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NCT Number: NCT05998902

Optimizing Early Nutrition Support in Severe Stroke-2

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.

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Key information

Conditions

Severe Stroke Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Infections Lung Diseases Nervous System Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chongqing University Three Gorges Hospital, Chongqing, Chongqing Municipality, China

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About this study

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 and hospital mortality and poorer functional outcomes in survivors. The peak period of PSP is within the first week after stroke. Aspiration and poor nutritional status are important factors leading to pneumonia in stroke patients. Compared with full enteral nutrition (EN), initial trophic enteral feeding was associated with less gastrointestinal intolerance and could reduce the rate of regurgitation. However, trophic enteral feeding could not meet the daily caloric needs and hypocaloric enteral nutrition might be associated with increased mortality. This study is designed to explore whether initial trophic enteral nutrition combined with supplemental parenteral nutrition (SPN) can help reduce the incidence of PSP and improve the prognosis in severe patients with stroke.

This study will enroll 546 severe stroke patients who meet the inclusion criteria. Upon admission to the ICU, patients will be randomly assigned at a 1:1 ratio into groups of full enteral feeding (controlled) and trophic enteral feeding combined with supplemental parenteral feeding (experimented) for 7 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Trophic enteral feeding combined with supplemental parenteral nutrition

Procedure

The caloric goal of the first day is one-third of caloric requirements, the second day is half of caloric requirements, the third day is 70-100% and sustained for 1 week. Patients will receive the trophic enteral feeding with a caloric target of 500kcal/d (20-35ml/h), and the remaining calories are supplemented by parenteral nutrition. Protein requirements are calculated at 1.2 to 1.5 g per kilogram of body weight per day.

Full enteral feeding

Procedure

The caloric goal of the first day is one-third of caloric requirements, the second day is half of caloric requirements, the third day is 70-100% and sustained for 1 week. Protein requirements are calculated at 1.2 to 1.5 g per kilogram of body weight per day. Enteral nutrition is given through nasogastric tube or nasointestinal tube.

Primary outcomes

  1. Incidence of post stroke pneumonia

    Time frame: up to 7 days

Secondary outcomes

  1. The time from randomisation to the onset of the post stroke pneumonia

    Time frame: up to 7 days

  2. Daily calorie delivery

    Time frame: up to 7 days

  3. Daily protein delivery

    Time frame: up to 7 days

  4. Insulin utilization

    Time frame: up to 7 days

    Insulin utilization during the first 7 days post-randomization

  5. The incidence of gastrointestinal complications

    Time frame: up to 7 days

    Vomiting, diarrhea, gastric retention, gastrointestinal bleeding

  6. The use of prokinetic agents

    Time frame: up to 7 days

    The usage rate of prokinetic agents

  7. The occurrence of infections

    Time frame: 1 day of ICU discharge

    The rate and onset time of infections from randomisation to ICU discharge

  8. The length of ICU stay

    Time frame: 1 day of ICU discharge

  9. Mortality

    Time frame: 1 day of ICU discharge

    from randomisation to all cause death during ICU stay.

  10. The All-cause mortality rate

    Time frame: 28 days after enrollment

    from randomisation to all cause death at 28 days

  11. Cardiac failure

    Time frame: 1 day of ICU discharge

    The incidence of cardiac failure from randomisation to ICU discharge

  12. Tracheotomy

    Time frame: 1 day of ICU discharge

    The incidence of tracheotomy from randomisation to ICU discharge

  13. Mechanical ventilation

    Time frame: 1 day of ICU discharge

    The incidence of mechanical ventilation from randomisation to ICU discharge

  14. Continuous renal replacement therapy

    Time frame: 1 day of ICU discharge

    The incidence of continuous renal replacement therapy from randomisation to ICU discharge

  15. The use of vasoactive agents

    Time frame: 1 day of ICU discharge

    The usage rate of vasoactive agents from randomisation to ICU discharge

  16. Deep venous thrombosis

    Time frame: 1 day of ICU discharge

    The incidence of deep venous thrombosis from randomisation to ICU discharge

  17. The score of National Institute of Health stroke scale at ICU discharge

    Time frame: 1 day of ICU discharge

    National Institute of Health stroke scale, with scores ranging from 0 (normal function) to 42 (functional impairment) was used to evaluate the impairment caused by a stroke.

  18. Glasgow Coma Scale at ICU discharge

    Time frame: 1 day of ICU discharge

    Glasgow Coma Scale,with scores ranging from 3 (no response) to 15 (normal response), was used to grade the conscious state.

  19. modified Rankin scale at ICU discharge

    Time frame: 1 day of ICU discharge

    modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.

  20. modified Rankin scale

    Time frame: 90 days after enrollment

    modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke, including ordinal mRS, excellent outcome (mRS 0-1), and functional independence (mRS 0-2)

Other outcomes

  1. Composite endpoint of all-cause mortality and post-stroke pneumonia

    Time frame: 90 days after randomization

    Hierarchical composite endpoint of all-cause mortality and post-stroke pneumonia within 90 days

  2. Composite endpoint of all-cause mortality and post-stroke pneumonia

    Time frame: 7 days after randomization

    Hierarchical composite endpoint of all-cause mortality and post-stroke pneumonia within 7 days

  3. Time from randomization to the first occurrence of either all-cause death or post-stroke pneumonia

    Time frame: 90 days after randomization

    Time from randomization to the first occurrence of either all-cause death or post-stroke pneumonia within 90 days

Sponsors and collaborators

Lead sponsor

Wen Jiang-3

Other

Collaborators

  • Daping Hospital of Army Medical University
  • First Affiliated Hospital Xi'an Jiaotong University
  • First Hospital Affiliated to Zhengzhou University
  • First People's Hospital of Xianyang
  • Gansu Provincial Central Hospital
  • Nanfang Hospital, Southern Medical University
  • PLA 960 Hospital
  • Qilu Hospital of Shandong University
  • Shaanxi Provincial People's Hospital
  • Tang-Du Hospital
  • The First Hospital of Changsha City
  • The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
  • The Second Hospital of Shandong University
  • Tongji Hospital
  • Xi'an Central Hospital
  • Xi'an Gaoxin Hospital
  • Xi'an No.3 Hospital
  • Xijing Hospital
  • Yulin No.1 Hospital
  • Yulin No.2 Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2023
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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