OPENS: Optimizing Early Enteral Nutrition in Severe Stroke

Sponsor

Xijing Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT02982668

Collaborator

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

306

Enrollment

Locations

Arms

Actual Duration (Months)

76.5

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Severe Stroke Acute Stroke Dysphagia	Other: Initial enteral feeding Drug: metoclopramide or mosapride	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

306 participants

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Dec 1, 2020

Actual Study Completion Date :

Dec 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Rate of patients with death or major disability (modified Rankin scale score ≥3) [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.

Secondary Outcome Measures

Mortality (rate of patients with death) [3 months after enrollment]
Rate of patients with death
The scores of National Institute of Health stroke scale [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.
Glasgow Coma Scale [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.
modified Rankin scale [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.
Barthel index [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
modified Rankin scale [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.
Barthel index [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
The incidence of treatment intolerance [7 days after enrollment]
The intolerance including gastric retention, diarrhea, constipation, gastrointestinal hemorrhage
The incidence of serious adverse events [3 months after enrollment]
The incidence of adverse events That are related to treatment [3 months after enrollment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xijing Hospital	Xi'an	Shaanxi	China	710032
2	Tangdu Hospital	Xi'an	Shaanxi	China	710038
3	The First Affiliated Hospital of Xi'an Jiaotong University,	Xi'an	Shaanxi	China	710061
4	Yulin No.2 Hospital	Yunlin	Shaanxi	China	719000