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Optimizing Early Nutrition Support in Severe Stroke-2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05998902
Recruitment Status : Recruiting
First Posted : August 21, 2023
Last Update Posted : March 29, 2024
Sponsor:
Collaborators:
Tang-Du Hospital
Xi'an Central Hospital
Xi'an Gaoxin Hospital
First Affiliated Hospital of Xi'an Medical University
Xi'an No.3 Hospital
First People's Hospital of Xianyang
Nanfang Hospital, Southern Medical University
Tongji Hospital
Qilu Hospital of Shandong University
The Second Hospital of Shandong University
PLA 960 Hospital
Daping Hospital, The Third Military Medical University (Army Medical University)
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
First Hospital Affiliated to Zhengzhou University
Gansu Provincial Central Hospital
The First Hospital of Changsha City
Shaanxi Provincial People's Hospital
Yulin No.2 Hospital
Yulin No.1 Hospital
Xijing Hospital
Information provided by (Responsible Party):
Wen Jiang-3, Xijing Hospital

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Severe Stroke Acute Stroke Dysphagia Procedure: Trophic enteral feeding combined with supplemental parenteral nutrition Procedure: Full enteral feeding Phase 3

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 546 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official 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
Actual Study Start Date : December 20, 2023
Estimated Primary Completion Date : July 31, 2026
Estimated Study Completion Date : October 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Full enteral feeding
Patients will receive full enteral feeding through nasogastric tube or nasointestinal tube.
 Procedure: Full enteral feeding
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.
Experimental: Trophic enteral feeding combined with supplemental parenteral nutrition
Patients will receive trophic enteral feeding combined with supplemental parenteral feeding.
 Procedure: Trophic enteral feeding combined with supplemental parenteral nutrition
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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of post stroke pneumonia [ Time Frame: up to 7 days ]

Secondary Outcome Measures :
  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 dosage [ Time Frame: up to 7 days ]
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05998902


Contacts
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Contact: Wen Jiang, Ph.D 86-029-84771319 jiangwen@fmmu.edu.cn
Contact: Xuan Wang, MD 86-029-84773664 786369892@qq.com

Locations
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Sponsors and Collaborators
Wen Jiang-3
Tang-Du Hospital
Xi'an Central Hospital
Xi'an Gaoxin Hospital
First Affiliated Hospital of Xi'an Medical University
Xi'an No.3 Hospital
First People's Hospital of Xianyang
Nanfang Hospital, Southern Medical University
Tongji Hospital
Qilu Hospital of Shandong University
The Second Hospital of Shandong University
PLA 960 Hospital
Daping Hospital, The Third Military Medical University (Army Medical University)
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
First Hospital Affiliated to Zhengzhou University
Gansu Provincial Central Hospital
The First Hospital of Changsha City
Shaanxi Provincial People's Hospital
Yulin No.2 Hospital
Yulin No.1 Hospital
Xijing Hospital
More Information
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Publications:
Reignier J, Boisrame-Helms J, Brisard L, Lascarrou JB, Ait Hssain A, Anguel N, Argaud L, Asehnoune K, Asfar P, Bellec F, Botoc V, Bretagnol A, Bui HN, Canet E, Da Silva D, Darmon M, Das V, Devaquet J, Djibre M, Ganster F, Garrouste-Orgeas M, Gaudry S, Gontier O, Guerin C, Guidet B, Guitton C, Herbrecht JE, Lacherade JC, Letocart P, Martino F, Maxime V, Mercier E, Mira JP, Nseir S, Piton G, Quenot JP, Richecoeur J, Rigaud JP, Robert R, Rolin N, Schwebel C, Sirodot M, Tinturier F, Thevenin D, Giraudeau B, Le Gouge A; NUTRIREA-2 Trial Investigators; Clinical Research in Intensive Care and Sepsis (CRICS) group. Enteral versus parenteral early nutrition in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2). Lancet. 2018 Jan 13;391(10116):133-143. doi: 10.1016/S0140-6736(17)32146-3. Epub 2017 Nov 8.

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Responsible Party: Wen Jiang-3, Head of Neurology, Xijing Hospital
ClinicalTrials.gov Identifier: NCT05998902    
Other Study ID Numbers: XJLL-KY-20222214
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: March 29, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wen Jiang-3, Xijing Hospital:
Severe Stroke
Acute Stroke
Dysphagia
 supplemental parenteral nutrition
trophic feeding
pneumonia
Additional relevant MeSH terms:
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Deglutition Disorders
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
 Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases