Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT05998902
Eligibility Criteria:
Inclusion Criteria:
1. Age≥18 years
2. Definite diagnosis of acute stroke (GCS ≤12 or NIHSS≥11)
3. The randomized nutritional treatment could be initiated up to 72 hours after symptom onset.
4. Any cases of profiles #3 through 5 in Water Swallowing Test or with disorder of consciousness.
5. Plan to receive nutritional support treatment for at least 7 days.
6. Informed consent.
Exclusion Criteria:
1. Receiving parenteral nutrition support
2. Contraindications of enteral nutrition
3. Complicated with the disease which only have life expectancy \< 7 days
4. Admission with infection signs
5. Dementia or severe disability (mRS\>4) before stroke
6. Antibiotics were used within the previous 7 days
7. Subarachnoid hemorrhage, cerebral arteriovenous malformation
8. Presence of coexisting medical conditions that could interfere with outcome assessment and/or follow-up (a. advanced cancer; b. severe pulmonary dysfunction \[forced expiratory volume in 1 second \< 50% or/and moderate to severe acute lung injury (PaO2/FiO2)\<200mmHg\]; c. cardiac insufficiency (NYHA class \> I; cardiac structural and/or functional abnormalities such as EF\< 50%, abnormal cardiac chamber enlargement, moderate/severe ventricular hypertrophy, or moderate/severe valvular stenosis); d. Severe liver failure \[Child-Pugh score≥7\]; e. Severe renal failure \[glomerular filtration rate ≤30mL/min or serum creatinine ≥4mg/dL\]
9. Currently participating in other clinical trial
10. Pregnant woman
11. Patient who is considered highly likely not to adhere to the study treatment or follow-up protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05998902
Study Brief:
Protocol Section:
NCT05998902