Optimizing Early Nutrition Support in Severe Stroke-2

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05998902

Enrollment

546

Registered

2023-08-21

Start date

2023-12-20

Completion date

2026-05-27

Last updated

2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Stroke, Dysphagia, Severe Stroke

Keywords

Severe Stroke, Acute Stroke, Dysphagia, supplemental parenteral nutrition, trophic feeding, pneumonia

Brief 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. 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.

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.

Interventions

PROCEDURETrophic enteral feeding combined with supplemental parenteral nutrition

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.

PROCEDUREFull enteral feeding

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Incidence of post stroke pneumonia	up to 7 days

Secondary

Measure	Time frame	Description
The time from randomisation to the onset of the post stroke pneumonia	up to 7 days	—
Daily calorie delivery	up to 7 days	—
Daily protein delivery	up to 7 days	—
Insulin utilization	up to 7 days	Insulin utilization during the first 7 days post-randomization
The incidence of gastrointestinal complications	up to 7 days	Vomiting, diarrhea, gastric retention, gastrointestinal bleeding
The use of prokinetic agents	up to 7 days	The usage rate of prokinetic agents
The occurrence of infections	1 day of ICU discharge	The rate and onset time of infections from randomisation to ICU discharge
The length of ICU stay	1 day of ICU discharge	—
Mortality	1 day of ICU discharge	from randomisation to all cause death during ICU stay.
The All-cause mortality rate	28 days after enrollment	from randomisation to all cause death at 28 days
Cardiac failure	1 day of ICU discharge	The incidence of cardiac failure from randomisation to ICU discharge
Tracheotomy	1 day of ICU discharge	The incidence of tracheotomy from randomisation to ICU discharge
Mechanical ventilation	1 day of ICU discharge	The incidence of mechanical ventilation from randomisation to ICU discharge
Continuous renal replacement therapy	1 day of ICU discharge	The incidence of continuous renal replacement therapy from randomisation to ICU discharge
The use of vasoactive agents	1 day of ICU discharge	The usage rate of vasoactive agents from randomisation to ICU discharge
Deep venous thrombosis	1 day of ICU discharge	The incidence of deep venous thrombosis from randomisation to ICU discharge
The score of National Institute of Health stroke scale at ICU discharge	1 day of 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.
Glasgow Coma Scale at ICU discharge	1 day of ICU discharge	Glasgow Coma Scale,with scores ranging from 3 (no response) to 15 (normal response), was used to grade the conscious state.
modified Rankin scale at ICU discharge	1 day of ICU discharge	modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.
modified Rankin scale	90 days after enrollment	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)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026