NCT07802379 Gastric Emptying and Enteral Nutrition Tolerance According to Vasopressor Dose in ICU Patients

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 63 participants in total. It began in 2026-09 with a primary completion date of 2027-09.

Brief Summary

This study investigates whether the dose of vasopressor medications (drugs that maintain blood pressure in shock) affects gastric emptying during tube feeding in the intensive care unit (ICU). Critically ill patients receiving vasopressors often develop impaired gastric motility, which reduces the effectiveness of enteral nutrition and increases the risk of aspiration. Gastric emptying will be objectively measured using bedside point-of-care ultrasound - a safe, painless imaging method - at three time points: before feeding (T0), at 1 hour (T1), and at 2 hours (T2) after restarting enteral nutrition following a 2-hour fasting period. Patients will be stratified into three groups based on norepinephrine equivalent dose (NEQ): Group 1 (no vasopressor, NEQ=0), Group 2 (low-to-moderate dose, NEQ \>0 to \<0.3 μg/kg/min), and Group 3 (high dose, NEQ ≥0.3 μg/kg/min). The primary outcome is gastric emptying rate (GER = (T0 volume - T2 volume) / 2 hours). Gastroparesis is defined as GER ≤0 mL/hour. Secondary outcomes include antrum cross-sectional area, agreement between ultrasound and aspirated gastric residual volume (Bland-Altman analysis), and enteral nutrition intolerance incidence. A subgroup analysis by shock type (septic, cardiogenic, hypovolemic, obstructive) will also be performed. The study aims to identify the vasopressor dose threshold at which gastric emptying is significantly impaired, and to support the use of bedside gastric ultrasound as an objective, non-invasive monitoring tool for enteral nutrition management in the ICU.

Eligibility Criteria

Inclusion Criteria: * Age 18 years or older * Admitted to the intensive care unit * Receiving enteral nutrition via nasogastric or orogastric tube * At least 4 hours of uninterrupted enteral nutrition prior to measurement * At least 50% of daily caloric target achieved * No change in feeding rate in the last 2 hours * Written informed consent obtained from patient or legal representative Exclusion Criteria: * Age under 18 years * History of gastrectomy or upper gastrointestinal surgery * Known gastroparesis or diabetic gastropathy * Active gastrointestinal bleeding * Suspected bowel obstruction or perforation * Prokinetic agent use within the last 24 hours * BMI greater than 35 kg/m² * Pregnancy * Prone positioning more than 4 hours per day * Intra-abdominal pressure greater than 15 mmHg * Inadequate epigastric ultrasound window * Jejunostomy, gastrostomy, or post-pyloric feeding tube * Refusal of informed consent

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