Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-05-06 @ 7:48 AM
Study NCT ID:
NCT02982668
Status:
TERMINATED
Last Update Posted:
2021-11-04
First Post:
2016-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Early Enteral Nutrition in Severe Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008787', 'term': 'Metoclopramide'}, {'id': 'C062720', 'term': 'mosapride'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D002723', 'term': 'Chlorobenzoates'}, {'id': 'D062425', 'term': 'Hydroxybenzoate Ethers'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 306}}, 'statusModule': {'whyStopped': 'Significantly higher mortality', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-31', 'studyFirstSubmitDate': '2016-11-27', 'studyFirstSubmitQcDate': '2016-11-30', 'lastUpdatePostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients with death or major disability (modified Rankin scale score ≥3)', 'timeFrame': '3 months after enrollment', 'description': 'modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.'}], 'secondaryOutcomes': [{'measure': 'Mortality (rate of patients with death)', 'timeFrame': '3 months after enrollment', 'description': 'Rate of patients with death'}, {'measure': 'The scores of National Institute of Health stroke scale', 'timeFrame': '7 days after enrollment', 'description': '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.'}, {'measure': 'Glasgow Coma Scale', 'timeFrame': '7 days after enrollment', 'description': 'Glasgow Coma Scale, with scores ranging from 3 (no response) to 15 (normal response), was used to grade the conscious state.'}, {'measure': 'modified Rankin scale', 'timeFrame': '7 days after enrollment', 'description': 'modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.'}, {'measure': 'Barthel index', 'timeFrame': '7 days after enrollment', 'description': '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'}, {'measure': 'modified Rankin scale', 'timeFrame': '3 months after enrollment', 'description': 'modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.'}, {'measure': 'Barthel index', 'timeFrame': '3 months after enrollment', 'description': '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'}, {'measure': 'The incidence of treatment intolerance', 'timeFrame': '7 days after enrollment', 'description': 'The intolerance including gastric retention, diarrhea, constipation, gastrointestinal hemorrhage'}, {'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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['severe stroke', 'Acute Stroke', 'Enteral Feeding', 'Mortality', 'Disability', 'Clinical trial'], 'conditions': ['Severe Stroke', 'Acute Stroke', 'Dysphagia']}, 'referencesModule': {'references': [{'pmid': '24289189', 'type': 'BACKGROUND', '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.'}, {'pmid': '26773077', 'type': 'BACKGROUND', '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.'}, {'pmid': '12750536', 'type': 'RESULT', '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.'}, {'pmid': '20130154', 'type': 'RESULT', '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.'}, {'pmid': '15733717', 'type': 'RESULT', '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.'}, {'pmid': '20971534', 'type': 'RESULT', '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.'}, {'pmid': '22673593', 'type': 'RESULT', '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.'}, {'pmid': '22307571', 'type': 'RESULT', '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.'}, {'pmid': '26398094', 'type': 'RESULT', '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.'}, {'pmid': '39145517', 'type': 'DERIVED', 'citation': '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': '35219379', 'type': 'DERIVED', '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.'}, {'pmid': '30755171', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this academic lead study is to explore the ideal nutritional support strategy for patient with acute severe stroke.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe stroke occurred in 7 days.\n* GCS ≤12 or NIHSS≥11.\n* Any cases of profiles #3 through 5 in Water Swallowing Test or with disorder of consciousness.\n* Plan to receive enteral feeding for at least 7 days.\n* Informed consent.\n\nExclusion Criteria:\n\n* Gastrointestinal diseases before stroke, such as gastrointestinal resection, malabsorption,and irritable bowel syndrome.\n* Brain death.\n* Complicated with the disease which only have life expectancy \\< 6 months in over 50% patients.\n* After cardiac arrest.\n* Received parenteral nutrition support.\n* Pregnant woman.\n* Concurrent severe hepatic or renal dysfunction。\n* Unstable hemodynamics.'}, 'identificationModule': {'nctId': 'NCT02982668', 'acronym': 'OPENS', 'briefTitle': 'Optimizing Early Enteral Nutrition in Severe Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'A Multi-center Randomised Controlled Trial to Explore the Ideal Initial Enteral Feeding Strategies in Patients With Severe Stroke at Acute Stage', 'orgStudyIdInfo': {'id': 'KY20162086-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Full enteral feeding', 'description': '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.', 'interventionNames': ['Other: Initial enteral feeding']}, {'type': 'EXPERIMENTAL', 'label': 'Modified full enteral feeding', 'description': 'Consistent with full enteral feeding plan, preventively add metoclopramide or mosapride everyday to improve gastrointestinal (GI) motility.', 'interventionNames': ['Other: Initial enteral feeding', 'Drug: metoclopramide or mosapride']}, {'type': 'EXPERIMENTAL', 'label': 'Permissive underfeeding', 'description': '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.', 'interventionNames': ['Other: Initial enteral feeding']}], 'interventions': [{'name': 'Initial enteral feeding', 'type': 'OTHER', 'armGroupLabels': ['Full enteral feeding', 'Modified full enteral feeding', 'Permissive underfeeding']}, {'name': 'metoclopramide or mosapride', 'type': 'DRUG', 'description': 'gastrointestinal (GI) motility improving', 'armGroupLabels': ['Modified full enteral feeding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '710038', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Tangdu Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': "The First Affiliated Hospital of Xi'an Jiaotong University,", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '719000', 'city': 'Yunlin', 'state': 'Shaanxi', 'country': 'China', 'facility': 'Yulin No.2 Hospital'}], 'overallOfficials': [{'name': 'Wen Jiang, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Neurology, Xijing Hospital, Fourth Military Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tang-Du Hospital', 'class': 'OTHER'}, {'name': "Xi'an Central Hospital", 'class': 'OTHER'}, {'name': "Xi'an Gaoxin Hospital", 'class': 'OTHER'}, {'name': "Yan'an University Affiliated Hospital", 'class': 'OTHER'}, {'name': "940 Hospital of the People's Liberation Army Joint Logistic Support Force", 'class': 'OTHER'}, {'name': "Xi'an No.3 Hospital", 'class': 'OTHER_GOV'}, {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, {'name': 'Yulin No.1 Hospital', 'class': 'UNKNOWN'}, {'name': "First People's Hospital of Xianyang", 'class': 'OTHER'}, {'name': 'Tongchuan Mining Hospital', 'class': 'UNKNOWN'}, {'name': 'The PLA General Hospital of Xinjiang', 'class': 'UNKNOWN'}, {'name': "Tongchuan People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Yulin No.2 Hospital', 'class': 'OTHER'}, {'name': 'Ankang Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}