Comparative study of the efficacy of peptide-based enteral formula and semi-elemental formula in critically ill patients.

JRCT ID: jRCTs031240408

Registered date:16/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Critically ill ICU/EICU patients needing continuous enteral nutrition during ventilation
• Date of first enrollment: 16/10/2024
• Target sample size: 26
• Study type: Interventional
• Intervention(s): After admission to the EICU/ICU, a digestive-form nutrition group (Nexus ST) or semi-digestive-form nutrition (CZ-Hi 1.5) is administered according to the ICU nutrition protocol and EN algorithm in this hospital.

Outcome(s)

• Primary Outcome: Average daily value of gastric residual volume (ml)

Secondary Outcome

1.Incidence of diarrhea, constipation, vomiting, and high gastric residual volume from the initiation of enteral nutrition (EN) through day 7.
2.Number of days EN was administered.
3.Plasma amino acid analysis (39 amino acids) before EN initiation and on day 7 post-EN initiation.
4.Fulfillment rates of target energy and protein intake on days 3 and 7 after EN initiation.
5.Body composition assessments at ICU/EICU admission, at EN initiation, and on day 7 post-EN initiation.
6.Biochemical assessments (ALB, AST, ALT, BUN, CRE, IL-6, CRP) at ICU/EICU admission and on days 3 and 7 after EN initiation.
7.Length of ICU/EICU stay, duration of mechanical ventilation, hospital stay, IMS, and incidence of adverse events.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients admitted to the ICU or EICU who meet the following criteria:
1.Patients aged 18 years or older.
2.Patients expected to require intubated mechanical ventilation for more than 7 days.
3.Patients who, at the time of admission to the ICU or EICU, are assessed by their physician as likely to require enteral nutrition (EN) for more than 7 days.
4.Patients who are scheduled to adapt the ICU nutrition protocol and EN algorithm and start EN within 48 hours of ICU or EICU admission.
5.Patients who have been fully informed about the study, understand it thoroughly, and from whom free and informed consent has been obtained, either personally or through a legally authorized representative.

Exclude criteria

Individuals meeting any of the following criteria will be excluded from the study:
1.Patients with an allergy to milk or soy.
2.Patients who, according to their physician, medically require a different type of enteral nutrition.
3.Patients admitted to the ICU for postoperative observation.
4.Patients expected to be discharged from the ICU or hospital within two days.
5.Patients with gastrointestinal abnormalities (such as gastrointestinal bleeding, perforation, or stricture).
6.Patients who are already receiving nutritional therapy through enteral nutrition (EN) or total parenteral nutrition (TPN) at the time of admission to the ICU or EICU.
7.Patients with severe renal impairment (creatinine levels of 2.0 mg/dL or higher).
8.Patients with severe liver dysfunction (bilirubin levels of 2.0 mg/dL or higher).
9.Patients undergoing renal replacement therapy.
10.Patients receiving analgesic doses significantly exceeding the normal therapeutic range.
11.Patients who are pregnant, may be pregnant, within 28 days postpartum, or are breastfeeding.
12.Patients whom the principal investigator or co-investigator deems unsuitable for safe participation in the study.

Related Information

• Primary Sponsor: Oshima Taku
• Source(s) of Monetary Support: Morinagamilk Industry Clinico Co., Ltd.,Chiba University Hospital