Clinical Trials Logo

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.


Recruitment information / eligibility

Status Completed
Enrollment 280
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Very-high protein enteral formula
Peptamen® Intense VHP (37% protein)
Standard-high protein enteral formula
Peptamen® (16% protein)

Locations

Country Name City State
Taiwan PS Lim Taichung

Sponsors (1)

Lead Sponsor Collaborator
Tungs' Taichung Metroharbour Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival rate The percentage of people in two-arm group was still alive for 28-days of time after admission to ICU. 28 days
Primary Survival rate The percentage of people in two-arm group was still alive for 14-days of time after admission to ICU. 14 days.
Secondary ICU 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
Secondary Hospital 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
Secondary Length of ventilator 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
Secondary Nitrogen balance Nitrogen balance, calculated by measuring urine urea nitrogen (UUN) to assess whether the protein state is sufficient. 7 days
See also
  Status Clinical Trial Phase
Completed NCT04551508 - Delirium Screening 3 Methods Study
Recruiting NCT06037928 - Plasma Sodium and Sodium Administration in the ICU
Completed 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
Completed NCT05531305 - Longitudinal Changes in Muscle Mass After Intensive Care 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
Completed NCT02916004 - The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients. N/A
Recruiting NCT05883137 - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Completed 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 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
Withdrawn NCT04043091 - Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction N/A
Recruiting NCT02989051 - Fluid Restriction Keeps Children Dry Phase 2/Phase 3
Recruiting NCT02922998 - CD64 and Antibiotics in Human Sepsis N/A
Completed NCT02899208 - Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients? N/A
Completed NCT03048487 - Protein Consumption in Critically Ill Patients
Recruiting NCT02163109 - Oxygen Consumption in Critical Illness