The Impact of Intervention With High-protein Enteral Formula in SICU.

Trial Design and Patient Population

This study is an investigator-initiated, prospective, randomized controlled trial. This study is conducted according to the guidelines laid down in the Declaration of Helsinki, and all procedures were reviewed as well as approved by the Regional Hospital Ethics Committee. The written informed consent will be obtained before randomization. We will collect subjects' demographic and clinical characteristics on the first and seventh day of the intervention, including age, gender, weight, height, body mass index (BMI), Disease diagnosis, disease severity (The Acute physiology and Chronic Health Evaluation II, APACHE II), Sequential Organ Failure Assessment (SOFA) Score, disease history, ventilator parameters, body temperature, blood pressure, pulse rate and breathing frequency. The complications, length of stay in intensive care unit, total hospitalization Days, hospital mortality, 14-day survival results, 28-day survival results, days of ventilator use will be also recorded.

Patients 20 years of age or older will be eligible for inclusion if they have been admitted to the surgical Intensive Care Unit (SICU) for 24 hours or more. Subjects with enteral nutrition to be clinically contraindicated by treating clinician considered will be excluded. Total of one hundred and sixty patients will be included and randomly assigned into two groups.

Anthropometric and Biochemical Assessments

The patients' caloric requirement will be calculated based on the guidelines for critically ill nutrition treatment published by ASPEN/SCCM in 2016, suggesting that critically ill patients should be given 25 calories per kilogram of ideal body weight. The protein requirement of patients will be calculated based on the 1.5 g/kg/day recommended by the 2017 ESPEN guidelines for the nutritional care of critically ill surgical patients.

The nutritional intake and digestive tract symptoms of the patient within 7 days after entering the intensive care unit will be recorded, including nutritional intake (calories, carbohydrate, protein, fat) of enteral nutrition as well as intravenous nutrition(dosage of propofol, glucose infusion and glucosaline used...etc.),and digestive symptoms (diarrhea, bloating, Abdominal pain, constipation, nausea, vomiting... etc.).

The biochemical assessments of patients will be measured on the first and seventh days of admission to the ICU, including blood routine examination, total lymphocyte counts, creatinine, blood urine nitrogen, alanine aminotransferase (ALT), aspirate aminotransferase (AST), total bilirubin, albumin, prealbumin, total protein, cholesterol, triglyceride, uric acid, electrolyte, C-reactive protein, blood sugar as well as 24-hour urine urea nitrogen (UUN).

Total Lymphocyte Count and Nitrogen Balance are calculated by the following formulae.

Total Lymphocyte Count (cells/mm3) = WBC×% lymphocyte Nitrogen Balance (gm/day) = (protein intake/6.25) - (UUN + 4 g obligatory loss)

Intervention Formula In-kind support will be provided by Nestlé Health Science, which supplied both of the enteral nutrition formulations, Peptamen® Intense VHP and Peptamen®. Peptamen® Intense VHP (37% protein of total energy) and Peptamen® (16% protein of total energy) will be provided to two groups of subjects respectively.

The trial enteral nutrition was administered for at least 3 days up to 7 days or until the patient discontinued enteral nutrition, or was discharged from the ICU, whichever occurred first.