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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

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Hospital of Changsha City
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ChangshaChinaUnknown status
Chongqing University Three Gorges Hospital
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ChongqingChinaUnknown status
Daping Hospital, The Third Military Medical University
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ChongqingChinaUnknown status
Nanfang Hospital, Southern Medical University
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GuangzhouChinaUnknown status
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
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GuangzhouChinaUnknown status
The Affiliated Hospital of Guizhou Medical University
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GuiyangChinaUnknown status
Qilu Hospital of Shangdong University
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JinanChinaUnknown status
The Second Hospital of Shandong University
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JinanChinaUnknown status
The PLA 960 Hospital
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JinanChinaUnknown status
Gansu Provincal Central Hospital
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LanzhouChinaUnknown status
Liaocheng People's Hospital
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LiaochengChinaUnknown status
The Second Affiliated Hospital of Nanchang University
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NanchangChinaUnknown status
The Second Affiliated Hospital of Xinjiang Medical University
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ÜrümqiChinaUnknown status
People's Hospital of Xinjiang Uygur Autonomous Region
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ÜrümqiChinaUnknown status
Tongji Hospital
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WuhanChinaUnknown status
Xi 'an No.3 Hospital
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Xi'anChinaUnknown status
The First Affiliated Hospital of Xi'an Medical University
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Xi'anChinaUnknown status
Tangdu Hospital
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Xi'anChinaUnknown status
Department of Neurology, Xijing Hospital
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Xi'anChinaUnknown status
Shaanxi Second Provincal People's Hospital
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Xi'anChinaUnknown status
Shannxi Provincal People's Hospital
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Xi'anChinaUnknown status
Xi'an Gaoxin Hospital
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Xi’anChinaUnknown status
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaUnknown status
Xi'an Central Hospital
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Xi’anChinaUnknown status
Xianyang Hospital, Yan'an University
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XianyangChinaUnknown status
The First People's Hospital of Xianyang
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XianyangChinaUnknown status
General Hospital of Ningxia Medical University
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YinchuanChinaUnknown status
Yulin No.2 Hospital
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YulinChinaUnknown status
Yulin No.1 Hospital
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YulinChinaUnknown status
First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.