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Clinical Trials/NCT06134674
NCT06134674
Completed
Not Applicable

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

Ankara City Hospital Bilkent1 site in 1 country135 target enrollmentOctober 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Enteral Nutrition
Sponsor
Ankara City Hospital Bilkent
Enrollment
135
Locations
1
Primary Endpoint
Whether Nutritional goals were met, EN complications, and reasons for discontinuation and postponement.
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2021
End Date
November 20, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Selen Özsoy

Doctor of Philosophy

Ankara City Hospital Bilkent

Eligibility Criteria

Inclusion Criteria

  • patients diagnosed with COVID-19
  • aged 19 years and older
  • 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

Outcomes

Primary Outcomes

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.

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

Study Sites (1)

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