FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS

NCT07780734 | Not Yet Recruiting

• 1 other identifier: 2024-BCEK/483
• Study Type: observational
• Target: 102
• Locations: 0 countries
• Sites: N/A

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

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

Keywords

Enteral Nutrition, Enteral Feeding Intolerance, Intensive Care Unit,

Outcome Measures

Primary Outcomes (1)

• Occurrence of Enteral Feeding Intolerance

  Enteral feeding intolerance will be defined by the presence of at least one predefined clinical criterion: vomiting, a single gastric residual volume greater than 250 mL, 24-hour cumulative gastric residual volume greater than 500 mL, abdominal distension, or clinical suspicion of aspiration related to enteral feeding.

  7 days

Secondary Outcomes (1)

• Achievement of Energy Target

  3 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will consist of adult patients aged 18 years or older who are admitted to the Anesthesiology and Reanimation Intensive Care Unit of Ankara Atatürk Sanatoryum Training and Research Hospital and who are started on enteral nutrition. Patients will be prospectively screened and consecutively enrolled if they meet all inclusion criteria and none of the exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eda Cirit Bardakçi: lead

Central Study Contacts

Eda Cirit Bardakci, Medical Doctor

CONTACT

+90 541 308 9295; edacrt@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 21, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share