About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age under 18 years
History of gastrectomy or upper gastrointestinal surgery
Known gastroparesis or diabetic gastropathy
Active gastrointestinal bleeding
Trial population
Adult ICU patients with shock of any etiology (septic, cardiogenic, hypovolemic, obstructive) receiving enteral nutrition via nasogastric or orogastric tube, with or without vasopressor therapy, admitted to Basaksehir Cam ve Sakura City Hospital ICU.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Gastric Emptying Rate (GER)
Gastric emptying rate calculated as (T0 gastric volume - T2 gastric volume) / 2 hours, measured by point-of-care gastric ultrasonography using the Perlas formula (27 + 14.6 × antrum CSA right lateral decubitus). Comparison across three vasopressor dose groups. Gastroparesis defined as GER ≤0 mL/hour.
Secondary outcomes
Gastroparesis Incidence
The proportion of patients whose stomach fails to empty during the 2-hour feeding period (gastric emptying rate ≤0 mL/hour), compared across the three vasopressor dose groups.
Enteral Nutrition Intolerance Incidence
Proportion of patients with feeding intolerance defined as GRV \>250 mL, regurgitation, aspiration pneumonia, abdominal distension, or diarrhea (\>3 loose stools/day) across vasopressor groups.
Sponsors and contacts
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