Serum Bicarbonate and Enteral Feeding Intolerance in Adult ICU: A Prospective Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enteral Nutrition Intolerance (EFI).
- Who it may be relevant to
- Registry conditions: Enteral Nutrition Intolerance (EFI). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Serum Bicarbonate and Enteral Feeding Intolerance in Adult ICU Patients: A Prospective Clinical Trial
Overview
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
- Other Enteral Nutrition Intolerance (EFI)
The study investigates the development of EFI, characterized by symptoms like increased gastric residual volume, vomiting, and abdominal distension.
Primary outcome measures
- The relationship between serum bicarbonate levels and enteral nutrition intolerance (EFI). [Time frame: The first 72 hours following the initiation of enteral nutrition.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Istinye Üniversity — Istanbul
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. PMID 33148950
- 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 Nutr PMID 32414423
Identifiers
NCT: NCT07518095 · Göksu Tez