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Clinical Trials in Turkey / NCT07518095
Starting soon Observational

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

NCT07518095 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-04-15
Last updated
2026-04-08

Condition(s) studied

Enteral Nutrition Intolerance (EFI)

Investigational drug(s) / intervention(s)

Enteral Nutrition Intolerance (EFI)

Enteral Nutrition Intolerance (EFI): The study investigates the development of EFI, characterized by symptoms like increased gastric residual volume, vomiting, and abdominal distension.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Istinye Üniversity Istanbul Merkez Mahallesi

More Istinye University trials in Turkey

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07518095 on ClinicalTrials.gov ↗ ← All trials in Turkey