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Severe StrokePhase 3NCT05998902

Optimizing Early Nutrition Support in Severe Stroke-2

A Phase 3 study testing Trophic enteral feeding combined with supplemental parenteral nutrition and Full enteral feeding in people with Severe Stroke and Acute Stroke, run by Wen Jiang-3 at 30 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Post stroke pneumonia (PSP) is one of the common early complications of stroke. Post-stroke infections, in general, are associated with less favorable neurologic outcomes. Aspiration is one of the most feared complications of enteral nutrition and can lead to the occurrence of pneumonia. 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?
Trophic enteral feeding combined with supplemental parenteral nutrition and Full enteral feeding
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
546 participants
Where
30 sitesChina
Study dates
20 Dec 2023to 27 May 2026
Phase
Phase 3
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

  • Age≥18 years
  • Definite diagnosis of acute stroke (GCS ≤12 or NIHSS≥11)
  • The randomized nutritional treatment could be initiated up to 72 hours after symptom onset.
  • Any cases of profiles #3 through 5 in Water Swallowing Test or with disorder of consciousness.
  • Plan to receive nutritional support treatment for at least 7 days.
  • Informed consent.

Who cannot join

  • Receiving parenteral nutrition support
  • Contraindications of enteral nutrition
  • Complicated with the disease which only have life expectancy < 7 days
  • Admission with infection signs
  • Dementia or severe disability (mRS>4) before stroke
  • Antibiotics were used within the previous 7 days
Show all 11Show fewer
  • Subarachnoid hemorrhage, cerebral arteriovenous malformation
  • Presence of coexisting medical conditions that could interfere with outcome assessment and/or follow-up (a. advanced cancer; b. severe pulmonary dysfunction [forced expiratory volume in 1 second < 50% or/and moderate to severe acute lung injury (PaO2/FiO2)<200mmHg]; c. cardiac insufficiency (NYHA class > I; cardiac structural and/or functional abnormalities such as EF< 50%, abnormal cardiac chamber enlargement, moderate/severe ventricular hypertrophy, or moderate/severe valvular stenosis); d. Severe liver failure [Child-Pugh score≥7]; e. Severe renal failure [glomerular filtration rate ≤30mL/min or serum creatinine ≥4mg/dL]
  • Currently participating in other clinical trial
  • Pregnant woman
  • Patient who is considered highly likely not to adhere to the study treatment or follow-up protocol.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

China30 sites

  • The First Hospital of Changsha City

    Changsha, Hunan

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404100

  • Daping Hospital, The Third Military Medical University

    Chongqing, Chongqing Municipality

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong

  • The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550000

  • Qilu Hospital of Shangdong University

    Jinan, Shandong

  • The PLA 960 Hospital

    Jinan, Shandong

  • The Second Hospital of Shandong University

    Jinan, Shandong

  • Gansu Provincal Central Hospital

    Lanzhou, Gansu

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252000

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, 830000

  • The Second Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

  • Tongji Hospital

    Wuhan, Hubei

  • Shaanxi Second Provincal People's Hospital

    Xi'an, Shaanxi, 710000

  • Tangdu Hospital

    Xi'an, Shaanxi, 710000

  • The first affiliated hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710000

  • Xi'an Central Hospital

    Xi'an, Shaanxi, 710000

  • Department of Neurology, Xijing Hospital

    Xi'an, Shaanxi

  • Shannxi Provincal People's Hospital

    Xi'an, Shaanxi

  • The First Affiliated Hospital of Xi'an Medical University

    Xi'an, Shaanxi

  • Xi'an Gaoxin Hospital

    Xi'an, Shaanxi

  • Xi'an No.3 Hospital

    Xi'an, Shaanxi

  • Xianyang Hospital, Yan'an University

    Xianyang, Shaanxi, 712000

  • The First People's Hospital of Xianyang

    Xianyang, Shaanxi

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750000

  • Yulin No.1 Hospital

    Yulin, Shaanxi

  • Yulin No.2 Hospital

    Yulin, Shaanxi

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Trophic Enteral Feeding Combined With Supplemental Parenteral Nutrition Treatment in Patients With Severe Stroke (OPENS-2): a Multicentre, Prospective, Randomised, Open-label, Blinded-endpoint Trial

Post stroke pneumonia (PSP) is one of the common early complications of stroke. Post-stroke infections, in general, are associated with less favorable neurologic outcomes. Aspiration is one of the most feared complications of enteral nutrition and can lead to the occurrence of pneumonia. Severe stroke patients are at high risk for aspiration due to some factors such as the reduced level of consciousness, inability to protect the airway and so on. The purpose of this study is to explore the ideal nutrition support strategy for patient with acute severe stroke to help reduce the incidence of PSP and improve the prognosis.

Read the detailed description

As one of the most common complication of stroke, some studies showed that post-stroke pneumonia (PSP) in stroke patients requiring intensive care is associated with an increase of ICU length of stay and hospital mortality and poorer functional outcomes in survivors. The peak period of PSP is within the first week after stroke. Aspiration and poor nutritional status are important factors leading to pneumonia in stroke patients. Compared with full enteral nutrition (EN), initial trophic enteral feeding was associated with less gastrointestinal intolerance and could reduce the rate of regurgitation. However, trophic enteral feeding could not meet the daily caloric needs and hypocaloric enteral nutrition might be associated with increased mortality. This study is designed to explore whether initial trophic enteral nutrition combined with supplemental parenteral nutrition (SPN) can help reduce the incidence of PSP and improve the prognosis in severe patients with stroke.

This study will enroll 546 severe stroke patients who meet the inclusion criteria. Upon admission to the ICU, patients will be randomly assigned at a 1:1 ratio into groups of full enteral feeding (controlled) and trophic enteral feeding combined with supplemental parenteral feeding (experimented) for 7 days.

Being tested
Trophic enteral feeding combined with supplemental parenteral nutrition, Full enteral feeding
Keywords
Severe Stroke, Acute Stroke, Dysphagia, supplemental parenteral nutrition, trophic feeding, pneumonia
Medical subject headings
Stroke, Deglutition Disorders, Pneumonia

What participants receive

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

  • Trophic enteral feeding combined with supplemental parenteral nutritionProcedure or surgery

    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. Patients will receive the trophic enteral feeding with a caloric target of 500kcal/d (20-35ml/h), and the remaining calories are supplemented by parenteral nutrition. Protein requirements are calculated at 1.2 to 1.5 g per kilogram of body weight per day.

  • Full enteral feedingProcedure or surgery

    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. Enteral nutrition is given through nasogastric tube or nasointestinal tube.

Study groups in NCT05998902
Study groupRoleWhat they receive
Full enteral feedingActive comparatorPatients will receive full enteral feeding through nasogastric tube or nasointestinal tube.
Receives: Procedure: Full enteral feeding
Trophic enteral feeding combined with supplemental parenteral nutritionExperimentalPatients will receive trophic enteral feeding combined with supplemental parenteral feeding.
Receives: Procedure: Trophic enteral feeding combined with supplemental parenteral nutrition

What is being measured

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

  1. Incidence of post stroke pneumonia

    Measured: up to 7 days

Secondary outcomes (20)

  1. The time from randomisation to the onset of the post stroke pneumonia

    Measured: up to 7 days

  2. Daily calorie delivery

    Measured: up to 7 days

  3. Daily protein delivery

    Measured: up to 7 days

  4. Insulin utilization

    Insulin utilization during the first 7 days post-randomization

    Measured: up to 7 days

  5. The incidence of gastrointestinal complications

    Vomiting, diarrhea, gastric retention, gastrointestinal bleeding

    Measured: up to 7 days

  6. The use of prokinetic agents

    The usage rate of prokinetic agents

    Measured: up to 7 days

  7. The occurrence of infections

    The rate and onset time of infections from randomisation to ICU discharge

    Measured: 1 day of ICU discharge

  8. The length of ICU stay

    Measured: 1 day of ICU discharge

  9. Mortality

    from randomisation to all cause death during ICU stay.

    Measured: 1 day of ICU discharge

  10. The All-cause mortality rate

    from randomisation to all cause death at 28 days

    Measured: 28 days after enrollment

  11. Cardiac failure

    The incidence of cardiac failure from randomisation to ICU discharge

    Measured: 1 day of ICU discharge

  12. Tracheotomy

    The incidence of tracheotomy from randomisation to ICU discharge

    Measured: 1 day of ICU discharge

  13. Mechanical ventilation

    The incidence of mechanical ventilation from randomisation to ICU discharge

    Measured: 1 day of ICU discharge

  14. Continuous renal replacement therapy

    The incidence of continuous renal replacement therapy from randomisation to ICU discharge

    Measured: 1 day of ICU discharge

  15. The use of vasoactive agents

    The usage rate of vasoactive agents from randomisation to ICU discharge

    Measured: 1 day of ICU discharge

  16. Deep venous thrombosis

    The incidence of deep venous thrombosis from randomisation to ICU discharge

    Measured: 1 day of ICU discharge

  17. The score of National Institute of Health stroke scale at ICU discharge

    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: 1 day of ICU discharge

  18. Glasgow Coma Scale at ICU discharge

    Glasgow Coma Scale,with scores ranging from 3 (no response) to 15 (normal response), was used to grade the conscious state.

    Measured: 1 day of ICU discharge

  19. modified Rankin scale at ICU discharge

    modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.

    Measured: 1 day of ICU discharge

  20. 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, including ordinal mRS, excellent outcome (mRS 0-1), and functional independence (mRS 0-2)

    Measured: 90 days after enrollment

Timeline

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

  1. First posted21 Aug 2023
  2. Study start20 Dec 2023
  3. Primary completion6 Mar 2026
  4. Study completion27 May 2026

Resources

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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
546 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05998902
Sponsor's protocol ID
XJLL-KY-20222214
Status last verified
Jun 2026
First submitted
26 Jul 2023
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Meisel A, Smith CJ. Prevention of stroke-associated pneumonia: where next? Lancet. 2015 Nov 7;386(10006):1802-4. doi: 10.1016/S0140-6736(15)00127-0. Epub 2015 Sep 3. No abstract available.

    PubMed 26343837

  • Wilson RD. Mortality and cost of pneumonia after stroke for different risk groups. J Stroke Cerebrovasc Dis. 2012 Jan;21(1):61-7. doi: 10.1016/j.jstrokecerebrovasdis.2010.05.002. Epub 2010 Jun 17.

    PubMed 22225864

  • Kishore AK, Vail A, Chamorro A, Garau J, Hopkins SJ, Di Napoli M, Kalra L, Langhorne P, Montaner J, Roffe C, Rudd AG, Tyrrell PJ, van de Beek D, Woodhead M, Meisel A, Smith CJ. How is pneumonia diagnosed in clinical stroke research? A systematic review and meta-analysis. Stroke. 2015 May;46(5):1202-9. doi: 10.1161/STROKEAHA.114.007843. Epub 2015 Apr 9.

    PubMed 25858238

  • Suda S, Aoki J, Shimoyama T, Suzuki K, Sakamoto Y, Katano T, Okubo S, Nito C, Nishiyama Y, Mishina M, Kimura K. Stroke-associated infection independently predicts 3-month poor functional outcome and mortality. J Neurol. 2018 Feb;265(2):370-375. doi: 10.1007/s00415-017-8714-6. Epub 2017 Dec 16.

    PubMed 29249057

  • Cohen DL, Roffe C, Beavan J, Blackett B, Fairfield CA, Hamdy S, Havard D, McFarlane M, McLauglin C, Randall M, Robson K, Scutt P, Smith C, Smithard D, Sprigg N, Warusevitane A, Watkins C, Woodhouse L, Bath PM. Post-stroke dysphagia: A review and design considerations for future trials. Int J Stroke. 2016 Jun;11(4):399-411. doi: 10.1177/1747493016639057. Epub 2016 Mar 22.

    PubMed 27006423

  • Westendorp WF, Nederkoorn PJ, Vermeij JD, Dijkgraaf MG, van de Beek D. Post-stroke infection: a systematic review and meta-analysis. BMC Neurol. 2011 Sep 20;11:110. doi: 10.1186/1471-2377-11-110.

    PubMed 21933425

  • Finlayson O, Kapral M, Hall R, Asllani E, Selchen D, Saposnik G; Canadian Stroke Network; Stroke Outcome Research Canada (SORCan) Working Group. Risk factors, inpatient care, and outcomes of pneumonia after ischemic stroke. Neurology. 2011 Oct 4;77(14):1338-45. doi: 10.1212/WNL.0b013e31823152b1. Epub 2011 Sep 21.

    PubMed 21940613

  • de Montmollin E, Ruckly S, Schwebel C, Philippart F, Adrie C, Mariotte E, Marcotte G, Cohen Y, Sztrymf B, da Silva D, Bruneel F, Gainnier M, Garrouste-Orgeas M, Sonneville R, Timsit JF; OUTCOMEREA Study Group. Pneumonia in acute ischemic stroke patients requiring invasive ventilation: Impact on short and long-term outcomes. J Infect. 2019 Sep;79(3):220-227. doi: 10.1016/j.jinf.2019.06.012. Epub 2019 Jun 22.

    PubMed 31238051

  • Suntrup-Krueger S, Kemmling A, Warnecke T, Hamacher C, Oelenberg S, Niederstadt T, Heindel W, Wiendl H, Dziewas R. The impact of lesion location on dysphagia incidence, pattern and complications in acute stroke. Part 2: Oropharyngeal residue, swallow and cough response, and pneumonia. Eur J Neurol. 2017 Jun;24(6):867-874. doi: 10.1111/ene.13307. Epub 2017 Apr 27.

    PubMed 28449405

  • Al-Khaled M. The multifactorial etiology of stroke-associated pneumonia. J Neurol Sci. 2019 May 15;400:30-31. doi: 10.1016/j.jns.2019.02.042. Epub 2019 Mar 12. No abstract available.

    PubMed 30884370

  • McClave SA, DeMeo MT, DeLegge MH, DiSario JA, Heyland DK, Maloney JP, Metheny NA, Moore FA, Scolapio JS, Spain DA, Zaloga GP. North American Summit on Aspiration in the Critically Ill Patient: consensus statement. JPEN J Parenter Enteral Nutr. 2002 Nov-Dec;26(6 Suppl):S80-5. doi: 10.1177/014860710202600613.

    PubMed 12405628

  • Jabbar A, Chang WK, Dryden GW, McClave SA. Gut immunology and the differential response to feeding and starvation. Nutr Clin Pract. 2003 Dec;18(6):461-82. doi: 10.1177/0115426503018006461.

    PubMed 16215082

  • Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.

    PubMed 30348463

  • Uozumi M, Sanui M, Komuro T, Iizuka Y, Kamio T, Koyama H, Mouri H, Masuyama T, Ono K, Lefor AK. Interruption of enteral nutrition in the intensive care unit: a single-center survey. J Intensive Care. 2017 Aug 4;5:52. doi: 10.1186/s40560-017-0245-9. eCollection 2017.

    PubMed 28794882

  • Harvey SE, Parrott F, Harrison DA, Bear DE, Segaran E, Beale R, Bellingan G, Leonard R, Mythen MG, Rowan KM; CALORIES Trial Investigators. Trial of the route of early nutritional support in critically ill adults. N Engl J Med. 2014 Oct 30;371(18):1673-84. doi: 10.1056/NEJMoa1409860. Epub 2014 Oct 1.

    PubMed 25271389

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trophic enteral feeding combined with supplemental parenteral nutrition and Full enteral feeding in people with Severe Stroke and Acute Stroke, run by Wen Jiang-3 at 30 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of post stroke pneumonia (time frame: up to 7 days). 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 NCT05998902, which also lists 22 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 24 Jun 2026.

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