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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• The relationship between serum bicarbonate levels and enteral nutrition intolerance (EFI). [Срок оценки: The first 72 hours following the initiation of enteral nutrition.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Istinye Üniversity — Istanbul

Публикации

• 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

Идентификаторы

NCT: NCT07518095 · Göksu Tez

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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