Back to resultsOptimizing Early Nutrition Support in Severe Stroke-2
Primary Purpose
Severe Stroke, Acute Stroke, Dysphagia
Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Trophic enteral feeding combined with supplemental parenteral nutrition
Full enteral feeding
Sponsored by
About this trial
This is an interventional supportive care trial for Severe Stroke focused on measuring Severe Stroke, Acute Stroke, Dysphagia, supplemental parenteral nutrition, trophic feeding, pneumonia
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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.
Sites / Locations
- Daping Hospital, The Third Military Medical University
- Gansu Provincal Central Hospital
- Nanfang Hospital, Southern Medical University
- The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
- First Affiliated Hospital of Zhengzhou University
- Tongji Hospital
- The First Hospital of Changsha City
- Tangdu Hospital
- Xi'an Central Hospital
- Department of Neurology, Xijing Hospital
- Shannxi Provincal People's Hospital
- The First Affiliated Hospital of Xi'an Medical University
- Xi'an Gaoxin Hospital
- Xi'an No.3 Hospital
- The First People's Hospital of Xianyang
- Yulin No.1 Hospital
- Yulin No.2 Hospital
- Qilu Hospital of Shangdong University
- The PLA 960 Hospital
- The Second Hospital of Shandong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Full enteral feeding
Trophic enteral feeding combined with supplemental parenteral nutrition
Arm Description
Patients will receive full enteral feeding through nasogastric tube or nasointestinal tube.
Patients will receive trophic enteral feeding combined with supplemental parenteral feeding.
Outcomes
Primary Outcome Measures
Incidence of post stroke pneumonia
Secondary Outcome Measures
The time from randomisation to the onset of the post stroke pneumonia
Daily calorie delivery
Daily protein delivery
Insulin dosage
The incidence of gastrointestinal complications
Vomiting, diarrhea, gastric retention, gastrointestinal bleeding
The use of prokinetic agents
The usage rate of prokinetic agents
The occurrence of infections
The rate and onset time of infections from randomisation to ICU discharge
The length of ICU stay
Mortality
from randomisation to all cause death during ICU stay.
The All-cause mortality rate
from randomisation to all cause death at 28 days
Cardiac failure
The incidence of cardiac failure from randomisation to ICU discharge
Tracheotomy
The incidence of tracheotomy from randomisation to ICU discharge
Mechanical ventilation
The incidence of mechanical ventilation from randomisation to ICU discharge
Continuous renal replacement therapy
The incidence of continuous renal replacement therapy from randomisation to ICU discharge
The use of vasoactive agents
The usage rate of vasoactive agents from randomisation to ICU discharge
Deep venous thrombosis
The incidence of deep venous thrombosis from randomisation to ICU discharge
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.
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.
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.
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.
Full Information
NCT ID
NCT05998902
First Posted
July 26, 2023
Last Updated
August 11, 2023
Sponsor
Wen Jiang-3
Collaborators
Tang-Du Hospital, Xi'an Central Hospital, Xi'an Gaoxin Hospital, First Affiliated Hospital of Xi'an Medical University, Xi'an No.3 Hospital, First People's Hospital of Xianyang, Nanfang Hospital, Southern Medical University, Tongji Hospital, Qilu Hospital of Shandong University, The Second Hospital of Shandong University, PLA 960 Hospital, Daping Hospital, The Third Military Medical University (Army Medical University), The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, First Hospital Affiliated to Zhengzhou University, Gansu Provincial Central Hospital, The First Hospital of Changsha City, Shaanxi Provincial People's Hospital, Yulin No.2 Hospital, Yulin No.1 Hospital, Xijing Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05998902
Brief Title
Optimizing Early Nutrition Support in Severe Stroke-2
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 14, 2023 (Anticipated)
Primary Completion Date
July 31, 2026 (Anticipated)
Study Completion Date
October 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wen Jiang-3
Collaborators
Tang-Du Hospital, Xi'an Central Hospital, Xi'an Gaoxin Hospital, First Affiliated Hospital of Xi'an Medical University, Xi'an No.3 Hospital, First People's Hospital of Xianyang, Nanfang Hospital, Southern Medical University, Tongji Hospital, Qilu Hospital of Shandong University, The Second Hospital of Shandong University, PLA 960 Hospital, Daping Hospital, The Third Military Medical University (Army Medical University), The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, First Hospital Affiliated to Zhengzhou University, Gansu Provincial Central Hospital, The First Hospital of Changsha City, Shaanxi Provincial People's Hospital, Yulin No.2 Hospital, Yulin No.1 Hospital, Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Stroke, Acute Stroke, Dysphagia
Keywords
Severe Stroke, Acute Stroke, Dysphagia, supplemental parenteral nutrition, trophic feeding, pneumonia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
546 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Full enteral feeding
Arm Type
Active Comparator
Arm Description
Patients will receive full enteral feeding through nasogastric tube or nasointestinal tube.
Arm Title
Trophic enteral feeding combined with supplemental parenteral nutrition
Arm Type
Experimental
Arm Description
Patients will receive trophic enteral feeding combined with supplemental parenteral feeding.
Intervention Type
Procedure
Intervention Name(s)
Trophic enteral feeding combined with supplemental parenteral nutrition
Intervention 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. 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.
Intervention Type
Procedure
Intervention Name(s)
Full enteral feeding
Intervention 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. Enteral nutrition is given through nasogastric tube or nasointestinal tube.
Primary Outcome Measure Information:
Title
Incidence of post stroke pneumonia
Time Frame
up to 7 days
Secondary Outcome Measure Information:
Title
The time from randomisation to the onset of the post stroke pneumonia
Time Frame
up to 7 days
Title
Daily calorie delivery
Time Frame
up to 7 days
Title
Daily protein delivery
Time Frame
up to 7 days
Title
Insulin dosage
Time Frame
up to 7 days
Title
The incidence of gastrointestinal complications
Description
Vomiting, diarrhea, gastric retention, gastrointestinal bleeding
Time Frame
up to 7 days
Title
The use of prokinetic agents
Description
The usage rate of prokinetic agents
Time Frame
up to 7 days
Title
The occurrence of infections
Description
The rate and onset time of infections from randomisation to ICU discharge
Time Frame
1 day of ICU discharge
Title
The length of ICU stay
Time Frame
1 day of ICU discharge
Title
Mortality
Description
from randomisation to all cause death during ICU stay.
Time Frame
1 day of ICU discharge
Title
The All-cause mortality rate
Description
from randomisation to all cause death at 28 days
Time Frame
28 days after enrollment
Title
Cardiac failure
Description
The incidence of cardiac failure from randomisation to ICU discharge
Time Frame
1 day of ICU discharge
Title
Tracheotomy
Description
The incidence of tracheotomy from randomisation to ICU discharge
Time Frame
1 day of ICU discharge
Title
Mechanical ventilation
Description
The incidence of mechanical ventilation from randomisation to ICU discharge
Time Frame
1 day of ICU discharge
Title
Continuous renal replacement therapy
Description
The incidence of continuous renal replacement therapy from randomisation to ICU discharge
Time Frame
1 day of ICU discharge
Title
The use of vasoactive agents
Description
The usage rate of vasoactive agents from randomisation to ICU discharge
Time Frame
1 day of ICU discharge
Title
Deep venous thrombosis
Description
The incidence of deep venous thrombosis from randomisation to ICU discharge
Time Frame
1 day of ICU discharge
Title
The score of National Institute of Health stroke scale at ICU discharge
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.
Time Frame
1 day of ICU discharge
Title
Glasgow Coma Scale at ICU discharge
Description
Glasgow Coma Scale,with scores ranging from 3 (no response) to 15 (normal response), was used to grade the conscious state.
Time Frame
1 day of ICU discharge
Title
modified Rankin scale at ICU discharge
Description
modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.
Time Frame
1 day of ICU discharge
Title
modified Rankin scale
Description
modified Rankin scale score, with score ranging from 0 (normal) to 6 (death), was used to evaluate the functional outcomes after stroke.
Time Frame
90 days after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen Jiang, Ph.D
Phone
86-029-84771319
Email
jiangwen@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xuan Wang, MD
Phone
86-029-84773664
Email
786369892@qq.com
Facility Information:
Facility Name
Daping Hospital, The Third Military Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meng Zhang
Facility Name
Gansu Provincal Central Hospital
City
Lanzhou
State/Province
Gansu
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong Yin
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suyue Pan
Facility Name
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lixin Wang
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenjing Deng
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Furong Wang
Facility Name
The First Hospital of Changsha City
City
Changsha
State/Province
Hunan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Tan
Facility Name
Tangdu Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Guo, PhD
Facility Name
Xi'an Central Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengli Di, PhD
Facility Name
Department of Neurology, Xijing Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Jiang, Ph.D
Phone
86-029-84771319
Email
jiangwen@fmmu.edu.cn
Facility Name
Shannxi Provincal People's Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Lv
Facility Name
The First Affiliated Hospital of Xi'an Medical University
City
Xi'an
State/Province
Shaanxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bei Zhang
Facility Name
Xi'an Gaoxin Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Jia
Facility Name
Xi'an No.3 Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingze Chang
Facility Name
The First People's Hospital of Xianyang
City
Xianyang
State/Province
Shaanxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liping Yu
Facility Name
Yulin No.1 Hospital
City
Yulin
State/Province
Shaanxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongfeng Huang
Facility Name
Yulin No.2 Hospital
City
Yulin
State/Province
Shaanxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xue Li
Facility Name
Qilu Hospital of Shangdong University
City
Jinan
State/Province
Shandong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinzhou Wang
Facility Name
The PLA 960 Hospital
City
Jinan
State/Province
Shandong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huaiqiang Hu
Facility Name
The Second Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Shang
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26343837
Citation
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.
Results Reference
background
PubMed Identifier
22225864
Citation
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.
Results Reference
background
PubMed Identifier
25858238
Citation
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.
Results Reference
background
PubMed Identifier
29249057
Citation
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.
Results Reference
background
PubMed Identifier
27006423
Citation
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.
Results Reference
background
PubMed Identifier
21933425
Citation
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.
Results Reference
background
PubMed Identifier
21940613
Citation
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.
Results Reference
background
PubMed Identifier
31238051
Citation
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.
Results Reference
background
PubMed Identifier
28449405
Citation
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.
Results Reference
background
PubMed Identifier
30884370
Citation
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.
Results Reference
background
PubMed Identifier
12405628
Citation
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.
Results Reference
background
PubMed Identifier
16215082
Citation
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.
Results Reference
background
PubMed Identifier
30348463
Citation
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.
Results Reference
background
PubMed Identifier
28794882
Citation
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.
Results Reference
background
PubMed Identifier
25271389
Citation
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.
Results Reference
background
PubMed Identifier
21531737
Citation
Altintas ND, Aydin K, Turkoglu MA, Abbasoglu O, Topeli A. Effect of enteral versus parenteral nutrition on outcome of medical patients requiring mechanical ventilation. Nutr Clin Pract. 2011 Jun;26(3):322-9. doi: 10.1177/0884533611405790. Epub 2011 Apr 29.
Results Reference
background
PubMed Identifier
29128300
Citation
Reignier J, Boisrame-Helms J, Brisard L, Lascarrou JB, Ait Hssain A, Anguel N, Argaud L, Asehnoune K, Asfar P, Bellec F, Botoc V, Bretagnol A, Bui HN, Canet E, Da Silva D, Darmon M, Das V, Devaquet J, Djibre M, Ganster F, Garrouste-Orgeas M, Gaudry S, Gontier O, Guerin C, Guidet B, Guitton C, Herbrecht JE, Lacherade JC, Letocart P, Martino F, Maxime V, Mercier E, Mira JP, Nseir S, Piton G, Quenot JP, Richecoeur J, Rigaud JP, Robert R, Rolin N, Schwebel C, Sirodot M, Tinturier F, Thevenin D, Giraudeau B, Le Gouge A; NUTRIREA-2 Trial Investigators; Clinical Research in Intensive Care and Sepsis (CRICS) group. Enteral versus parenteral early nutrition in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2). Lancet. 2018 Jan 13;391(10116):133-143. doi: 10.1016/S0140-6736(17)32146-3. Epub 2017 Nov 8.
Results Reference
background
PubMed Identifier
34784064
Citation
Compher C, Bingham AL, McCall M, Patel J, Rice TW, Braunschweig C, McKeever L. Guidelines for the provision of nutrition support therapy in the adult critically ill patient: The American Society for Parenteral and Enteral Nutrition. JPEN J Parenter Enteral Nutr. 2022 Jan;46(1):12-41. doi: 10.1002/jpen.2267. Epub 2022 Jan 3. Erratum In: JPEN J Parenter Enteral Nutr. 2022 Aug;46(6):1458-1459.
Results Reference
background
PubMed Identifier
23218813
Citation
Heidegger CP, Berger MM, Graf S, Zingg W, Darmon P, Costanza MC, Thibault R, Pichard C. Optimisation of energy provision with supplemental parenteral nutrition in critically ill patients: a randomised controlled clinical trial. Lancet. 2013 Feb 2;381(9864):385-93. doi: 10.1016/S0140-6736(12)61351-8. Epub 2012 Dec 3.
Results Reference
background
PubMed Identifier
30313021
Citation
Shi J, Wei L, Huang R, Liao L. Effect of combined parenteral and enteral nutrition versus enteral nutrition alone for critically ill patients: A systematic review and meta-analysis. Medicine (Baltimore). 2018 Oct;97(41):e11874. doi: 10.1097/MD.0000000000011874.
Results Reference
background
PubMed Identifier
22307571
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.
Results Reference
background
PubMed Identifier
35219379
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.
Results Reference
background
Learn more about this trial
Optimizing Early Nutrition Support in Severe Stroke-2
We'll reach out to this number within 24 hrs