Enteral Nutrition Intolerance (EFI)NCT07518095
Serum Bicarbonate and Enteral Feeding Intolerance in Adult ICU: A Prospective Clinical Trial
An observational study of Enteral Nutrition Intolerance (EFI), run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Nutrition Intolerance (EFI)
- What is being tested?
- Enteral Nutrition Intolerance (EFI)
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2026to 15 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istinye Üniversity
Istanbul, Merkez Mahallesi, 34250
About this study
Official title: 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.
- Conditions
- Enteral Nutrition Intolerance (EFI)
- Being tested
- Enteral Nutrition Intolerance (EFI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral Nutrition Intolerance (EFI)Other
The study investigates the development of EFI, characterized by symptoms like increased gastric residual volume, vomiting, and abdominal distension.
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between serum bicarbonate levels and enteral nutrition intolerance (EFI).
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.
Measured: The first 72 hours following the initiation of enteral nutrition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Enteral Nutrition Intolerance (EFI)Studies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518095
- Sponsor's protocol ID
- Göksu Tez
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heyland DK, Ortiz A, Stoppe C, Patel JJ, Yeh DD, Dukes G, Chen YJ, Almansa C, Day AG. Incidence, Risk Factors, and Clinical Consequence of Enteral Feeding Intolerance in the Mechanically Ventilated Critically Ill: An Analysis of a Multicenter, Multiyear Database. Crit Care Med. 2021 Jan 1;49(1):49-59. doi: 10.1097/CCM.0000000000004712.
PubMed 33148950Reintam Blaser A, Preiser JC, Fruhwald S, Wilmer A, Wernerman J, Benstoem C, Casaer MP, Starkopf J, van Zanten A, Rooyackers O, Jakob SM, Loudet CI, Bear DE, Elke G, Kott M, Lautenschlager I, Schaper J, Gunst J, Stoppe C, Nobile L, Fuhrmann V, Berger MM, Oudemans-van Straaten HM, Arabi YM, Deane AM; Working Group on Gastrointestinal Function within the Section of Metabolism, Endocrinology and Nutrition (MEN Section) of ESICM. Gastrointestinal dysfunction in the critically ill: a systematic scoping review and research agenda proposed by the Section of Metabolism, Endocrinology and Nutrition of the European Society of Intensive Care Medicine. Crit Care. 2020 May 15;24(1):224. doi: 10.1186/s13054-020-02889-4.
PubMed 32414423
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Bicarbonate and Enteral Feeding Intolerance in Adult ICU Patients: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT07518095
- Acronym / sponsor ID
- Göksu Tez
- Conditions
- Enteral Nutrition Intolerance (EFI)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteral Nutrition Intolerance (EFI)The study investigates the development of EFI, characterized by symptoms like increased gastric residual volume, vomiting, and abdominal distension. | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Results publication: PubMed 33148950Heyland DK, Ortiz A, Stoppe C, Patel JJ, Yeh DD, Dukes G, Chen YJ, Almansa C, Day AG. Incidence, Risk Factors, and Clinical Consequence of Enteral Feeding Intolerance in the Mechanically Ventilated Critically Ill: An Analysis of a Multicenter, Multiyear Database. Crit Care Med. 2021 Jan 1;49(1):49-59. doi: 10.1097/CCM.0000000000004712.
- Results publication: PubMed 32414423Reintam Blaser A, Preiser JC, Fruhwald S, Wilmer A, Wernerman J, Benstoem C, Casaer MP, Starkopf J, van Zanten A, Rooyackers O, Jakob SM, Loudet CI, Bear DE, Elke G, Kott M, Lautenschlager I, Schaper J, Gunst J, Stoppe C, Nobile L, Fuhrmann V, Berger MM, Oudemans-van Straaten HM, Arabi YM, Deane AM; Working Group on Gastrointestinal Function within the Section of Metabolism, Endocrinology and Nutrition (MEN Section) of ESICM. Gastrointestinal dysfunction in the critically ill: a systematic scoping review and research agenda proposed by the Section of Metabolism, Endocrinology and Nutrition of the European Society of Intensive Care Medicine. Crit Care. 2020 May 15;24(1):224. doi: 10.1186/s13054-020-02889-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enteral Nutrition Intolerance (EFI), run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ilke dolğun (05555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between serum bicarbonate levels and enteral nutrition intolerance (EFI). (time frame: The first 72 hours following the initiation of enteral nutrition.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07518095, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.