GastroparesisNCT07802379
Gastric Emptying and Enteral Nutrition Tolerance According to Vasopressor Dose in ICU Patients
An observational study of Gastroparesis and Shock, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis, Shock, Critical Illness
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2026to Nov 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Basaksehir Cam ve Sakura City Hospital
Istanbul, 34480
Rezan Şerefoğlu, M.D., +90 212 909 6000, rezzan.ozcalimli@gmail.com
Rezan Şerefoğlu, M.D
About this study
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
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.
Read more
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.
Read the detailed description
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.
- 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
- Medical subject headings
- Gastroparesis, Shock, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours (from T0 baseline measurement to T2 measurement)
Secondary outcomes (2)
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.
Measured: 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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rezan Serefoglu, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802379
- Sponsor's protocol ID
- E-96317027-514.10-321014619
- Other IDs
- KAEK-11/08.07.2026.252
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 34599691Wang 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.
PubMed 36558552Perlas 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.
PubMed 19512861
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07802379
- Acronym / sponsor ID
- E-96317027-514.10-321014619
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- Age under 18 years
- History of gastrectomy or upper gastrointestinal surgery
- Known gastroparesis or diabetic gastropathy
- Active gastrointestinal bleeding
- Suspected bowel obstruction or perforation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gastric Emptying Rate (GER)
Time frame: 2 hours (from T0 baseline measurement to T2 measurement)
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 secondary outcomes
Gastroparesis Incidence
Time frame: 2 hours
Enteral Nutrition Intolerance Incidence
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Background: PubMed 34599691Evans 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.
- Background: PubMed 36558552Wang 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.
- Background: PubMed 19512861Perlas 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroparesis and Shock, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rezan Şerefoğlu, M.D. (+90 212 909 6000, rezzan.ozcalimli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric Emptying Rate (GER) (time frame: 2 hours (from T0 baseline measurement to T2 measurement)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07802379, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.