NCT02982668

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
306

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 4, 2021

Status Verified

December 1, 2020

Enrollment Period

3.9 years

First QC Date

November 27, 2016

Last Update Submit

October 31, 2021

Conditions

Severe StrokeAcute StrokeDysphagia

Keywords

severe strokeAcute StrokeEnteral FeedingMortalityDisabilityClinical trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Mortality (rate of patients with death)

    3 months after enrollment

  • The scores of National Institute of Health stroke scale

    7 days after enrollment

  • Glasgow Coma Scale

    7 days after enrollment

  • modified Rankin scale

    7 days after enrollment

  • Barthel index

    7 days after enrollment

  • +5 more secondary outcomes

Study Arms (3)

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.

Other: Initial enteral feeding

Modified full enteral feeding

EXPERIMENTAL

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

Other: Initial enteral feedingDrug: metoclopramide or mosapride

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.

Other: Initial enteral feeding

Interventions

Initial enteral feedingOTHER
Full enteral feedingModified full enteral feedingPermissive underfeeding
metoclopramide or mosaprideDRUG

gastrointestinal (GI) motility improving

Modified full enteral feeding

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Tangdu Hospital

Xi'an, Shaanxi, 710038, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University,

Xi'an, Shaanxi, 710061, China

Location

Yulin No.2 Hospital

Yunlin, Shaanxi, 719000, China

Location

Related Publications (12)

  • 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.

    PMID: 24289189BACKGROUND

  • 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.

    PMID: 26773077BACKGROUND

  • 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.

    PMID: 12750536RESULT

  • 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.

    PMID: 20130154RESULT

  • 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.

    PMID: 15733717RESULT

  • 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.

    PMID: 20971534RESULT

  • 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.

    PMID: 22673593RESULT

  • 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.

    PMID: 22307571RESULT

  • 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.

    PMID: 26398094RESULT

  • Sakai K, Niimi M, Momosaki R, Hoshino E, Yoneoka D, Nakayama E, Masuoka K, Maeda T, Takahashi N, Sakata N. Nutritional therapy for reducing disability and improving activities of daily living in people after stroke. Cochrane Database Syst Rev. 2024 Aug 15;8(8):CD014852. doi: 10.1002/14651858.CD014852.pub2.

    PMID: 39145517DERIVED

  • 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.

    PMID: 35219379DERIVED

  • 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.

    PMID: 30755171DERIVED

MeSH Terms

Conditions

StrokeDeglutition Disorders

Interventions

Metoclopramidemosapride

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenols

Study Officials

  • Wen Jiang, PhD

    Department of Neurology, Xijing Hospital, Fourth Military Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2016

First Posted

December 5, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

November 4, 2021

Record last verified: 2020-12

Locations

CN(4)