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

November 12, 2023 updated by: Selen Özsoy, Ankara City Hospital Bilkent

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06800
        • Ankara City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Collaborators

Baskent University

Investigators

  • Principal Investigator: Selen Özsoy, PHD, Ankara City Hospital Bilkent
  • Study Director: Mendane Saka, Prof.Dr., Başkent University
  • Principal Investigator: Levent Öztürk, Prof.Dr., Ankara Yildirim Beyazıt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2021

Primary Completion (Actual)

October 15, 2022

Study Completion (Actual)

November 20, 2022

Study Registration Dates

First Submitted

November 9, 2023

First Submitted That Met QC Criteria

November 12, 2023

First Posted (Estimated)

November 16, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 12, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnkaraCHBilkent-NUTR-EEN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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