Serum Bicarbonate and Enteral Feeding Intolerance in Adult ICU: A Prospective Clinical Trial

April 1, 2026 updated by: İlke Dolgun, Istinye University

Serum Bicarbonate and Enteral Feeding Intolerance in Adult ICU Patients: A Prospective Clinical Trial

This prospective, observational study evaluates whether serum bicarbonate HCO3 levels can predict enteral nutrition intolerance (EFI) in adult ICU patients.Objective: To determine if lower HCO3 levels correlate with the development of EFI.Design: A 12-month study involving 70 participants at Sultangazi Haseki Training and Research Hospital.Methodology: Patients starting enteral nutrition within 48 hours of admission will be monitored for 72 hours. Daily HCo3 pH, and lactate levels will be recorded from routine morning blood draws.Hypothesis: Lower bicarbonate levels are an independent predictor of EFI development in critically ill patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

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

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Merkez Mahallesi
      • Istanbul, Merkez Mahallesi, Turkey (Türkiye), 34250
        • Istinye University

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

Probability Sample

Study Population

The study population consists of adult patients aged 18 and older who are admitted to the intensive care unit (ICU). This group specifically includes those who begin enteral nutrition (EN) within the first 48 hours of their ICU admission and are expected to remain in the unit for at least 72 hours. The target sample size is 70 participants, factoring in potential drop-outs to maintain statistical power. Certain clinical conditions are excluded to ensure data consistency, such as pregnancy, 18 years of age or younger, active gastrointestinal bleeding or perforation, and recent major abdominal surgery. Additionally, patients requiring specialized enteral formulas or those with advanced organ failure (e.g., Child-Pugh C liver failure or dialysis-dependent kidney failure) are not included in the study population.

Description

Inclusion Criteria:

  • Adult patients aged 18 and older.
  • Patients started on enteral nutrition (EN) within the first 48 hours of their intensive care unit admission.
  • Patients predicted to remain in the intensive care unit for at least 72 hours.
  • Patients (or their legal representatives) who have provided consent to participate in the study.

Exclusion Criteria:

  • Patients under the age of 18.Individuals who are currently pregnant or breastfeeding.
  • Patients with gastrointestinal (GI) perforation, active GI bleeding, or mechanical bowel obstruction.
  • Patients who have undergone major abdominal surgery (e.g., esophagectomy, gastrectomy) within the last month.
  • Patients receiving total parenteral nutrition (TPN) or those who are only fed orally.
  • Patients requiring specialized enteral formulas (e.g., diabetic, renal, immunomodulatory, elemental, or semi-elemental) due to clinical necessity.
  • Patients with a known diagnosis of diabetes or those with HbA1c >6.5 requiring a diabetic enteral formula.
  • Patients with terminal-stage malignancy or those requiring specific enteral nutrition protocols.
  • Patients with advanced (Child-Pugh C) liver failure.
  • Patients with chronic kidney failure requiring dialysis.
  • Patients with diabetic ketoacidosis, severe metabolic asidozis, or those requiring initial bicarbonate replacement.
  • Patients who are brain dead or in the palliative care stage.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The relationship between serum bicarbonate levels and enteral nutrition intolerance (EFI).
Time Frame: The first 72 hours following the initiation of enteral nutrition.
Evaluation of daily serum bicarbonate ($HCO_3^-$) levels as a predictor for the development of enteral nutrition intolerance in adult intensive care patients. This includes determining the most appropriate cut-off values, sensitivity, and specificity through ROC curve analysis.
The first 72 hours following the initiation of enteral nutrition.

Collaborators and Investigators

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

Sponsor

Istinye University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

April 15, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

January 15, 2027

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Göksu Tez

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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