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Optimizing nutrition support for patients with severe stroke

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

Phase 3 Interventional Xijing Hospital · NCT05998902

This study is testing which type of nutrition support helps patients with severe strokes reduce the risk of pneumonia and improve their recovery during the first week after their stroke.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment546 (estimated)
Ages18 Years and up
SexAll
SponsorXijing Hospital Academic / other
Locations30 sites (Chongqing, Chongqing Municipality and 29 other locations)
Trial IDNCT05998902 on ClinicalTrials.gov

What this trial studies

This study aims to determine the most effective nutrition support strategy for patients with acute severe stroke to reduce the risk of post-stroke pneumonia (PSP) and improve overall prognosis. It will enroll 546 patients who will be randomly assigned to receive either full enteral feeding or a combination of trophic enteral feeding and supplemental parenteral nutrition for 7 days. The study focuses on addressing the complications associated with aspiration and poor nutritional status in severe stroke patients, particularly during the critical first week after the stroke event.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of acute severe stroke and a need for nutritional support.

Not a fit: Patients with contraindications for enteral nutrition or those with a life expectancy of less than 7 days may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of pneumonia and improve recovery outcomes for patients with severe stroke.

How similar studies have performed: Previous studies have indicated that alternative nutritional strategies can reduce complications in stroke patients, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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

Exclusion Criteria:

1. Receiving parenteral nutrition support
2. Contraindications of enteral nutrition
3. Complicated with the disease which only have life expectancy \< 7 days
4. Admission with infection signs
5. Dementia or severe disability (mRS\>4) before stroke
6. Antibiotics were used within the previous 7 days
7. Subarachnoid hemorrhage, cerebral arteriovenous malformation
8. 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 \[glomerular filtration rate ≤30mL/min or serum creatinine ≥4mg/dL\]
9. Currently participating in other clinical trial
10. Pregnant woman
11. Patient who is considered highly likely not to adhere to the study treatment or follow-up protocol.

Where this trial is running

Chongqing, Chongqing Municipality and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Severe StrokeAcute StrokeDysphagiasupplemental parenteral nutritiontrophic feedingpneumonia
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.