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Optimizing Early Enteral Nutrition in Severe Stroke (OPENS)

This study is currently recruiting participants.
Verified November 2016 by Xijing Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02982668
First Posted: December 5, 2016
Last Update Posted: November 8, 2017
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.
Collaborators:
Tang-Du Hospital
Xi'an Central Hospital
Shaanxi Provincial People's Hospital
Hanzhong Central Hospital
Yan'an University Affiliated Hospital
Information provided by (Responsible Party):
Xijing Hospital
November 27, 2016
December 5, 2016
November 8, 2017
January 2017
December 2022   (Final data collection date for primary outcome measure)
Death or major disability (defined by the modified Rankin scale) [ Time Frame: 3 months after onset ]
Same as current
Complete list of historical versions of study NCT02982668 on ClinicalTrials.gov Archive Site
  • Death or major disability (defined by the modified Rankin scale) [ Time Frame: 14 days after onset ]
  • National Institute of Health stroke scale [ Time Frame: 14 days after onset ]
  • National Institute of Health stroke scale [ Time Frame: 3 months after onset ]
  • Symptomatic hypotension [ Time Frame: 7 days ]
  • Renal failure [ Time Frame: 7 days ]
  • Blood coagulation disorder [ Time Frame: 7 days ]
  • Adverse Events That Are Related to Treatment [ Time Frame: 7 days ]
Same as current
Not Provided
Not Provided
 
Optimizing Early Enteral Nutrition in Severe Stroke
A Multi-center Randomised Controlled Trial to Explore the Ideal Initial Enteral Feeding Strategies in Patients With Severe Stroke at Acute Stage
The purpose of this academic lead study is to explore the ideal nutritional support strategy for patient with acute severe stroke.

Of high mortality and morbidity, severe stroke is associated with devastating damages in neurologic, respiratory, circulatory and many other systems. The outcomes of patients with severe stroke depend largely on medical strategies on acute stage, especially on nutritional support management. Unfortunately, clinical evidence are sparse and the ideal initial feeding strategy remains disputable.

The IF-STROKE study aims to provide reliable data on the effects of modified full enteral feeding (target recruitment 200) and permissive underfeeding in patients with acute severe stroke (target recruitment 200) compared to full enteral feeding (target recruitment 200). Patients presenting with acute (<72h) severe stroke (GCS ≦ 12 or NIHSS ≧ 11) and dysphagia (defined by Water Swallowing Test) will be randomly assigned to full enteral feeding, modified full enteral feeding, or permissive underfeeding treatment for 7 days.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
  • Severe Stroke
  • Acute Stroke
  • Dysphagia
  • Other: Initial enteral feeding
  • Drug: erythromycin
    gastrointestinal (GI) motility improving
  • Active Comparator: 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.
    Intervention: Other: Initial enteral feeding
  • Experimental: Modified full enteral feeding
    Consistent with full enteral feeding plan, preventively add erythromycin or mosapride everyday to improve gastrointestinal (GI) motility.
    Interventions:
    • Other: Initial enteral feeding
    • Drug: erythromycin
  • Experimental: Permissive underfeeding
    The caloric goal of the first day is one-third of caloric requirements, the second day is 40-60% and sustained for 1 week. Protein requirements are calculated at 1.2 to 1.5 g per kilogram of body weight per day.
    Intervention: Other: Initial enteral feeding

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
December 2022
December 2022   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Severe stroke occurred in 7 days.
  • GCS ≤12 or NIHSS≥11.
  • Any cases of profiles #3 through 5 in Water Swallowing Test.
  • Plan to receive enteral feeding for at least 7 days.
  • Informed consent.

Exclusion Criteria:

  • Gastrointestinal diseases before stroke, such as gastrointestinal resection, malabsorption,and irritable bowel syndrome.
  • Brain death.
  • Complicated with the disease which only have life expectancy < 6 months in over 50% patients.
  • After cardiac arrest.
  • Received parenteral nutrition support.
  • Pregnant woman.
  • Concurrent severe hepatic or renal dysfunction。
  • Unstable hemodynamics.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Wen Jiang, PhD 86-029-84771319 jiangwen@fmmu.edu.cn
Contact: Fang Yang, PhD 86-029-84771319 fyangx@fmmu.edu.cn
China
 
 
NCT02982668
KY20162086-2
Yes
Not Provided
Not Provided
Xijing Hospital
Xijing Hospital
  • Tang-Du Hospital
  • Xi'an Central Hospital
  • Shaanxi Provincial People's Hospital
  • Hanzhong Central Hospital
  • Yan'an University Affiliated Hospital
Study Director: Wen Jiang, PhD Department of Neurology, Xijing Hospital, Fourth Military Medical University
Xijing Hospital
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP