Optimizing Early Enteral Nutrition in Severe Stroke (OPENS)

October 31, 2021 updated by: Xijing Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

306

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital
      • Xi'an, Shaanxi, China, 710038
        • Tangdu Hospital
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University,
      • Yunlin, Shaanxi, China, 719000
        • Yulin No.2 Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Severe stroke occurred in 7 days.
  • GCS ≤12 or NIHSS≥11.
  • Any cases of profiles #3 through 5 in Water Swallowing Test or with disorder of consciousness.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 metoclopramide or mosapride everyday to improve gastrointestinal (GI) motility.
Other: Initial enteral feeding
Drug: metoclopramide or mosapride
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of patients with death or major disability (modified Rankin scale score ≥3)
Time Frame: 3 months after enrollment
modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.
3 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality (rate of patients with death)
Time Frame: 3 months after enrollment
Rate of patients with death
3 months after enrollment
The scores of National Institute of Health stroke scale
Time Frame: 7 days after enrollment
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.
7 days after enrollment
Glasgow Coma Scale
Time Frame: 7 days after enrollment
Glasgow Coma Scale, with scores ranging from 3 (no response) to 15 (normal response), was used to grade the conscious state.
7 days after enrollment
modified Rankin scale
Time Frame: 7 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.
7 days after enrollment
Barthel index
Time Frame: 7 days after enrollment
The Barthel Index is a scale, with score ranging from 0 to 100 (normal), that measures disability or dependence in activities of daily living in stroke patients
7 days after enrollment
modified Rankin scale
Time Frame: 3 months after enrollment
modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.
3 months after enrollment
Barthel index
Time Frame: 3 months after enrollment
The Barthel Index is a scale, with score ranging from 0 to 100 (normal), that measures disability or dependence in activities of daily living in stroke patients
3 months after enrollment
The incidence of treatment intolerance
Time Frame: 7 days after enrollment
The intolerance including gastric retention, diarrhea, constipation, gastrointestinal hemorrhage
7 days after enrollment
The incidence of serious adverse events
Time Frame: 3 months after enrollment
3 months after enrollment
The incidence of adverse events That are related to treatment
Time Frame: 3 months after enrollment
3 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Collaborators

Xi'an Central Hospital
First Affiliated Hospital Xi'an Jiaotong University
Tang-Du Hospital
Ankang Central Hospital
Yan'an University Affiliated Hospital
Xi'an Gaoxin Hospital
Xi'an No.3 Hospital
The First Affiliated Hospital of Xi'an Medical University
The PLA 940 hospital
Yulin No.1 Hospital
The First People's Hospital of Xianyang
Tongchuan Mining Hospital
The PLA General Hospital of Xinjiang
Tongchuan People's Hospital
Yulin No.2 Hospital

Investigators

  • Study Director: Wen Jiang, PhD, Department of Neurology, Xijing Hospital, Fourth Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

November 27, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 31, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20162086-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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