The Effect of peptide-based formula compared with standard polymeric formula by early enteral feeding in critically-ill patients

Phase 3

Recruiting

• Conditions: Critically-ill patients who admitted on medical ICU ward and is prescribed early enteral feeding within 48 hours after admission; Peptide-based formula; tube feeding; critically-ill

• Registration Number: TCTR20220221006
• Lead Sponsor: Thai Otsuka Pharmaceutical Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-21
• Study Completion: 2022-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1 Willing to attend the study with completed inform consent form ,2 Age 18 years old or above at date of consent ,3 Admits on Medical ICU ward ,4 On mechanical ventilator for 2 days or above ,5 Use enteral feeding via NG tube in ICU ward not less than 5 days and up to 14 days ,6 Has risk of malnutrition (5 points or more by Modified Nutric Score evaluation ) ,7 BMI 18-30 kg per m2 , 8 Could be prescribed enteral feeding within 48 hours after ICU admission ,9 Has hemodynamically stable. In case of patient need to take norepinephrine, the dose is not more than 15 microgram per minute or 0.3 microgram per kg per minute

Exclusion Criteria

1 Does not have legal representative,2 Experiences aspiration pneumonia,3 Experiences thyroid disease ,4 Experiences severe hepatic impairment ,5 Experiences renal replacement therapy ,6 Diagnosed to abdominal hypertension ,7 Takes fentanyl more than 2 microgram per kg per hr or morphine more than 0.05 milligram per kg per hr, 8 Has parenteral nutrition administration,9 Experiences food allergy such as Whey Protein, Casein ,10 Diagnosed to incurable disease that could not participate the study such as uncontrolled cancer,11 Experiences chemotherapy or radiotherapy within 6 months ago. (including immunosuppressor taking such as prednisolone 7 days continuously within 4 months before enrolment ,12 Experiences immune disorder such as HIV-positive

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Daily average gastric residual volume every time before feeding IP Gastric Residual Volume measurement,amount of day to reach goal of energy requirement Everyday during study measurement of calories intake per day

Secondary Outcome Measures

Name	Time	Method
parameter of immunity Day 1,3,5,7,9,11,14 IL-6 level ,Parameter of inflammation Day 1,3,5,7,9,11,14 CRP, procalcitonin ,Parameter of biochemistry Day 1,3,5,7,9,11,14 BUN, creatinine, retinol binding protein, prealbumin, electrolyte,total lymphocyte count Day 1,3,5,7,9,11,14 CBC,Nitrogen Balance Day 1,3,5,7,9,11,14 UUN ,mechanical ventilator day Everyday during the study assessment ,ICU length of stay Everyday during the study assessment ,ICU mortality Everyday during the study assessment ,Rate of infection Every during the study assessment ,GI side effect Everyday during the study assessment