An observational study in Gastroparesis, Shock and Critical Illness, sponsored by Başakşehir Çam & Sakura City Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Başakşehir Çam & Sakura City Hospital · Observational
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.
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.
323 studies on the registry are indexed under Gastroparesis; 76 are open to participants now.
This study's planned enrollment of 63 is below the median of 100 across 80 observational studies indexed under Gastroparesis.
Browse Gastroparesis studies →Başakşehir Çam & Sakura City Hospital is the lead sponsor of 109 studies on the registry; 36 are open to participants now.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ICU patients receiving enteral nutrition without any vasopressor or inotrope (NEQ = 0 μg/kg/min)
ICU patients receiving enteral nutrition with low-to-moderate norepinephrine equivalent dose (NEQ \>0 and \<0.3 μg/kg/min)
ICU patients receiving enteral nutrition with high norepinephrine equivalent dose (NEQ ≥0.3 μg/kg/min)
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)
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
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
Plan to share: No — Individual participant data will not be shared due to patient privacy and data confidentiality considerations in accordance with Turkish personal data protection legislation (KVKK No. 6698). Aggregate study results will be disseminated through peer-reviewed publication.
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 47 observational studies under Gastroparesis, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 142. This study's planned 12 months is below that.
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