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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07518095
Enrollment
70
Registered
2026-04-08
Start date
2026-04-15
Completion date
2027-01-15
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteral Nutrition Intolerance (EFI)

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.

Interventions

OTHEREnteral Nutrition Intolerance (EFI)

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

Sponsors

Istinye University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
The relationship between serum bicarbonate levels and enteral nutrition intolerance (EFI).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.

Countries

Turkey (Türkiye)

Contacts

CONTACTilke dolğun
ilkeser2004@gmail.com05555485632

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026