Gastroparesis Clinical Trials

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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
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Basaksehir Cam ve Sakura City Hospital
RECRUITING
Istanbul
Contact Information
Primary
Rezan Şerefoğlu, M.D.
rezzan.ozcalimli@gmail.com
+90 212 909 6000
Time Frame
Start Date: 2026-09
Estimated Completion Date: 2027-11
Participants
Target number of participants: 63
Treatments
Vasopressor-Free
ICU patients receiving enteral nutrition without any vasopressor or inotrope (NEQ = 0 μg/kg/min)
Moderate Shock
ICU patients receiving enteral nutrition with low-to-moderate norepinephrine equivalent dose (NEQ \>0 and \<0.3 μg/kg/min)
Severe Shock
ICU patients receiving enteral nutrition with high norepinephrine equivalent dose (NEQ ≥0.3 μg/kg/min)
Related Therapeutic Areas
Sponsors
Leads: Başakşehir Çam & Sakura City Hospital

This content was sourced from clinicaltrials.gov