Enteral Nutrition, Severe Stroke
Conditions
Keywords
Stroke, Enteral Nutrition
Brief summary
This is a single-center, randomized, exploratory clinical trial investigating whether intermittent enteral feeding improves outcomes compared to continuous feeding in patients with severe stroke. The study will enroll 60 patients to evaluate the impact on 90-day all-cause mortality, neurological function, nutritional status, and safety. It will also explore underlying mechanisms through analysis of metabolic profiles, circadian gene expression, and gut microbiota.
Interventions
BEHAVIORALIntermittent Enteral Feeding
Participants randomized to this group will receive enteral nutrition via a nasogastric or nasojejunal tube using an intermittent, daytime-only feeding schedule designed to align with the physiological circadian rhythm.
BEHAVIORALContinuous Enteral Feeding
Participants randomized to this group will receive enteral nutrition via a nasogastric or nasojejunal tube using the standard, continuous 24-hour feeding method commonly employed in critical care settings.
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years old 2. It was definitely diagnosed as acute stroke by clinical imaging. 3. Enteral nutrition program can be started within 72 hours of onset. 4. Baseline GCS≤12 or NIHSS≥11 5. There is nutritional risk (NRS 2002≥3), Wadian drinking water test≥ 3 or there is consciousnessdisorder,it is estimated that you need to receive nutritional support treatment for ≥7 days 6. Obtain informed consent
Exclusion criteria
1. Before joining the group, he had received total parenteral nutrition treatment. 2. There are contraindications to enteral nutrition. 3. Unstable vital signs 4. Dementia or severe disability before onset (mRS≥3) 5. There are concomitant diseases that will interfere with outcome evaluation and/or follow-up. 6. Participating in other interventional clinical trials. 7. Other circumstances in which the study cannot be completed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality | 90 days post-randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 90-day unfavorable outcome rate | at 90 days | Defined as a modified Rankin Scale (mRS) score of 3-6 |
| Nutritional status indicators | Baseline and Day 7 assessments | Serum albumin (ALB); Serum prealbumin (PAB); Serum total protein (TP); Hemoglobin (HB) levels; Mid-upper arm circumference (MUAC); Triceps skinfold thickness (TSF) |
| Activities of daily living | 90 days post-randomization | Barthel Index (BI) |
| Incidence of gastrointestinal intolerance | Throughout the intervention period (expected ≥7 days) | Gastric retention; diarrhea; constipation and gastrointestinal bleeding |
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Throughout the study period (up to 90-day follow-up). | — |
| Neurological deficit score | at Day 3 and Day 7 post-randomization | National Institutes of Health Stroke Scale (NIHSS) score |
Contacts
CONTACTJingjing Zhao
Outcome results
None listed