Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04868318 |
| Other study ID # |
109067 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 10, 2021 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
Tungs' Taichung Metroharbour Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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.
