Severe StrokeOPENSNCT02982668

Optimizing Early Enteral Nutrition in Severe Stroke

A study testing Initial enteral feeding and metoclopramide or mosapride in people with Severe Stroke and Acute Stroke, run by Xijing Hospital at 4 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Severe Stroke, Acute Stroke, Dysphagia
What is being tested?: Initial enteral feeding and metoclopramide or mosapride
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 306 participants
Where: 4 sitesChina
Study dates: Jan 2017to Dec 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

4 sites in 1 country.

China4 sites

Xijing Hospital
Xi'an, Shaanxi, 710032
Tangdu Hospital
Xi'an, Shaanxi, 710038
The First Affiliated Hospital of Xi'an Jiaotong University,
Xi'an, Shaanxi, 710061
Yulin No.2 Hospital
Yunlin, Shaanxi, 719000

Other trials in China

About this study

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

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

Read the 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.

Conditions: Severe Stroke, Acute Stroke, Dysphagia
Being tested: Initial enteral feeding, metoclopramide or mosapride
Keywords: severe stroke, Acute Stroke, Enteral Feeding, Mortality, Disability, Clinical trial
Medical subject headings: Stroke, Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Initial enteral feedingOther
metoclopramide or mosaprideDrug
gastrointestinal (GI) motility improving

Study groups in NCT02982668
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Initial enteral feeding; Drug: 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. Receives: Other: Initial enteral feeding

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 months after enrollment

Secondary outcomes (10)

Mortality (rate of patients with death)
Rate of patients with death
Measured: 3 months after enrollment
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.
Measured: 7 days after enrollment
Glasgow Coma Scale
Glasgow Coma Scale, with scores ranging from 3 (no response) to 15 (normal response), was used to grade the conscious state.
Measured: 7 days after enrollment
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.
Measured: 7 days after enrollment
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
Measured: 7 days after enrollment
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.
Measured: 3 months after enrollment
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
Measured: 3 months after enrollment
The incidence of treatment intolerance
The intolerance including gastric retention, diarrhea, constipation, gastrointestinal hemorrhage
Measured: 7 days after enrollment
The incidence of serious adverse events
Measured: 3 months after enrollment
The incidence of adverse events That are related to treatment
Measured: 3 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2017Dec 2020

First posted5 Dec 2016 (estimated)
Study startJan 2017
Primary completionDec 2020
Study completionDec 2020

Why it stopped: Significantly higher mortality

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Severe StrokeStudies of the same condition, open and under way.
More trials run by Xijing HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 306 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02982668
Sponsor's protocol ID: KY20162086-2
Acronym: OPENS
Status last verified: Dec 2020
First submitted: 27 Nov 2016
Last updated: 4 Nov 2021
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 24289189
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.
PubMed 26773077
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.
PubMed 12750536
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.
PubMed 20130154
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.
PubMed 15733717
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.
PubMed 20971534
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.
PubMed 22673593
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.
PubMed 22307571
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.
PubMed 26398094
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.
PubMed 39145517
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.
PubMed 35219379
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.
PubMed 30755171

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Severe Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center Randomised Controlled Trial to Explore the Ideal Initial Enteral Feeding Strategies in Patients With Severe Stroke at Acute Stage
ClinicalTrials.gov ID: NCT02982668
Acronym / sponsor ID: OPENS / KY20162086-2
Conditions: Severe Stroke, Acute Stroke, Dysphagia
Keywords: severe stroke, Acute Stroke, Enteral Feeding, Mortality, Disability, Clinical trial
Study type: Interventional
Recruitment status: TerminatedReason stopped: Significantly higher mortality
Enrolment: 306 participants (actual)
Lead sponsor: Xijing HospitalUniversity, hospital or other
Collaborators: Tang-Du Hospital, Xi'an Central Hospital, Xi'an Gaoxin Hospital, Yan'an University Affiliated Hospital, 940 Hospital of the People's Liberation Army Joint Logistic Support Force, Xi'an No.3 Hospital, First Affiliated Hospital Xi'an Jiaotong University, Yulin No.1 Hospital, First People's Hospital of Xianyang, Tongchuan Mining Hospital, The PLA General Hospital of Xinjiang, Tongchuan People's Hospital, Yulin No.2 Hospital, Ankang Central Hospital
Study start: Jan 2017 (actual)
Primary completion: Dec 2020 (actual)
Study completion: Dec 2020 (actual)
First posted: 5 Dec 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Full enteral feeding	Active comparator	Other: Initial enteral feedingThe 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.
Modified full enteral feeding	Experimental	Other: Initial enteral feeding, Drug: metoclopramide or mosaprideConsistent with full enteral feeding plan, preventively add metoclopramide or mosapride everyday to improve gastrointestinal (GI) motility.
Permissive underfeeding	Experimental	Other: Initial enteral feedingThe 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Initial enteral feeding	Other	Full enteral feeding, Modified full enteral feeding, Permissive underfeeding
metoclopramide or mosapridegastrointestinal (GI) motility improving	Drug	Modified full enteral feeding

Primary outcome

Rate of patients with death or major disability (modified Rankin scale score ≥3)
Time frame: 3 months after enrollment
modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.

10 secondary outcomes

Mortality (rate of patients with death)
Time frame: 3 months after enrollment
The scores of National Institute of Health stroke scale
Time frame: 7 days after enrollment
Glasgow Coma Scale
Time frame: 7 days after enrollment
modified Rankin scale
Time frame: 7 days after enrollment
Barthel index
Time frame: 7 days after enrollment
modified Rankin scale
Time frame: 3 months after enrollment
Barthel index
Time frame: 3 months after enrollment
The incidence of treatment intolerance
Time frame: 7 days after enrollment
The incidence of serious adverse events
Time frame: 3 months after enrollment
The incidence of adverse events That are related to treatment
Time frame: 3 months after enrollment

Results and safety

The study was stopped early (reason given: Significantly higher mortality). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
Background: PubMed 24289189Wirth 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.
Background: PubMed 26773077McClave 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.
Results publication: PubMed 12750536FOOD 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.
Results publication: PubMed 20130154Ukleja 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.
Results publication: PubMed 15733717Dennis 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.
Results publication: PubMed 20971534Heyland 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.
Results publication: PubMed 22673593Jie 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.
Results publication: PubMed 22307571National 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.
Results publication: PubMed 26398094Permissive 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.
Derived from this study: PubMed 39145517Sakai 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.
Derived from this study: PubMed 35219379Zhao 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.
Derived from this study: PubMed 30755171Yuan 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wen Jiang, PhD study director

Department of Neurology, Xijing Hospital, Fourth Military Medical University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Initial enteral feeding and metoclopramide or mosapride in people with Severe Stroke and Acute Stroke, run by Xijing Hospital at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Significantly higher mortality). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of patients with death or major disability (modified Rankin scale score ≥3) (time frame: 3 months after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02982668, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.