Optimizing Early Enteral Nutrition in Severe Stroke (OPENS)

Air Force Military Medical University of People's Liberation Army

Status: Terminated

Conditions: Severe Stroke; Dysphagia; Acute Stroke

Treatments: Other: Initial enteral feeding; Drug: metoclopramide or mosapride

Study type: Interventional

Funder types: Other

Identifiers

NCT02982668

KY20162086-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 306 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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306 participants in 3 patient groups

Full enteral feeding

Active Comparator group

Description:

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.

Treatment:

Other: Initial enteral feeding

Modified full enteral feeding

Experimental group

Description:

Consistent with full enteral feeding plan, preventively add metoclopramide or mosapride everyday to improve gastrointestinal (GI) motility.

Treatment:

Drug: metoclopramide or mosapride

Other: Initial enteral feeding

Permissive underfeeding

Experimental group

Description:

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.

Treatment:

Other: Initial enteral feeding