Optimizing Early Enteral Nutrition in Severe Stroke

Dysphagia Clinical Trial

— OPENS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02982668
• Other study ID #: KY20162086-2
• Status: Terminated
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2020

Study information

• Verified date: December 2020
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 306
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Stroke
• Dysphagia
• Severe Stroke
• Stroke

Intervention

Other:
• Initial enteral feeding

Drug:
• metoclopramide or mosapride
gastrointestinal (GI) motility improving

Locations

Country	Name	City	State
China	Tangdu Hospital	Xi'an	Shaanxi
China	The First Affiliated Hospital of Xi'an Jiaotong University,	Xi'an	Shaanxi
China	Xijing Hospital	Xi'an	Shaanxi
China	Yulin No.2 Hospital	Yunlin	Shaanxi

Sponsors (16)

Lead Sponsor

Collaborator

Xijing Hospital

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

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View 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. Epub 2003 May 15. — View 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. — View 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. — View 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. Erratum in: JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1200. — View 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 wit — View 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. — View 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. Review. — View Citation

Wirth R, Smoliner C, Jäger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with death or major disability (modified Rankin scale score =3)	modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.	3 months after enrollment
Secondary	Mortality (rate of patients with death)	Rate of patients with death	3 months after enrollment
Secondary	The scores of National Institute of Health stroke scale	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.	7 days after enrollment
Secondary	Glasgow Coma Scale	Glasgow Coma Scale, with scores ranging from 3 (no response) to 15 (normal response), was used to grade the conscious state.	7 days after enrollment
Secondary	modified Rankin scale	modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.	7 days after enrollment
Secondary	Barthel index	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	7 days after enrollment
Secondary	modified Rankin scale	modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.	3 months after enrollment
Secondary	Barthel index	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	3 months after enrollment
Secondary	The incidence of treatment intolerance	The intolerance including gastric retention, diarrhea, constipation, gastrointestinal hemorrhage	7 days after enrollment
Secondary	The incidence of serious adverse events		3 months after enrollment
Secondary	The incidence of adverse events That are related to treatment		3 months after enrollment