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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06134674
Other study ID # AnkaraCHBilkent-NUTR-EEN
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 20, 2021
Est. completion date November 20, 2022

Study information

Verified date November 2023
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 135
Est. completion date November 20, 2022
Est. primary completion date October 15, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years to 100 Years
Eligibility Inclusion Criteria: - patients diagnosed with COVID-19 - aged 19 years and older - on MV - receiving only enteral tube nutrition Exclusion Criteria: - 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 - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Ankara City Hospital Ankara

Sponsors (2)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. through study completion, an average of 9 months
Primary 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 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
Primary 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. From date of intubation until the date of extubation or date of death from any cause, whichever came first, assessed up to 9 months