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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istinye University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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