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

NCT07518095 | Not Yet Recruiting

• 1 other identifier: Göksu Tez
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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 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)

Outcome Measures

Primary Outcomes (1)

• 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.

  The first 72 hours following the initiation of enteral nutrition.

Interventions

Enteral Nutrition Intolerance (EFI) OTHER

The study investigates the development of EFI, characterized by symptoms like increased gastric residual volume, vomiting, and abdominal distension.

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 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Location

Related Publications (2)

• 1-Heyland DK et al. Incidence, Risk Factors, and Clinical Consequence of Enteral Feeding Intolerance in the Mechanically Ventilated Critically Ill. Critical Care Medicine, 2021.

  RESULT

• Reintam 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.

  PMID: 32414423 RESULT

MeSH Terms

Interventions

Ybx1 protein, rat

Central Study Contacts

ilke dolğun

CONTACT

05555485632; ilkeser2004@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

TU (1)