Status:
RECRUITING
Optimizing Early Nutrition Support in Severe Stroke-2
Lead Sponsor:
Wen Jiang-3
Collaborating Sponsors:
Tang-Du Hospital
Xi'an Central Hospital
Conditions:
Severe Stroke
Acute Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Post stroke pneumonia (PSP) is one of the common early complications of stroke. Post-stroke infections, in general, are associated with less favorable neurologic outcomes. Aspiration is one of the mos...
Detailed Description
As one of the most common complication of stroke, some studies showed that post-stroke pneumonia (PSP) in stroke patients requiring intensive care is associated with an increase of ICU length of stay ...
Eligibility Criteria
Inclusion
- Age≥18 years
- Definite diagnosis of acute stroke (GCS ≤12 or NIHSS≥11)
- The randomized nutritional treatment could be initiated up to 72 hours after symptom onset.
- Any cases of profiles #3 through 5 in Water Swallowing Test or with disorder of consciousness.
- Plan to receive nutritional support treatment for at least 7 days.
- Informed consent.
Exclusion
- Receiving parenteral nutrition support
- Contraindications of enteral nutrition
- Complicated with the disease which only have life expectancy \< 7 days
- Admission with infection signs
- Dementia or severe disability (mRS\>4) before stroke
- Antibiotics were used within the previous 7 days
- Subarachnoid hemorrhage, cerebral arteriovenous malformation
- 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 \[glomerular filtration rate ≤30mL/min or serum creatinine ≥4mg/dL\]
- Currently participating in other clinical trial
- Pregnant woman
- Patient who is considered highly likely not to adhere to the study treatment or follow-up protocol.
Key Trial Info
Start Date :
December 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2026
Estimated Enrollment :
546 Patients enrolled
Trial Details
Trial ID
NCT05998902
Start Date
December 20 2023
End Date
October 31 2026
Last Update
May 28 2025
Active Locations (30)
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1
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China, 404100
2
Daping Hospital, The Third Military Medical University
Chongqing, Chongqing Municipality, China
3
Gansu Provincal Central Hospital
Lanzhou, Gansu, China
4
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China