LOME-PECT trial

JRCT ID: jRCTs031230684

Registered date:08/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients admitted to ICU (critically ill) who need to be controlled with EN preparations
• Date of first enrollment: 08/03/2024
• Target sample size: 200
• Study type: Interventional

Intervention(s)

Study treatment group: HYNEX RENUTE was administered via feeding tube for 3 days.
Control treatment group: Glucerna-REX administered via feeding tube for 3 days.

Outcome(s)

• Primary Outcome: Incidence of diarrhea within 3 days of study product administration

Secondary Outcome

1) Bristol Scale diarrhea on days 1, 2, and 3 of treatment with the test product, diarrhea(200 g/day, or 300 ml/day) and soluble diarrhea (>=3 times/day).
2) Diarrhea (as defined by Bristol Scale 5, 6, or 7) in the first week after the start of treatment with the test product
3) Failure rate of EN on days 3 and 7 of treatment with study product
4) Duration of EN administration
5) Daily energy and protein dose for EN and intravenous nutrition during the first 7 days after the start of treatment with the study product
6) Survival rate at 28 days after the start of the study product administration
7) Number of days in ICU
8) Hospitalization days
9) Number of ventilatory days
10) Nutritional endpoints: WBC, lymphocyte count, CRP, albumin, prealbumin, total cholesterol, triglycerides (days 7 and 14)
11) Barthel Index at day 28 after the start of treatment with the study product.
12) Incidence of intestinal intolerance events
13) Incidence of infectious events within 28 days of study product administration

Key inclusion & exclusion criteria

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

Include criteria

(1)Patients admitted to ICU (regardless of reason for admission)
(2)Patients aged 18 years of age or older at the time of enrolment
(3)Patients indicated for EN by transgastric administration
(4)Patients who have given written, free and voluntary consent to participate in this study, either by themselves or by a surrogate

Exclude criteria

(1)Patients for whom EN had been performed within 30 days prior to enrollment
(2)Patients with diarrhea at enrollment; Bristol scale >=5 (Bristol scale 5, 6, or 7 points)
(3)Patients with contraindications or medical inappropriateness (including allergies) to EN by transgastric administration of this nutrient
(4)Patients with DNR/BSC policy
(5)Patients for whom EN is performed by PEG/PTEG
(6)Other cases judged as inappropriate by the investigator

Related Information

• Primary Sponsor: Nakamura Kensuke
• Secondary Sponsor: Otsuka Pharmaceutical Factory, Inc.