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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBaşakşehir Çam & Sakura City Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

63 Participants
are grouped into 3 trial groups
Group A: Vasopressor-Free
Group B: Moderate Shock
Group C: Severe Shock

Trial outcomes

Primary outcomes

1

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.

Time frame
2 hours (from T0 baseline measurement to T2 measurement)

Secondary outcomes

1

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.

Time frame
2 hours
2

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.

Time frame
24 hours

Other outcomes

Sponsors and contacts

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