LOME-PECT trial (LOME-PECT trial)
- Conditions
- Patients admitted to ICU (critically ill) who need to be controlled with EN preparations
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
(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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method - Incidence of diarrhea within 3 days of study product administration
- Secondary Outcome Measures
Name Time Method Survival rate 28 days after the start of the study product administration Survival rate at 28 days after the start of the study product administration
Hospitalization days Hospitalization days
Number of ventilatory days Number of ventilatory days
Nutritional endpoints days 7 and 14 WBC, lymphocyte count, CRP, albumin, prealbumin, total cholesterol, triglycerides (days 7 and 14)
Barthel Index day 28 after the start of treatment Barthel Index at day 28 after the start of treatment with the study product
Incidence of intestinal intolerance events Incidence of intestinal intolerance events
Incidence of infectious events 28 days of study product administration Incidence of infectious events within 28 days of study product administration
Bristol Scale diarrhea days 1, 2, and 3 of treatment 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)
Diarrhea (Bristol Scale 5, 6, or 7) first week after the start of treatment Diarrhea (as defined by Bristol Scale 5, 6, or 7) in the first week after the start of treatment with the test product
Failure rate of EN days 3 and 7 of treatment Failure rate of EN on days 3 and 7 of treatment with study product
Duration of EN administration Duration of EN administration
Daily energy and protein dose first 7 days after the start of treatment Daily energy and protein dose for EN and intravenous nutrition during the first 7 days after the start of treatment with the study product
Number of days in ICU Number of days in ICU