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RECRUITING
NCT07802379

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

Sponsor: Başakşehir Çam & Sakura City Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

63

Start Date

2026-09

Completion Date

2027-11

Last Updated

2026-09-03

Healthy Volunteers

No

Locations (1)

Basaksehir Cam ve Sakura City Hospital

Istanbul, Turkey (Türkiye)