Optimizing Early Enteral Nutrition in Severe Stroke (OPENS)

A Multi-center Randomised Controlled Trial to Explore the Ideal Initial Enteral Feeding Strategies in Patients With Severe Stroke at Acute Stage

Tang-Du Hospital, Xi'an Central Hospital, Xi'an Gaoxin Hospital, Yan'an University Affiliated Hospital, The PLA 940 hospital, Xi'an No.3 Hospital, The First Affiliated Hospital of Xi'an Medical University, 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, First Affiliated Hospital Xi'an Jiaotong University, Ankang Central Hospital

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.

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.

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

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.

modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.

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, with scores ranging from 3 (no response) to 15 (normal response), was used to grade the conscious state.

modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.

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 score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.

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

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.

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Zhao J, Yuan F, Song C, Yin R, Chang M, Zhang W, Zhang B, Yu L, Jia Y, Ma Y, Song Y, Wang C, Song C, Wang X, Shang L, Yang F, Jiang W; OPENS Trial Investigators. Safety and efficacy of three enteral feeding strategies in patients with severe stroke in China (OPENS): a multicentre, prospective, randomised, open-label, blinded-endpoint trial. Lancet Neurol. 2022 Apr;21(4):319-328. doi: 10.1016/S1474-4422(22)00010-2. Epub 2022 Feb 24.

Yuan F, Yang F, Zhang W, Jia Y, Ma Y, Qu Y, Wang X, Huo K, Wang C, Yuan X, Song C, Zhang B, Jiang W; OPENS study group. Optimizing early enteral nutrition in severe stroke (OPENS): protocol for a multicentre randomized controlled trial. BMC Neurol. 2019 Feb 12;19(1):24. doi: 10.1186/s12883-019-1253-2.