- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04868318
The Impact of Intervention With High-protein Enteral Formula in SICU.
The Impact of Intervention With High-protein Pre-digested Enteral Formula on Clinical Outcomes in Surgical Critically Ill Patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taichung, Taiwan, 435
- PS Lim
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 20 years of age or older.
- Those who have stayed in the surgical intensive care unit for 24 hours or more.
Exclusion Criteria:
- Those who cannot supply enteral nutrition within 3 days due to disease or unstable clinical conditions.
- Those who have been fed for less than three days due to disease or unstable clinical conditions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VHP(very-high protein) group
In VHP(very-high protein) group, we will provide pre-digested formula of 37% protein to the experimental group for at least 3 days to up to 7 days.
|
Peptamen® Intense VHP (37% protein)
|
Active Comparator: SHP(standard-high protein) group
SHP(standard-high protein) group is the control group, standard-high protein formula (16% of energy) would be given to the control group for at least 3 days to up to 7 days.
|
Peptamen® (16% protein)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival rate
Time Frame: 28 days
|
The percentage of people in two-arm group was still alive for 28-days of time after admission to ICU.
|
28 days
|
Survival rate
Time Frame: 14 days.
|
The percentage of people in two-arm group was still alive for 14-days of time after admission to ICU.
|
14 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICU days
Time Frame: 28 days
|
ICU days is the duration of a single episode of ICU.
It is calculated by subtracting day of ICU admission from day of ICU discharge.
|
28 days
|
Hospital days
Time Frame: 28 days
|
Hospital days, be equal length of stay (LOS), is the duration of a single episode of hospitalization.
It is calculated by subtracting day of admission from day of discharge.
|
28 days
|
Length of ventilator
Time Frame: 28 days
|
Length of ventilator is the total days of using ventilator.
It is calculated by recording whether ventilator was used on the day in ICU.
|
28 days
|
Nitrogen balance
Time Frame: 7 days
|
Nitrogen balance, calculated by measuring urine urea nitrogen (UUN) to assess whether the protein state is sufficient.
|
7 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Pei-Rong Li, Tungs' Taichung MetroHarbor Hospital
- Principal Investigator: Yi-Chia Huang, Chung Shan Medical University
- Principal Investigator: Shung-Sheng Tsou, Tungs' Taichung MetroHarbor Hospital
- Study Director: Li-Wa Liao, Tungs' Taichung MetroHarbor Hospital
- Study Chair: Feng-Chan Shi, Tungs' Taichung MetroHarbor Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 109067
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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