Clinical trial NCT02982668: Optimizing Early Enteral Nutrition in Severe Stroke
Official title: A Multi-center Randomised Controlled Trial to Explore the Ideal Initial Enteral Feeding Strategies in Patients With Severe Stroke at Acute Stage
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Severe Stroke
Acute Stroke
Dysphagia
Keywords: severe stroke
Acute Stroke
Enteral Feeding
Mortality
Disability
Clinical trial
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Tang-Du Hospital
name: Xi'an Central Hospital
name: Xi'an Gaoxin Hospital
name: Yan'an University Affiliated Hospital
name: 940 Hospital of the People's Liberation Army Joint Logistic Support Force
name: Xi'an No.3 Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: Yulin No.1 Hospital
name: First People's Hospital of Xianyang
name: Tongchuan Mining Hospital
name: The PLA General Hospital of Xinjiang
name: Tongchuan People's Hospital
name: Yulin No.2 Hospital
name: Ankang Central Hospital
First posted: 2016-12-05
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility 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.

Primary outcomes:
measure: Rate of patients with death or major disability (modified Rankin scale score ≥3)
timeFrame: 3 months after enrollment
Secondary outcomes:
measure: Mortality (rate of patients with death)
timeFrame: 3 months after enrollment
measure: The scores of National Institute of Health stroke scale
timeFrame: 7 days after enrollment
measure: Glasgow Coma Scale
timeFrame: 7 days after enrollment
measure: modified Rankin scale
timeFrame: 7 days after enrollment
measure: Barthel index
timeFrame: 7 days after enrollment
measure: modified Rankin scale
timeFrame: 3 months after enrollment
measure: Barthel index
timeFrame: 3 months after enrollment
measure: The incidence of treatment intolerance
timeFrame: 7 days after enrollment
measure: The incidence of serious adverse events
timeFrame: 3 months after enrollment
measure: The incidence of adverse events That are related to treatment
timeFrame: 3 months after enrollment
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University,
state: Shaanxi
city: Yunlin
country: China
facility: Yulin No.2 Hospital
state: Shaanxi
Study officials:
affiliation: Department of Neurology, Xijing Hospital, Fourth Military Medical University
name: Wen Jiang, PhD
role: STUDY_DIRECTOR
References:
citation: Wirth R, Smoliner C, Jager M, Warnecke T, Leischker AH, Dziewas R; DGEM Steering Committee*. Guideline clinical nutrition in patients with stroke. Exp Transl Stroke Med. 2013 Dec 1;5(1):14. doi: 10.1186/2040-7378-5-14.
citation: McClave SA, Taylor BE, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C; Society of Critical Care Medicine; American Society for Parenteral and Enteral Nutrition. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):159-211. doi: 10.1177/0148607115621863. No abstract available.
citation: FOOD Trial Collaboration. Poor nutritional status on admission predicts poor outcomes after stroke: observational data from the FOOD trial. Stroke. 2003 Jun;34(6):1450-6. doi: 10.1161/01.STR.0000074037.49197.8C. Epub 2003 May 15.
citation: Ukleja A. Altered GI motility in critically Ill patients: current understanding of pathophysiology, clinical impact, and diagnostic approach. Nutr Clin Pract. 2010 Feb;25(1):16-25. doi: 10.1177/0884533609357568.
citation: Dennis MS, Lewis SC, Warlow C; FOOD Trial Collaboration. Effect of timing and method of enteral tube feeding for dysphagic stroke patients (FOOD): a multicentre randomised controlled trial. Lancet. 2005 Feb 26-Mar 4;365(9461):764-72. doi: 10.1016/S0140-6736(05)17983-5.
citation: Heyland DK, Stephens KE, Day AG, McClave SA. The success of enteral nutrition and ICU-acquired infections: a multicenter observational study. Clin Nutr. 2011 Apr;30(2):148-55. doi: 10.1016/j.clnu.2010.09.011. Epub 2010 Oct 25.
citation: Jie B, Jiang ZM, Nolan MT, Zhu SN, Yu K, Kondrup J. Impact of preoperative nutritional support on clinical outcome in abdominal surgical patients at nutritional risk. Nutrition. 2012 Oct;28(10):1022-7. doi: 10.1016/j.nut.2012.01.017. Epub 2012 Jun 5.
citation: National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Rice TW, Wheeler AP, Thompson BT, Steingrub J, Hite RD, Moss M, Morris A, Dong N, Rock P. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012 Feb 22;307(8):795-803. doi: 10.1001/jama.2012.137. Epub 2012 Feb 5.
citation: Permissive Underfeeding or Standard Enteral Feeding in Critically Ill Adults. N Engl J Med. 2015 Sep 24;373(13):1281. doi: 10.1056/NEJMx150028. No abstract available.
citation: 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.
citation: 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.