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Completed

NCT Number: NCT06134674

Early Versus Delayed Enteral Nutrition in Critically Ill Adults With COVID-19

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.

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Key information

Age range

19 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Collaborators

  • Baskent University

Registry information

Official study title

The Role of Early Enteral Nutrition in Critical Patients With COVID-19: A Retrospective Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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