Optimizing Early Nutrition Support in Severe Stroke-2

Sponsor
Wen Jiang-3 (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05998902
Collaborator
Tang-Du Hospital (Other), Xi'an Central Hospital (Other), Xi'an Gaoxin Hospital (Other), First Affiliated Hospital of Xi'an Medical University (Other), Xi'an No.3 Hospital (Other), First People's Hospital of Xianyang (Other), Nanfang Hospital, Southern Medical University (Other), Tongji Hospital (Other), Qilu Hospital of Shandong University (Other), The Second Hospital of Shandong University (Other), PLA 960 Hospital (Other), Daping Hospital, The Third Military Medical University (Army Medical University) (Other), The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Other), First Hospital Affiliated to Zhengzhou University (Other), Gansu Provincial Central Hospital (Other), The First Hospital of Changsha City (Other), Shaanxi Provincial People's Hospital (Other), Yulin No.2 Hospital (Other), Yulin No.1 Hospital (Other), Xijing Hospital (Other)
546
20
2
38.6
27.3
0.7

Study Details

Study Description

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
  • 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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Aug 14, 2023
Anticipated Primary Completion Date :
Jul 31, 2026
Anticipated Study Completion Date :
Oct 31, 2026

Arms and Interventions

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

Primary Outcome Measures

  1. Incidence of post stroke pneumonia [up to 7 days]

Secondary Outcome Measures

  1. The time from randomisation to the onset of the post stroke pneumonia [up to 7 days]

  2. Daily calorie delivery [up to 7 days]

  3. Daily protein delivery [up to 7 days]

  4. Insulin dosage [up to 7 days]

  5. The incidence of gastrointestinal complications [up to 7 days]

    Vomiting, diarrhea, gastric retention, gastrointestinal bleeding

  6. The use of prokinetic agents [up to 7 days]

    The usage rate of prokinetic agents

  7. The occurrence of infections [1 day of ICU discharge]

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

  8. The length of ICU stay [1 day of ICU discharge]

  9. Mortality [1 day of ICU discharge]

    from randomisation to all cause death during ICU stay.

  10. The All-cause mortality rate [28 days after enrollment]

    from randomisation to all cause death at 28 days

  11. Cardiac failure [1 day of ICU discharge]

    The incidence of cardiac failure from randomisation to ICU discharge

  12. Tracheotomy [1 day of ICU discharge]

    The incidence of tracheotomy from randomisation to ICU discharge

  13. Mechanical ventilation [1 day of ICU discharge]

    The incidence of mechanical ventilation from randomisation to ICU discharge

  14. Continuous renal replacement therapy [1 day of ICU discharge]

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

  15. The use of vasoactive agents [1 day of ICU discharge]

    The usage rate of vasoactive agents from randomisation to ICU discharge

  16. Deep venous thrombosis [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 [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 [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 [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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Daping Hospital, The Third Military Medical University Chongqing Chongqing China
2 Gansu Provincal Central Hospital Lanzhou Gansu China
3 Nanfang Hospital, Southern Medical University Guangzhou Guangdong China
4 The Second Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou Guangdong China
5 First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China
6 Tongji Hospital Wuhan Hubei China
7 The First Hospital of Changsha City Changsha Hunan China
8 Tangdu Hospital Xi'an Shaanxi China 710000
9 Xi'an Central Hospital Xi'an Shaanxi China 710000
10 Department of Neurology, Xijing Hospital Xi'an Shaanxi China
11 Shannxi Provincal People's Hospital Xi'an Shaanxi China
12 The First Affiliated Hospital of Xi'an Medical University Xi'an Shaanxi China
13 Xi'an Gaoxin Hospital Xi'an Shaanxi China
14 Xi'an No.3 Hospital Xi'an Shaanxi China
15 The First People's Hospital of Xianyang Xianyang Shaanxi China
16 Yulin No.1 Hospital Yulin Shaanxi China
17 Yulin No.2 Hospital Yulin Shaanxi China
18 Qilu Hospital of Shangdong University Jinan Shandong China
19 The PLA 960 Hospital Jinan Shandong China
20 The Second Hospital of Shandong University Jinan Shandong China

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Wen Jiang-3, Head of Neurology, Xijing Hospital
ClinicalTrials.gov Identifier:
NCT05998902
Other Study ID Numbers:
  • XJLL-KY-20222214
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wen Jiang-3, Head of Neurology, Xijing Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2023