Nutritional StatusNCT03606603
Nutrition Insights Day Asia
An observational study of Nutritional Status and Malnutrition, run by Fresenius Kabi at 89 sites in 7 countries.
Trial summary
This is an observational, cross-sectional study to be conducted on the Nutrition Insights Day (NID), with retrospective review of patient medical charts. No prospective follow-up period is considered. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutritional Status, Malnutrition, Caloric Deficit
- How many people
- 590 participants
- Where
- 89 sitesin 7 countries
- Study dates
- 15 Mar 2019to 28 Jun 2019
- Phase
- Observational
- 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
Study population: Adult patients after elective major abdominal gastrointestinal surgery with pre-existing malnutrition or who are at significant risk for malnutrition or nutrition-related complications, with indications for nutritional support
Who may be able to join
- Adult patients after elective major abdominal gastrointestinal surgery [i.e. elective major GI resections, partial or total, especially for cancer, including: esophagectomy, gastrectomy, enterectomy (small bowel resection), colectomy, hepatectomy, pancreatectomy, resections for gall bladder or bile duct cancer (cholangiocarcinoma)] with pre-existing malnutrition or who are at significant risk for malnutrition or nutrition-related complications*, with indications for nutritional support
- Hospitalization on SICU or major surgical ward on the NID
- Use of EN (nutritional intake provided via tube feeding) and/or PN for at least one day before the NID
- If patient received oral nutrition (ON) or oral nutrition supplements (ONS) during the observational phase from day -5 to day -2, complete and reliable data of daily caloric and protein intake is available
- Latest surgical intervention ≤ 10 days before NID
Who cannot join
- Patients with burn injuries
- Patients requiring postsurgical mechanical ventilation and sedation on the NID
- Patients receiving ON and/or ONS at any quantity on the day before the NID
- Patients requiring emergency procedures
Trial locations and contacts
89 sites in 7 countries.
89 sites in 7 countries
India27 sites
Manipal Hospital
Bangalore
Bombay Hospital
Bombay
Apollo Hospitals
Chennai
SIMS (SRM Institutes for Medical Science)
Chennai
G. Kuppuswamy Naidu Memorial Hospital
Coimbatore
Max Super Speciality Hospital
Dehli
Sir Ganga Ram Hospital
Dehli
AMRI Hospital
Dhakuria
Fortis Memorial Research Institute
Gūrgaon
Medanta Medicity Hospital
Gūrgaon
Care Hospital
Hyderabad
Rukmani Birla Hospital, A Unit of CMRI
Jaipur
Rukmani Birla Hospital
Jaipur
Apollo Gleneagles Hospitals Ltd.
Kolkata
Dayanand Medical College and Hospital
Ludhiana
Fortis Hospital
Mohali
Max Superspecialty Hospital
Mohali
B. Y. L. Nair Charitable Hospital & Topiwala National Medical College
Mumbai
S.L Raheja - A Fortis Associate Hospital
Mumbai
BLK Super Specialty Hospital
New Delhi
Jawaharlal Institute Of Post Graduate Medical Education Medical Education and Research (JIPMER)
Puducherry
Deenanath Mangeshkar Hospital
Pune
Ruby Hall Clinic
Pune
Krishna Institute of Medical Sciences
Secunderabad
Surat Institute of Digestive Sciences
Sūrat
Geetanjali Medical College
Udaipur
Christian Medical College & Hospital
Vellore
Philippines18 sites
Capitol University Medical Center
Cagayan de Oro
Cebu Doctors University Hospital
Cebu City
Perpetual Succour Hospital
Cebu City
De La Salle University Medical Center
Dasmariñas
Southern Philippines Medical Center
Davao City
Makati Medical Center
Makati City
Asian Hospital and Medical Center
Manila
Dr. Jose R.Reyes Memorial Medical Center
Manila
Manila Doctors Hospital
Manila
Philippine General Hospital
Manila
St. Luke's Medical Center Global City
Manila
University of Santo Tomas
Manila
The Medical City
Pasig
East Avenue Medical Center
Quezon City
National Kidney and Transplant Institute
Quezon City
Quirino Memorial Medical Center
Quezon City
St. Luke's Medical Center
Quezon City
Jose B.Lingad Memorial Regional Memorial Hspl
San Fernando City
Thailand10 sites
Bhumibol Adulyadej Hospital
Bangkok
King Chulalongkorn Memorial Hospital
Bangkok
Rajavithi Hospital
Bangkok
Ramathibodi Hospital
Bangkok
Srinakarin Hospital
Bangkok
Thammasat University Hospital
Bangkok
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai
Songkla Nakarin Hospital
Hat Yai
Siriraj Hospital
Phuket
Surin Hospital
Surin
Indonesia9 sites
Cipto Mangunkusumo Hospital
Jakarta
Dharmais Cancer Center
Jakarta
Rumah Sakit Persahabatan
Jakarta
Siloam Hospitals Kebon Jeruk
Jeruk
Kariadi Hospital
Semarang
Telogorejo Hospital
Semarang
Mitra Keluarga Waru Hospital
Waru
Bethesda Hospital
Yogyakarta
Sardjito Hospital
Yogyakarta
South Korea9 sites
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Hospital
Daegu
National Cancer Center
Goyang-si
Chungnam National University Hospital
Jungnam
Seoul National University Bundang Hospital
Seoul
Seoul National University Hospital
Seoul
Sungkunkwan University Samsung Medical Center
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Ulsan University Hospital, Asan Medical Center
Ulsan
Taiwan9 sites
Changhua Christian Medical Foundation Changhua Christian Hospital
Chang-hua
Chang Gung Memorial Hospital- Kaoshiung Branch
Kaohsiung City
E-DA Hospital
Kaohsiung City
Kaohsiung Veterans General Hospital
Kaohsiung City
Chang Gung Memorial Hospital
Linkou District
Chung Shan Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Vietnam7 sites
108 Military Central Hospital
Hanoi
Bach Mai Hospital
Hanoi
Cho Ray Hospital
Ho Chi Minh City
HCM city University Medical Center
Ho Chi Minh City
People's Hospital 115
Ho Chi Minh City
Thong Nhat Hospital
Ho Chi Minh City
Hue Central Hospital
Huế
About this study
Official title: Nutrition Insights Day Asia to Assess Hospital Malnutrition and the Routine Use of Enteral and Parenteral Nutrition in Patients Following Major Gastrointestinal Surgery
This is an observational, cross-sectional study to be conducted on the Nutrition Insights Day (NID), with retrospective review of patient medical charts. No prospective follow-up period is considered.
This study aims to obtain a contemporary overview of the nutritional status, the use of EN and/or PN and the provision of calories and proteins in patients after major elective gastrointestinal surgery with existing malnutrition or at risk of hospital malnutrition in selected Asian countries.
- Conditions
- Nutritional Status, Malnutrition, Caloric Deficit, Protein Deficiency
- Keywords
- nutritional status, malnutrition, energy intake, protein intake, ICU, surgical ward, hospital, enteral nutrition, parenteral nutrition, nutrition
- Medical subject headings
- Malnutrition, Protein Deficiency, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical patients | Adult patients after elective major abdominal gastrointestinal surgery with pre-existing malnutrition or who are at significant risk for malnutrition or nutrition-related complications, with indications for nutritional support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of surgical patients with a caloric / protein deficit receiving EN and/or PN on the day before the NID in selected Asian countries.
Caloric / protein deficit, i.e., difference between energy / protein target per day and actually administered energy/protein
Measured: On the day before the Nutrition Insights Day (day -1)
Secondary outcomes (4)
Absolute and relative caloric and protein balance
Absolute and relative caloric and protein balance
Measured: On the day before the Nutrition Insights Day (day -1)
Distribution within subcategories of caloric / protein balance
Distribution within subcategories of caloric / protein balance
Measured: On the day before the Nutrition Insights Day (day -1)
Cumulative (absolute/ relative) caloric and protein balance
Cumulative (absolute/ relative) caloric and protein balance
Measured: On the day before the Nutrition Insights Day (day -1)
Categorical, absolute and relative caloric balance based on standardized target intake (sensitivity analysis)
Categorical, absolute and relative caloric balance based on standardized
Measured: On the day before the Nutrition Insights Day (day -1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start15 Mar 2019
- Primary completion18 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Nutritional StatusStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 590 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- John F Stover, M.D., Study chair, Fresenius Kabi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606603
- Sponsor's protocol ID
- NScr-002-CNI
- Status last verified
- Jul 2019
- First submitted
- 23 Jul 2018
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Detsky AS, McLaughlin JR, Baker JP, Johnston N, Whittaker S, Mendelson RA, Jeejeebhoy KN. What is subjective global assessment of nutritional status? JPEN J Parenter Enteral Nutr. 1987 Jan-Feb;11(1):8-13. doi: 10.1177/014860718701100108.
PubMed 3820522Higashiguchi T, Arai H, Claytor LH, Kuzuya M, Kotani J, Lee SD, Michel JP, Nogami T, Peng N. Taking action against malnutrition in Asian healthcare settings: an initiative of a Northeast Asia Study Group. Asia Pac J Clin Nutr. 2017 Mar;26(2):202-211. doi: 10.6133/apjcn.022016.04.
PubMed 28244696Ho JW, Wu AH, Lee MW, Lau SY, Lam PS, Lau WS, Kwok SS, Kwan RY, Lam CF, Tam CK, Lee SO. Malnutrition risk predicts surgical outcomes in patients undergoing gastrointestinal operations: Results of a prospective study. Clin Nutr. 2015 Aug;34(4):679-84. doi: 10.1016/j.clnu.2014.07.012. Epub 2014 Aug 1.
PubMed 25175758Jia ZY, Yang J, Tong DN, Peng JY, Zhang ZW, Liu WJ, Xia Y, Qin HL. Screening of nutritional risk and nutritional support in general surgery patients: a survey from Shanghai, China. Int Surg. 2015 May;100(5):841-8. doi: 10.9738/INTSURG-D-14-00245.1.
PubMed 26011204Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.
PubMed 12765673Linthicum MT, Thornton Snider J, Vaithianathan R, Wu Y, LaVallee C, Lakdawalla DN, Benner JE, Philipson TJ. Economic burden of disease-associated malnutrition in China. Asia Pac J Public Health. 2015 May;27(4):407-17. doi: 10.1177/1010539514552702. Epub 2014 Oct 8.
PubMed 25301845Liu X, Xu P, Qiu H, Xu D, Li W, Zhan Y, Li Y, Chen Y, Zhou Z, Sun X. Preoperative Nutritional Deficiency Is a Useful Predictor of Postoperative Outcome in Patients Undergoing Curative Resection for Gastric Cancer. Transl Oncol. 2016 Dec;9(6):482-488. doi: 10.1016/j.tranon.2016.09.008. Epub 2016 Oct 24.
PubMed 27788388Nakahara S, Nguyen DH, Bui AT, Sugiyama M, Ichikawa M, Sakamoto T, Nakamura T. Perioperative nutrition management as an important component of surgical capacity in low- and middle-income countries. Trop Med Int Health. 2017 Jul;22(7):784-796. doi: 10.1111/tmi.12892. Epub 2017 Jun 13.
PubMed 28510990Norman K, Pichard C, Lochs H, Pirlich M. Prognostic impact of disease-related malnutrition. Clin Nutr. 2008 Feb;27(1):5-15. doi: 10.1016/j.clnu.2007.10.007. Epub 2007 Dec 3.
PubMed 18061312Sun Z, Kong XJ, Jing X, Deng RJ, Tian ZB. Nutritional Risk Screening 2002 as a Predictor of Postoperative Outcomes in Patients Undergoing Abdominal Surgery: A Systematic Review and Meta-Analysis of Prospective Cohort Studies. PLoS One. 2015 Jul 14;10(7):e0132857. doi: 10.1371/journal.pone.0132857. eCollection 2015.
PubMed 26172830Vallejo KP, Martinez CM, Matos Adames AA, Fuchs-Tarlovsky V, Nogales GCC, Paz RER, Perman MI, Correia MITD, Waitzberg DL. Current clinical nutrition practices in critically ill patients in Latin America: a multinational observational study. Crit Care. 2017 Aug 25;21(1):227. doi: 10.1186/s13054-017-1805-z.
PubMed 28841885Waitzberg DL, Caiaffa WT, Correia MI. Hospital malnutrition: the Brazilian national survey (IBRANUTRI): a study of 4000 patients. Nutrition. 2001 Jul-Aug;17(7-8):573-80. doi: 10.1016/s0899-9007(01)00573-1.
PubMed 11448575Zhong JX, Kang K, Shu XL. Effect of nutritional support on clinical outcomes in perioperative malnourished patients: a meta-analysis. Asia Pac J Clin Nutr. 2015;24(3):367-78. doi: 10.6133/apjcn.2015.24.3.20.
PubMed 26420176
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Insights Day Asia to Assess Hospital Malnutrition and the Routine Use of Enteral and Parenteral Nutrition in Patients Following Major Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT03606603
- Acronym / sponsor ID
- NScr-002-CNI
- Conditions
- Nutritional Status, Malnutrition, Caloric Deficit, Protein Deficiency
- Keywords
- nutritional status, malnutrition, energy intake, protein intake, ICU, surgical ward, hospital, enteral nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 590 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 18 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 31 Jul 2018 (actual)
- 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.
This is an observational, cross-sectional study to be conducted on the Nutrition Insights Day (NID), with retrospective review of patient medical charts. No prospective follow-up period is considered.
This study aims to obtain a contemporary overview of the nutritional status, the use of EN and/or PN and the provision of calories and proteins in patients after major elective gastrointestinal surgery with existing malnutrition or at risk of hospital malnutrition in selected Asian countries.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical patients | – | –Adult patients after elective major abdominal gastrointestinal surgery with pre-existing malnutrition or who are at significant risk for malnutrition or nutrition-related complications, with indications for nutritional support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients after elective major abdominal gastrointestinal surgery with pre-existing malnutrition or who are at significant risk for malnutrition or nutrition-related complications, with indications for nutritional support
Key inclusion criteria (5 listed)
- Adult patients after elective major abdominal gastrointestinal surgery [i.e. elective major GI resections, partial or total, especially for cancer, including: esophagectomy, gastrectomy, enterectomy (small bowel resection), colectomy, hepatectomy, pancreatectomy, resections for gall bladder or bile duct cancer (cholangiocarcinoma)] with pre-existing malnutrition or who are at significant risk for malnutrition or nutrition-related complications*, with indications for nutritional support
- Hospitalization on SICU or major surgical ward on the NID
- Use of EN (nutritional intake provided via tube feeding) and/or PN for at least one day before the NID
- If patient received oral nutrition (ON) or oral nutrition supplements (ONS) during the observational phase from day -5 to day -2, complete and reliable data of daily caloric and protein intake is available
- Latest surgical intervention ≤ 10 days before NID
Key exclusion criteria (4 listed)
- Patients with burn injuries
- Patients requiring postsurgical mechanical ventilation and sedation on the NID
- Patients receiving ON and/or ONS at any quantity on the day before the NID
- Patients requiring emergency procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of surgical patients with a caloric / protein deficit receiving EN and/or PN on the day before the NID in selected Asian countries.
Time frame: On the day before the Nutrition Insights Day (day -1)
Caloric / protein deficit, i.e., difference between energy / protein target per day and actually administered energy/protein
4 secondary outcomes
Absolute and relative caloric and protein balance
Time frame: On the day before the Nutrition Insights Day (day -1)
Distribution within subcategories of caloric / protein balance
Time frame: On the day before the Nutrition Insights Day (day -1)
Cumulative (absolute/ relative) caloric and protein balance
Time frame: On the day before the Nutrition Insights Day (day -1)
Categorical, absolute and relative caloric balance based on standardized target intake (sensitivity analysis)
Time frame: On the day before the Nutrition Insights Day (day -1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Results publication: PubMed 3820522Detsky AS, McLaughlin JR, Baker JP, Johnston N, Whittaker S, Mendelson RA, Jeejeebhoy KN. What is subjective global assessment of nutritional status? JPEN J Parenter Enteral Nutr. 1987 Jan-Feb;11(1):8-13. doi: 10.1177/014860718701100108.
- Results publication: PubMed 28244696Higashiguchi T, Arai H, Claytor LH, Kuzuya M, Kotani J, Lee SD, Michel JP, Nogami T, Peng N. Taking action against malnutrition in Asian healthcare settings: an initiative of a Northeast Asia Study Group. Asia Pac J Clin Nutr. 2017 Mar;26(2):202-211. doi: 10.6133/apjcn.022016.04.
- Results publication: PubMed 25175758Ho JW, Wu AH, Lee MW, Lau SY, Lam PS, Lau WS, Kwok SS, Kwan RY, Lam CF, Tam CK, Lee SO. Malnutrition risk predicts surgical outcomes in patients undergoing gastrointestinal operations: Results of a prospective study. Clin Nutr. 2015 Aug;34(4):679-84. doi: 10.1016/j.clnu.2014.07.012. Epub 2014 Aug 1.
- Results publication: PubMed 26011204Jia ZY, Yang J, Tong DN, Peng JY, Zhang ZW, Liu WJ, Xia Y, Qin HL. Screening of nutritional risk and nutritional support in general surgery patients: a survey from Shanghai, China. Int Surg. 2015 May;100(5):841-8. doi: 10.9738/INTSURG-D-14-00245.1.
- Results publication: PubMed 12765673Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.
- Results publication: PubMed 25301845Linthicum MT, Thornton Snider J, Vaithianathan R, Wu Y, LaVallee C, Lakdawalla DN, Benner JE, Philipson TJ. Economic burden of disease-associated malnutrition in China. Asia Pac J Public Health. 2015 May;27(4):407-17. doi: 10.1177/1010539514552702. Epub 2014 Oct 8.
- Results publication: PubMed 27788388Liu X, Xu P, Qiu H, Xu D, Li W, Zhan Y, Li Y, Chen Y, Zhou Z, Sun X. Preoperative Nutritional Deficiency Is a Useful Predictor of Postoperative Outcome in Patients Undergoing Curative Resection for Gastric Cancer. Transl Oncol. 2016 Dec;9(6):482-488. doi: 10.1016/j.tranon.2016.09.008. Epub 2016 Oct 24.
- Results publication: PubMed 28510990Nakahara S, Nguyen DH, Bui AT, Sugiyama M, Ichikawa M, Sakamoto T, Nakamura T. Perioperative nutrition management as an important component of surgical capacity in low- and middle-income countries. Trop Med Int Health. 2017 Jul;22(7):784-796. doi: 10.1111/tmi.12892. Epub 2017 Jun 13.
- Results publication: PubMed 18061312Norman K, Pichard C, Lochs H, Pirlich M. Prognostic impact of disease-related malnutrition. Clin Nutr. 2008 Feb;27(1):5-15. doi: 10.1016/j.clnu.2007.10.007. Epub 2007 Dec 3.
- Results publication: PubMed 26172830Sun Z, Kong XJ, Jing X, Deng RJ, Tian ZB. Nutritional Risk Screening 2002 as a Predictor of Postoperative Outcomes in Patients Undergoing Abdominal Surgery: A Systematic Review and Meta-Analysis of Prospective Cohort Studies. PLoS One. 2015 Jul 14;10(7):e0132857. doi: 10.1371/journal.pone.0132857. eCollection 2015.
- Results publication: PubMed 28841885Vallejo KP, Martinez CM, Matos Adames AA, Fuchs-Tarlovsky V, Nogales GCC, Paz RER, Perman MI, Correia MITD, Waitzberg DL. Current clinical nutrition practices in critically ill patients in Latin America: a multinational observational study. Crit Care. 2017 Aug 25;21(1):227. doi: 10.1186/s13054-017-1805-z.
- Results publication: PubMed 11448575Waitzberg DL, Caiaffa WT, Correia MI. Hospital malnutrition: the Brazilian national survey (IBRANUTRI): a study of 4000 patients. Nutrition. 2001 Jul-Aug;17(7-8):573-80. doi: 10.1016/s0899-9007(01)00573-1.
- Individual participant dataSharing planned: No
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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.
John F Stover, M.D. study chair
Fresenius Kabi
89 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Status and Malnutrition, run by Fresenius Kabi at 89 sites in 7 countries.
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 4 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 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 89 sites in India, Philippines, Thailand, Indonesia, South Korea and 2 more countries. 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 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?
Proportion of surgical patients with a caloric / protein deficit receiving EN and/or PN on the day before the NID in selected Asian countries. (time frame: On the day before the Nutrition Insights Day (day -1)). 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 NCT03606603, which also lists 13 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 5 Jul 2019.