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NCT Number: NCT07518095

Serum Bicarbonate and Enteral Feeding Intolerance in Adult ICU: 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enteral Nutrition Intolerance (EFI)

Other

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ilke dolğun

CONTACT

[email protected]

05555485632

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.