FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS | NCT07780734 | Trialant

Not yet recruitingObservationalUpdated Aug 21, 2026

FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS

FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS: A PROSPECTİVE OBSERVATİONAL STUDY

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07780734
Lead Sponsor: Eda Cirit BardakçiOTHER_GOV
Overall Status: Not yet recruiting
Study Type: Observational
Enrollment: 102Estimated
Last Update Posted: Aug 21, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Sep 1, 2026Estimated
Completion Date: Sep 15, 2026Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS: A PROSPECTİVE OBSERVATİONAL STUDY
Brief Summary: Enteral nutrition is the first-line nutritional support method in critically ill patients because it helps preserve gastrointestinal system integrity, reduce the risk of infection, and meet metabolic requirements. However, gastrointestinal motility is frequently impaired in critically ill patients due to physiological stress, hemodynamic instability, sedative and vasopressor medications, mechanical ventilation, and underlying diseases. This may result in enteral feeding intolerance (EFI), which complicates nutritional management.

This prospective observational study aims to determine the demographic, clinical, laboratory, and treatment-related factors associated with enteral feeding intolerance in adult intensive care unit patients and to evaluate the association between enteral feeding intolerance and morbidity and mortality.

Adult patients who are started on enteral nutrition in the Anesthesiology and Reanimation Intensive Care Unit will be prospectively followed. No additional intervention will be performed. Patients will be monitored according to routine intensive care and enteral nutrition protocols. Enteral feeding intolerance and potentially associated factors will be recorded prospectively.

The study is planned to include 102 patients.

Conditions

The medical conditions and diseases this study investigates.

Patients Who Receive Enteral Nutrition for at Least 72 Hours in the Intensive Care Unit Will be Included in the Study

Interventions

The treatments and procedures being evaluated in this study.

No interventions

There are no interventions for this study.

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Age ≥18 years

Admission to the Anesthesia Intensive Care Unit

Enteral nutrition planned or initiated during intensive care unit admission

Expected to require enteral nutrition during intensive care unit follow-up

Availability of sufficient clinical and nutritional data for study evaluation

Patient or legally authorized representative provides informed consent when required by the ethics protocol

Exclusion Criteria:

Age <18 years

Patients receiving only parenteral nutrition

Patients in whom enteral nutrition is contraindicated throughout the observation period

Patients with insufficient data for evaluation of enteral feeding tolerance

Patients transferred to another intensive care unit before adequate study assessment

Patients who decline participation or whose legally authorized representative declines participation when consent is required

Design

How the study is designed and how its participant groups are organized.

Observational Model: Other
Time Perspective: Prospective

Contacts

The people to reach with questions about this study or how to join it.

Eda Cirit Bardakci, Medical DoctorContact

edacrt@gmail.com+90 541 308 9295

Locations

Where the study is run and whether each site is currently recruiting.

No locations

There are no locations for this study.

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Eda Cirit BardakçiOTHER_GOV

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Other registered studies that closely resemble this one.

Detailed Description

Enteral nutrition is an important component of nutritional support in critically ill patients. However, enteral feeding intolerance is frequently observed in intensive care units and may result from impaired gastrointestinal motility associated with critical illness, hemodynamic instability, sedative and vasopressor use, mechanical ventilation, and underlying diseases.

In this study, demographic, clinical, laboratory, physiological, nutritional, and treatment-related variables that may affect the development of enteral feeding intolerance will be evaluated prospectively.

All adult patients admitted to the intensive care unit who are planned to receive enteral nutrition will be screened daily. Patients meeting the eligibility criteria will be enrolled after informed consent has been obtained from the patient or legally authorized representative.

Because this is an observational study, there will be no randomization and no investigator-assigned intervention. Patients will be classified according to their natural clinical course into an enteral feeding intolerance group and a non-enteral feeding intolerance group.

Demographic characteristics, admission diagnosis, APACHE II, SOFA, and Glasgow Coma Scale scores will be recorded. Daily clinical variables including bowel sounds, presence of stool, sedation, opioid use, vasopressor requirement, sepsis, and aspiration pneumonia will also be recorded.

Routine laboratory parameters including total protein, albumin, C-reactive protein, procalcitonin, lactate, hemoglobin, leukocyte count, and lymphocyte count will be obtained from the hospital electronic medical record twice weekly according to routine clinical practice.

The modified Nutrition Risk in Critically Ill (mNUTRIC) score and Prognostic Nutritional Index (PNI) will be calculated. Mechanical ventilation characteristics, enteral nutrition initiation time, formula type, daily energy and protein targets, delivered amounts, and interruptions of enteral nutrition will be recorded.

Enteral feeding intolerance will be assessed according to predefined criteria and international recommendations. The following findings will be considered enteral feeding intolerance: vomiting, a single gastric residual volume greater than 250 mL, a 24-hour gastric residual volume greater than 500 mL, abdominal distension, and suspected aspiration.

Gastric residual volume will be measured by intensive care nurses using a 50-mL syringe according to the standard intensive care unit protocol.

Intra-abdominal pressure will be measured twice weekly as part of routine intensive care practice using the Foley bladder pressure measurement technique.

All study data will be obtained from routine clinical records, laboratory results, enteral nutrition monitoring charts, ventilator records, and the hospital electronic medical record. No additional invasive procedure, imaging study, surgical procedure, or other intervention will be performed for research purposes.