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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07802379
Enrollment
63
Registered
2026-09-03
Start date
2026-09-01
Completion date
2027-11-01
Last updated
2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Enteral Nutrition Intolerance (EFI), Gastric Emptying, Gastroparesis, Shock

Keywords

Gastric ultrasound, Point-of-care ultrasonography, Gastric emptying rate, Vasopressor, Norepinephrine, Antrum cross-sectional area, Gastric residual volume, Critical illness, Intensive care unit, Gastroparesis

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.

Detailed description

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.

Interventions

None listed

Sponsors

Başakşehir Çam & Sakura City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Gastric Emptying Rate (GER)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.

Secondary

MeasureTime frameDescription
Gastroparesis Incidence2 hoursThe 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 Incidence24 hoursProportion of patients with feeding intolerance defined as GRV \>250 mL, regurgitation, aspiration pneumonia, abdominal distension, or diarrhea (\>3 loose stools/day) across vasopressor groups.

Countries

Turkey (Türkiye)

Contacts

CONTACTRezan Şerefoğlu, M.D.
rezzan.ozcalimli@gmail.com+90 212 909 6000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026