Enteral NutritionNCT06134674
Early Versus Delayed Enteral Nutrition in Critically Ill Adults With COVID-19
An observational study of Enteral Nutrition and COVID-19 Acute Respiratory Distress Syndrome, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to determine the relationship between the nutritional profile of critically ill patients diagnosed with COVID-19 and disease severity, prognosis, and survival, to assess the ability to meet nutritional goals, EN complications, and reasons for discontinuation and postponement of… Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Enteral Nutrition, COVID-19 Acute Respiratory Distress Syndrome
- How many people
- 135 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2021to 20 Nov 2022
- 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 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective study was conducted in a 3rd line ICU. The study included adult patients diagnosed with COVID-19, aged 19 years and older, on MV, and receiving enteral tube nutrition.
Who may be able to join
- patients diagnosed with COVID-19
- aged 19 years and older
- on MV
- receiving only enteral tube nutrition
Who cannot join
- patients with an inflammatory disease
- myocardial infarction, collapse, and circulatory shock within the last 6 months
- hemodynamic instability
- embolism and stroke
- presence of unspecified coma
- renal disease
Show all 13Show fewer
- cancer with a mortality rate of more than 50% within 6 months
- allogeneic bone marrow transplantation within 5 years
- enteral nutrition was contraindicated
- patients with allergic reactions to the enteral formula
- patients who received antioxidant supplements during feeding
- patients who received tube feeding supplemented with immunonutrition agents
- patients whose data could not be accurately retrieved
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Early Enteral Nutrition in Critical Patients With COVID-19: A Retrospective Study
The goal of this observational study is to determine the relationship between the nutritional profile of critically ill patients diagnosed with COVID-19 and disease severity, prognosis, and survival, to assess the ability to meet nutritional goals, EN complications, and reasons for discontinuation and postponement of feeding.
The main questions aim to answer are the relationship between the duration of EN initiation and Prognostic Nutritional Index (PNI) score, neutrophil-lymphocyte ratio (NLR), oxygenation status, MV, ICU, and length of hospital stay, overall mortality, and whether nutritional goals were met, EN complications, and reasons for discontinuation and postponement.
Read the detailed description
Nutritional support is a crucial component of managing critically ill patients. The prognostic impact of early enteral nutrition (EN) in critically ill COVID-19 patients is largely unknown. The study aimed to determine the relationship between the nutritional profile of critically ill patients diagnosed with COVID-19 and disease severity, prognosis, and survival, to assess the ability to meet nutritional goals, EN complications, and reasons for discontinuation and postponement of feeding. Methods: This retrospective study was conducted with adult intensive care unit (ICU) patients diagnosed with COVID-19 and receiving mechanical ventilation (MV) and EN. The demographic, clinical, biochemical, and nutritional data of the patients were obtained from the patient's files and the hospital database. The initiation time, route, method, product type, amount, and duration of feeding were recorded, and the daily intake of energy, protein, pulp, and water were calculated. The nutritional requirements of the patients were defined, and achievement of targets, EN complications, and reasons for discontinuation and postponement were recorded. Patients were divided into two groups: early EN (EEN) if the feeding was initiated within the first 48 hours after MV and late EN (LEN) if 48 hours or later. The research outcomes are to determine the relationship between the duration of EN initiation and Prognostic Nutritional Index (PNI) score, neutrophil-lymphocyte ratio (NLR), oxygenation status, MV, ICU, and length of hospital stay, overall mortality, and whether nutritional goals were met, EN complications, and reasons for discontinuation and postponement.
- Keywords
- SARS-COV-2,COVID-19,intensive care unit,early enteral nutrition
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 |
|---|---|---|
| Early Enteral Nutrition | Patients who received enteral nutrition within the first 48 hours following intubation were included in the Early Enteral Nutrition (EEN) group. | |
| Late Enteral Nutrition | Patients who received enteral nutrition 48 hours or later following intubation were included in the late Enteral Nutrition (LEN) group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
mechanical ventilation (MV), intensive care unit (ICU), length of hospital stay and overall mortality.
The research outcomes are to determine the relationship between the duration of EN initiation and MV, ICU, and length of hospital stay, overall mortality.
Measured: through study completion, an average of 9 months
Prognostic Nutritional Index (PNI) score, neutrophil-lymphocyte ratio (NLR), oxygenation status
The research outcomes are to determine the relationship between the duration of EN initiation and Prognostic Nutritional Index (PNI) score, neutrophil-lymphocyte ratio (NLR), oxygenation status
Measured: From date of hospitalization and intubation until the date of extubation or date of death from any cause, whichever came first, assessed up to 9 months
Whether Nutritional goals were met, EN complications, and reasons for discontinuation and postponement.
The research outcomes are to determine the relationship between the duration of EN initation and nutritional goals were met, EN complications, and reasons for discontinuation and postponement.
Measured: From date of intubation until the date of extubation or date of death from any cause, whichever came first, assessed up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start20 Oct 2021
- Primary completion15 Oct 2022
- Study completion20 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteral NutritionStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Collaborators
- Baskent University
- Responsible party
- Principal investigator, Selen Özsoy, Ankara City Hospital Bilkent
- Investigators
- Selen Özsoy, PHD, Principal investigator, Ankara City Hospital BilkentMendane Saka, Prof.Dr., Study director, Baskent UniversityLevent Öztürk, Prof.Dr., Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134674
- Sponsor's protocol ID
- AnkaraCHBilkent-NUTR-EEN
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Early Enteral Nutrition in Critical Patients With COVID-19: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06134674
- Acronym / sponsor ID
- AnkaraCHBilkent-NUTR-EEN
- Keywords
- SARS-COV-2,COVID-19,intensive care unit,early enteral nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Collaborators
- Baskent University
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 18 Nov 2023 (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.
The goal of this observational study is to determine the relationship between the nutritional profile of critically ill patients diagnosed with COVID-19 and disease severity, prognosis, and survival, to assess the ability to meet nutritional goals, EN complications, and reasons for discontinuation and postponement of feeding.
The main questions aim to answer are the relationship between the duration of EN initiation and Prognostic Nutritional Index (PNI) score, neutrophil-lymphocyte ratio (NLR), oxygenation status, MV, ICU, and length of hospital stay, overall mortality, and whether nutritional goals were met, EN complications, and reasons for discontinuation and postponement.
Detailed description
Nutritional support is a crucial component of managing critically ill patients. The prognostic impact of early enteral nutrition (EN) in critically ill COVID-19 patients is largely unknown. The study aimed to determine the relationship between the nutritional profile of critically ill patients diagnosed with COVID-19 and disease severity, prognosis, and survival, to assess the ability to meet nutritional goals, EN complications, and reasons for discontinuation and postponement of feeding. Methods: This retrospective study was conducted with adult intensive care unit (ICU) patients diagnosed with COVID-19 and receiving mechanical ventilation (MV) and EN. The demographic, clinical, biochemical, and nutritional data of the patients were obtained from the patient's files and the hospital database. The initiation time, route, method, product type, amount, and duration of feeding were recorded, and the daily intake of energy, protein, pulp, and water were calculated. The nutritional requirements of the patients were defined, and achievement of targets, EN complications, and reasons for discontinuation and postponement were recorded. Patients were divided into two groups: early EN (EEN) if the feeding was initiated within the first 48 hours after MV and late EN (LEN) if 48 hours or later. The research outcomes are to determine the relationship between the duration of EN initiation and Prognostic Nutritional Index (PNI) score, neutrophil-lymphocyte ratio (NLR), oxygenation status, MV, ICU, and length of hospital stay, overall mortality, and whether nutritional goals were met, EN complications, and reasons for discontinuation and postponement.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Enteral Nutrition | – | –Patients who received enteral nutrition within the first 48 hours following intubation were included in the Early Enteral Nutrition (EEN) group. |
| Late Enteral Nutrition | – | –Patients who received enteral nutrition 48 hours or later following intubation were included in the late Enteral Nutrition (LEN) group. |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study was conducted in a 3rd line ICU. The study included adult patients diagnosed with COVID-19, aged 19 years and older, on MV, and receiving enteral tube nutrition.
Key inclusion criteria (4 listed)
- patients diagnosed with COVID-19
- aged 19 years and older
- on MV
- receiving only enteral tube nutrition
Key exclusion criteria (13 listed)
- patients with an inflammatory disease
- myocardial infarction, collapse, and circulatory shock within the last 6 months
- hemodynamic instability
- embolism and stroke
- presence of unspecified coma
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
mechanical ventilation (MV), intensive care unit (ICU), length of hospital stay and overall mortality.
Time frame: through study completion, an average of 9 months
The research outcomes are to determine the relationship between the duration of EN initiation and MV, ICU, and length of hospital stay, overall mortality.
Prognostic Nutritional Index (PNI) score, neutrophil-lymphocyte ratio (NLR), oxygenation status
Time frame: From date of hospitalization and intubation until the date of extubation or date of death from any cause, whichever came first, assessed up to 9 months
The research outcomes are to determine the relationship between the duration of EN initiation and Prognostic Nutritional Index (PNI) score, neutrophil-lymphocyte ratio (NLR), oxygenation status
Whether Nutritional goals were met, EN complications, and reasons for discontinuation and postponement.
Time frame: From date of intubation until the date of extubation or date of death from any cause, whichever came first, assessed up to 9 months
The research outcomes are to determine the relationship between the duration of EN initation and nutritional goals were met, EN complications, and reasons for discontinuation and postponement.
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 18 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Enteral Nutrition
RecruitingPhase 3
Canadian Critical Care Comparative Effectiveness Platform
Intensive Care Unit ICU, Vasopressor
Not yet recruitingObservational study
FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS
Patients Who Receive Enteral Nutrition for at Least 72 Hours in the Intensive Care Unit Will be Included in the Study
Enrolling by invitation
Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
Crohn's Disease, Active
Not yet recruiting
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
Bronchiolitis, Clinical Phenotype
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
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.
Selen Özsoy, PHD principal investigator
Ankara City Hospital Bilkent
Mendane Saka, Prof.Dr. study director
Baskent University
Levent Öztürk, Prof.Dr. principal investigator
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enteral Nutrition and COVID-19 Acute Respiratory Distress Syndrome, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 4 inclusion and 13 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
mechanical ventilation (MV), intensive care unit (ICU), length of hospital stay and overall mortality. (time frame: through study completion, an average of 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.