Trial | NCT02982668  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    erythromycin ...

  • Study Participants

    306
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.
Study Started
Jan 31
2017
Primary Completion
Dec 31
2020
Study Completion
Dec 31
2020
Last Update
Nov 04
2021

Other Initial enteral feeding

Drug metoclopramide or mosapride

gastrointestinal (GI) motility improving

Full enteral feeding Active Comparator

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.

Modified full enteral feeding Experimental

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

Permissive underfeeding Experimental

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.

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 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.
No Results Posted