynes/sec/cm-5) with pulmonary thermodilution technique twice daily during the patient's stay, From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Extravascular lung water, Measurement of extravascular lung water index (ml/kg) with pulmonary thermodilution technique twice daily during the patient's stay, From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Lactates, At least once daily, arterial blood lactates (mmol/L) will be measured, From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Complete blood count (CBC), Once daily CBC will be tested, From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Blood proteins, Plasma protein concentrations (g/dL) will measured at least once a week., From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Infection site, Site of infection during the ICU stay., From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Antibiotics, Antibiotics wchich will be used in ICU., From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Blood albumins, Plasma albumin concentrations (g/dL) will measured at least once a week., From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|C-reactive protein (CRP), CRP (mg/L) will be measured once daily., From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Procalcitonin (PCT), PCT (ng/mL) will be measured once daily., From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Mechanical ventilation, Mechanical ventilation time in hours per stay, From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Intensive care unit (ICU) stay, ICU stay in days, From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Hospital stay, Hospital stay in days, From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Hospital mortality, In-hospital mortality, From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Intestinal fatty-acid binding protein (I-FABP), I-FABP concentrations (nmol/mL) will be measured in the blood and urine once daily., From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Zonulin, Zonulin concetration (ng/mL) will measured in the patient's blood on the 1st day, 4th day, and at the ICU discharge., From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Ketones, Serum ketone concentrations (mmol/L) will be collected and measured at ICU admission, 4th day, and discharge, From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Microbiome, Intestinal microbiome collection upon admission and discharge from the ICU. Sequencing of the V3 V4 region of the 16SrRNA gene using NGS using Illumina technology, 2x250 bp, min. 100,000 readings, including DNA isolation. Preparation of the OTU table and basic alpha biodiversity measures, From the date of randomization until the date of the ICU discharge or death but no longer than 8 weeks, whichever came first|Quality of recovery, Phone interview using a modified version of Quality of recovery-40 scale (37-185 points,more points better) 30 days after randomization, 30 days after randomization