[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654691":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":26,"studyPopulation":27,"armGroups":28,"interventions":22,"overallOfficials":22,"centralContacts":38,"locations":44,"responsibleParty":67,"collaborators":22,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":22,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":22,"enrollmentInfo":79,"targetDuration":82,"studyType":83,"phases":22,"briefSummary":84,"conditions":85,"keywords":91,"overallStatus":47,"whyStopped":22,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Başakşehir Çam & Sakura City Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Gastric Emptying Rate (GER)","Gastric emptying rate calculated as (T0 gastric volume - T2 gastric volume) \u002F 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\u002Fhour.","2 hours (from T0 baseline measurement to T2 measurement)",[14,18],{"measure":15,"description":16,"timeFrame":17},"Gastroparesis Incidence","The proportion of patients whose stomach fails to empty during the 2-hour feeding period (gastric emptying rate ≤0 mL\u002Fhour), compared across the three vasopressor dose groups.","2 hours",{"measure":19,"description":20,"timeFrame":21},"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\u002Fday) across vasopressor groups.","24 hours",null,{"allocation":22,"interventionModel":22,"interventionModelDescription":22,"primaryPurpose":22,"observationalModel":24,"timePerspective":25,"maskingInfo":22},"COHORT","PROSPECTIVE","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\u002Finotrope 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.\n\nPoint-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\u002F2) × (dCC\u002F2) in both supine and right lateral decubitus positions, and gastric volume is calculated using the Perlas formula (27 + 14.6 × CSA right lateral decubitus).\n\nMeasurement 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) \u002F 2 hours. Gastroparesis is defined as GER ≤0 mL\u002Fhour.\n\nAll 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.","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.",[29,32,35],{"label":30,"type":22,"description":31,"interventionNames":22},"Vasopressor-Free","ICU patients receiving enteral nutrition without any vasopressor or inotrope (NEQ = 0 μg\u002Fkg\u002Fmin)",{"label":33,"type":22,"description":34,"interventionNames":22},"Moderate Shock","ICU patients receiving enteral nutrition with low-to-moderate norepinephrine equivalent dose (NEQ \\>0 and \\\u003C0.3 μg\u002Fkg\u002Fmin)",{"label":36,"type":22,"description":37,"interventionNames":22},"Severe Shock","ICU patients receiving enteral nutrition with high norepinephrine equivalent dose (NEQ ≥0.3 μg\u002Fkg\u002Fmin)",[39],{"name":40,"role":41,"phone":42,"phoneExt":22,"email":43},"Rezan Şerefoğlu, M.D.","CONTACT","+90 212 909 6000","rezzan.ozcalimli@gmail.com",[45],{"facility":46,"status":47,"city":48,"state":22,"zip":49,"country":50,"countryCode":22,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Basaksehir Cam ve Sakura City Hospital","RECRUITING","Istanbul","34480","Turkey (Türkiye)",{"type":52,"coordinates":53},"Point",[54,55],28.94966,41.01384,{"lat":55,"lon":54},[58,59,62,65],{"name":40,"role":41,"phone":42,"phoneExt":22,"email":43},{"name":60,"role":61,"phone":22,"phoneExt":22,"email":22},"Rezan Şerefoğlu, M.D","PRINCIPAL_INVESTIGATOR",{"name":63,"role":64,"phone":22,"phoneExt":22,"email":22},"Kamuran Uluç, M.D.","SUB_INVESTIGATOR",{"name":66,"role":64,"phone":22,"phoneExt":22,"email":22},"Gülçin Hilal Alay, M.D.",{"type":61,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Rezan Serefoglu","Specialist Anaesthesiologist, Intensive Care Unit Fellow","100654691","gastric-emptying-and-enteral-nutrition-tolerance-according-to-vasopressor-dose-in-icu-patients-100654691",false,"NCT07802379","Gastric Emptying and Enteral Nutrition Tolerance According to Vasopressor Dose in ICU Patients","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","Inclusion Criteria:\n\n* Age 18 years or older\n* Admitted to the intensive care unit\n* Receiving enteral nutrition via nasogastric or orogastric tube\n* At least 4 hours of uninterrupted enteral nutrition prior to measurement\n* At least 50% of daily caloric target achieved\n* No change in feeding rate in the last 2 hours\n* Written informed consent obtained from patient or legal representative\n\nExclusion Criteria:\n\n* Age under 18 years\n* History of gastrectomy or upper gastrointestinal surgery\n* Known gastroparesis or diabetic gastropathy\n* Active gastrointestinal bleeding\n* Suspected bowel obstruction or perforation\n* Prokinetic agent use within the last 24 hours\n* BMI greater than 35 kg\u002Fm²\n* Pregnancy\n* Prone positioning more than 4 hours per day\n* Intra-abdominal pressure greater than 15 mmHg\n* Inadequate epigastric ultrasound window\n* Jejunostomy, gastrostomy, or post-pyloric feeding tube\n* Refusal of informed consent","ALL","18 Years",{"count":80,"type":81},63,"ESTIMATED","1 Day","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).\n\nCritically 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.\n\nPatients 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 \\\u003C0.3 μg\u002Fkg\u002Fmin), and Group 3 (high dose, NEQ ≥0.3 μg\u002Fkg\u002Fmin). The primary outcome is gastric emptying rate (GER = (T0 volume - T2 volume) \u002F 2 hours). Gastroparesis is defined as GER ≤0 mL\u002Fhour. 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.\n\nThe 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.",[86,87,88,89,90],"Gastroparesis","Shock","Critical Illness","Gastric Emptying","Enteral Nutrition Intolerance (EFI)",[92,93,94,95,96,97,98,99,100,86],"Gastric ultrasound","Point-of-care ultrasonography","Gastric emptying rate","Vasopressor","Norepinephrine","Antrum cross-sectional area","Gastric residual volume","Critical illness","Intensive care unit","2026-09-01",{"date":103,"type":104},"2026-09-03","ACTUAL",{"date":106,"type":81},"2026-09",{"date":108,"type":81},"2027-11",{"name":5,"class":6},1]