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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
  Purpose
The purpose of this academic lead study is to explore the ideal nutritional support strategy for patient with acute severe stroke.

Condition Intervention
Severe Stroke Acute Stroke Dysphagia Other: Initial enteral feeding Drug: erythromycin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: A Multi-center Randomised Controlled Trial to Explore the Ideal Initial Enteral Feeding Strategies in Patients With Severe Stroke at Acute Stage

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Death or major disability (defined by the modified Rankin scale) [ Time Frame: 3 months after onset ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 600
Study Start Date: January 2017
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Other: Initial enteral feeding Drug: erythromycin
gastrointestinal (GI) motility improving
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.
Other: Initial enteral feeding

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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): NCT02982668


Contacts
Contact: Wen Jiang, PhD 86-029-84771319 jiangwen@fmmu.edu.cn
Contact: Fang Yang, PhD 86-029-84771319 fyangx@fmmu.edu.cn

Locations
China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Fang Yuan, PhD    +86-29-84771319    yuanfang@fmmu.edu.cn   
Principal Investigator: Wen Jiang, PhD         
Tangdu Hospital Recruiting
Xi'an, Shaanxi, China, 710038
Contact: Peng Guo       1443291624@qq.com   
Principal Investigator: Wei Zhang, MD         
The First Affiliated Hospital of Xi'an Jiaotong University, Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Kang Huo, MD       huokangster@qq.com   
Principal Investigator: Kang Huo, MD         
Yulin No.2 Hospital Not yet recruiting
Yunlin, Shaanxi, China, 719000
Contact: Wenzong Wang, MD       wwz0938@126.com   
Principal Investigator: Wenzong Wang, MD         
Sponsors and Collaborators
Xijing Hospital
Tang-Du Hospital
Xi'an Central Hospital
Shaanxi Provincial People's Hospital
Hanzhong Central Hospital
Yan'an University Affiliated Hospital
Investigators
Study Director: Wen Jiang, PhD Department of Neurology, Xijing Hospital, Fourth Military Medical University
  More Information

Publications:

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02982668     History of Changes
Other Study ID Numbers: KY20162086-2
First Submitted: November 27, 2016
First Posted: December 5, 2016
Last Update Posted: November 8, 2017
Last Verified: November 2016

Keywords provided by Xijing Hospital:
severe stroke
Acute Stroke
Enteral Feeding
Mortality
Disability
Clinical trial

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action