NCT05998902CompletedPhase 3
Optimizing Early Nutrition Support in Severe Stroke-2
Trophic Enteral Feeding Combined With Supplemental Parenteral Nutrition Treatment in Patients With Severe Stroke (OPENS-2): a Multicentre, Prospective, Randomised, Open-label, Blinded-endpoint Trial
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
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 most feared complications of enteral nutrition and can lead to the occurrence of pneumonia. Severe stroke patients are at high risk for aspiration due to some factors such as the reduced level of consciousness, inability to protect the airway and so on. The purpose of this study is to explore the ideal nutrition support strategy for patient with acute severe stroke to help reduce the incidence of PSP and improve the prognosis.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 546 (actual)
- First submitted
- 26 Jul 2023
- Start date
- 20 Dec 2023
- Primary completion date
- 6 Mar 2026
- Lead sponsor
- Wen Jiang-3
- Diseases
- Stroke
- NCT number
- NCT05998902
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 546
- From 20 Dec 2023 to the primary completion date, 6 Mar 2026
- 30 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving parenteral nutrition support
- Antibiotics were used within the previous 7 days
Other illness
- Complicated with the disease which only have life expectancy \< 7 days
- Admission with infection signs
- Dementia or severe disability (mRS\>4) before stroke
- Subarachnoid hemorrhage, cerebral arteriovenous malformation
Lab values
- 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 \[glomerular filtration rate ≤30mL/min or serum creatinine ≥4mg/dL\]
Other
- Contraindications of enteral nutrition
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Hospital of Changsha City Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Chongqing University Three Gorges Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Daping Hospital, The Third Military Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Second Affiliated Hospital of Guangzhou University of Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Affiliated Hospital of Guizhou Medical University Coordinator of this site? Confirm its status | Guiyang | China | Unknown status |
| Qilu Hospital of Shangdong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The Second Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| The PLA 960 Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Gansu Provincal Central Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Unknown status |
| Liaocheng People's Hospital Coordinator of this site? Confirm its status | Liaocheng | China | Unknown status |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| The Second Affiliated Hospital of Xinjiang Medical University Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| People's Hospital of Xinjiang Uygur Autonomous Region Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| Tongji Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Xi 'an No.3 Hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| The First Affiliated Hospital of Xi'an Medical University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Tangdu Hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Department of Neurology, Xijing Hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Shaanxi Second Provincal People's Hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Shannxi Provincal People's Hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Xi'an Gaoxin Hospital Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| Xi'an Central Hospital Coordinator of this site? Confirm its status | Xi’an | China | Unknown status |
| Xianyang Hospital, Yan'an University Coordinator of this site? Confirm its status | Xianyang | China | Unknown status |
| The First People's Hospital of Xianyang Coordinator of this site? Confirm its status | Xianyang | China | Unknown status |
| General Hospital of Ningxia Medical University Coordinator of this site? Confirm its status | Yinchuan | China | Unknown status |
| Yulin No.2 Hospital Coordinator of this site? Confirm its status | Yulin | China | Unknown status |
| Yulin No.1 Hospital Coordinator of this site? Confirm its status | Yulin | China | Unknown status |
| First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.