NCT Number: NCT07802379
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Istanbul, 34480, Turkey (Türkiye)
Location status: Recruiting
Gülçin Hilal Alay, M.D.
SUB_INVESTIGATOR
Kamuran Uluç, M.D.
SUB_INVESTIGATOR
Rezan Şerefoğlu, M.D
PRINCIPAL_INVESTIGATOR
Rezan Şerefoğlu, M.D.
CONTACT
Enteral nutrition (EN) is a cornerstone of critical care management; however, feeding intolerance occurs in 30-60% of ICU patients and is associated with prolonged ICU stay and increased mortality. Vasopressor/inotrope use is a recognized risk factor for impaired gastric motility, yet the dose-dependent relationship between vasopressor dosing and objective gastric emptying measurements remains poorly characterized. Existing studies rely primarily on clinical intolerance criteria rather than objective, non-invasive gastric emptying assessments.
Point-of-care gastric ultrasonography (POCUS) is a validated, non-invasive bedside method for assessing gastric content and volume. Antrum cross-sectional area (CSA) is measured using the formula π × (dAP/2) × (dCC/2) in both supine and right lateral decubitus positions, and gastric volume is calculated using the Perlas formula (27 + 14.6 × CSA right lateral decubitus).
Measurement Protocol (Protocol B): Enteral nutrition is stopped 2 hours before measurement. At T0 (baseline, 06:00-08:00), gastric ultrasound is performed first, followed immediately by nasogastric aspiration to record gastric residual volume (GRV). Enteral nutrition is then restarted, and ultrasound measurements are repeated at T1 (+1 hour) and T2 (+2 hours). Gastric emptying rate (GER) is calculated as (T0 volume - T2 volume) / 2 hours. Gastroparesis is defined as GER ≤0 mL/hour.
All ultrasound measurements are performed by a single blinded ICU fellow with ≥1 year of gastric ultrasound experience, who is unaware of the patient's vasopressor group, NEQ dose, and clinical data. Intraobserver reliability will be assessed during the first month (pilot phase) using intraclass correlation coefficient (ICC), with ICC >0.80 considered acceptable.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 hours (from T0 baseline measurement to T2 measurement)
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.
Time frame: 2 hours
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.
Time frame: 24 hours
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.
Contact information is provided by the study sponsor or research team.
Başakşehir Çam & Sakura City Hospital
Other Gov
Point-of-Care Gastric Ultrasonography for Objective Assessment of Gastric Emptying Rate and Enteral Nutrition Tolerance According to Vasopressor Dose in Critically Ill Patients: A Prospective Observational Cohort Study
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