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

NCT07802379 | Recruiting

• 2 other identifiers: E-96317027-514.10-321014619KAEK-11/08.07.2026.252
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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

Outcome Measures

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.

  2 hours (from T0 baseline measurement to T2 measurement)

Secondary Outcomes (2)

• Gastroparesis Incidence

  2 hours

• Enteral Nutrition Intolerance Incidence

  24 hours

Study Arms (3)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Basaksehir Cam ve Sakura City Hospital

Istanbul, 34480, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.

  PMID: 34599691 BACKGROUND

• Wang L, Zhang T, Yao H, Xu Q, Fu X, Yang J, Wang B, Zhang Z, Jin X, Kang Y, Wu Q. Association of Vasopressors Dose Trajectories with Enteral Nutrition Tolerance in Patients with Shock: A Prospective Observational Study. Nutrients. 2022 Dec 19;14(24):5393. doi: 10.3390/nu14245393.

  PMID: 36558552 BACKGROUND

• Perlas A, Chan VW, Lupu CM, Mitsakakis N, Hanbidge A. Ultrasound assessment of gastric content and volume. Anesthesiology. 2009 Jul;111(1):82-9. doi: 10.1097/ALN.0b013e3181a97250.

  PMID: 19512861 BACKGROUND

MeSH Terms

Conditions

Gastroparesis; Shock; Critical Illness

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Disease Attributes

Central Study Contacts

Rezan Şerefoğlu, M.D.

CONTACT

+90 212 909 6000; rezzan.ozcalimli@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Anaesthesiologist, Intensive Care Unit Fellow

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 3, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 3, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)