Clinical Trials Logo

Clinical Trial Summary

The advantage of higher protein intake has been pointed for critically ill patients. However, it is not easy to achieve no overfeeding but adequate protein intakes for critically ill patients. It is thus important to conduct a strategy to deliver an adequate protein under but no overfeeding for critically ill patients. The purpose of this study is to investigate the association of protein intakes with clinical outcomes by delivering high-protein pre-digested enteral formula to surgical critically ill patients. We are going to recruit 160 surgical critically ill patients. Patients would be randomly assigned to either control or experimental group. Very-high protein pre-digested formula (37% of energy) would be given to the experimental group, while standard-high protein formula (16% of energy) would be given to the control group for at least 3 days to up to 7 days. The patients' data were collected or calculated and included basic characteristics, mean energy and protein intakes, clinical outcomes (APACHE II score, comorbidities, days in hospital to ICU admission, length of ventilator dependence, hospital and ICU stays, and survival days). We anticipated that the results of this study could provide the benefit of high protein delivery on clinical outcomes for critically ill patients.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04868318
Study type Interventional
Source Tungs' Taichung Metroharbour Hospital
Contact Pei-Rong Li
Phone 886-4-26581919
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date May 10, 2021
Completion date December 31, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT04551508 - Delirium Screening 3 Methods Study
Active, not recruiting NCT03671447 - Enhanced Recovery After Intensive Care (ERIC) N/A
Recruiting NCT03941002 - Continuous Evaluation of Diaphragm Function N/A
Recruiting NCT04674657 - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Completed NCT04239209 - Effect of Intensivist Communication on Surrogate Prognosis Interpretation N/A
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Recruiting NCT04479254 - The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study) N/A
Recruiting NCT04475666 - Replacing Protein Via Enteral Nutrition in Critically Ill Patients N/A
Not yet recruiting NCT03890432 - GLUCOSAFE 2 - A New Tool for Nutritional Management and Insulin-therapy in the Intensive Care Unit N/A
Not yet recruiting NCT04516395 - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae N/A
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting NCT04043091 - Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction Phase 3
Recruiting NCT02989051 - Fluid Restriction Keeps Children Dry Phase 2/Phase 3
Recruiting NCT02922998 - CD64 and Antibiotics in Human Sepsis N/A
Completed NCT03048487 - Protein Consumption in Critically Ill Patients
Completed NCT02899208 - Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients? N/A
Recruiting NCT02163109 - Oxygen Consumption in Critical Illness
Completed NCT02358577 - Early In-bed Cycling in Critically Ill Children Phase 1/Phase 2
Completed NCT03099746 - Decision Support Among Surrogate Decision Makers of the Chronically Critically Ill (INVOLVE) N/A
Withdrawn NCT02169193 - Diagnosis of Microaspiration in Intubated Critically Ill Patients: Pepsin vs 99m Technetium N/A