[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652690":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":41,"locations":49,"responsibleParty":68,"collaborators":26,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":26,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":51,"whyStopped":26,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Westmead Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Aggressive Hydration","EXPERIMENTAL","Rectal indomethacin 100 mg plus short-stay aggressive hydration: Lactated Ringer's bolus 20 mL\u002Fkg over \\~1 hour, then 3 mL\u002Fkg\u002Fhour for 3 hours (post-procedure infusion capped at 1000 mL).",[13,14],"Other: Short-Stay Aggressive Hydration","Drug: Rectal Indomethacin",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard Care","ACTIVE_COMPARATOR","Rectal indomethacin 100 mg plus standard low-volume hydration at proceduralist\u002Fanaesthetist discretion (Lactated Ringer's up to 1.5 mL\u002Fkg\u002Fhour, max 500 mL over 3 hours).",[20,14],"Other: Standard Peri-procedural Hydration",[22,27,31],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"Short-Stay Aggressive Hydration","Lactated Ringer's bolus 20 mL\u002Fkg over \\~1 hour then 3 mL\u002Fkg\u002Fhour x 3 hours (cap 1000 mL post-procedure); rate capped at BMI 40 if BMI \\> 40.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Peri-procedural Hydration","Low-volume Lactated Ringer's at operator discretion, up to 1.5 mL\u002Fkg\u002Fhour, max 500 mL over 3 hours.",[16],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"DRUG","Rectal Indomethacin","Indomethacin 100 mg per rectum within 30 minutes before, during or after ERCP.",[9,16],[37],{"name":38,"affiliation":39,"role":40},"Nicholas Burgess","Department of Gastroenterology and Hepatology, Westmead Hospital, Sydney, Australia","PRINCIPAL_INVESTIGATOR",[42,46],{"name":38,"role":43,"phone":44,"phoneExt":26,"email":45},"CONTACT","+61288905555","nicholas.burgess@health.nsw.gov.au",{"name":47,"role":43,"phone":26,"phoneExt":26,"email":48},"Brian Lam","briannicholas.lam@mail.utoronto.ca",[50],{"facility":5,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Westmead","New South Wales","2145","Australia","AU",{"type":58,"coordinates":59},"Point",[60,61],150.98768,-33.80383,{"lat":61,"lon":60},[64,66,67],{"name":38,"role":43,"phone":44,"phoneExt":26,"email":65},"nicholas.burgess@health.nsw.go.vau",{"name":47,"role":43,"phone":26,"phoneExt":26,"email":48},{"name":38,"role":40,"phone":26,"phoneExt":26,"email":26},{"type":40,"investigatorFullName":38,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Coordinating Principal Investigator","100652690","short-stay-aggressive-hydration-to-prevent-post-ercp-pancreatitis-100652690",false,"NCT07776561","Short-Stay Aggressive Hydration to Prevent Post-ERCP Pancreatitis","Preventing Post ERCP Pancreatitis by Short Stay Aggressive Hydration (PuSH) -a Prospective Randomized Trial.","PuSH","Inclusion Criteria:\n\n* Age over 18 years\n* Undergoing ERCP\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Unable to give consent\n* Clinical signs\u002Fsymptoms of congestive cardiac failure (pitting oedema, NYHA class ≥ 2, or oxygen saturation ≤ 90%)\n* Respiratory failure (pre-procedure SpO2 \\\u003C 90% on room air, or requirement for non-invasive\u002Fmechanical ventilation)\n* Contraindication to rectal NSAIDs (allergy; active gastrointestinal bleeding)\n* Estimated GFR (MDRD) ≤ 30 mL\u002Fmin\n* Altered biliary or duodenal anatomy (e.g. prior biliary\u002Fpancreatic surgery, Roux-en-Y reconstruction)\n* Known hypo- or hypernatraemia (serum sodium \\\u003C 130 or \\> 150 mmol\u002FL)\n* Pregnancy\n* Severe liver disease (cirrhosis with ascites)\n* Previous sphincterotomy (unless undergoing pancreatic duct intervention)\n* Acute pancreatitis\n* Chronic pancreatitis (unless undergoing a pancreatic duct intervention)\n* Sphincter of Oddi dysfunction\n* Pancreatic mass causing biliary obstruction","ALL","18 Years",{"count":81,"type":82},1300,"ESTIMATED","INTERVENTIONAL",[85],"NA","Post-ERCP pancreatitis (PEP) is the most common serious adverse event after endoscopic retrograde cholangiopancreatography (ERCP), occurring in roughly 7-15% of patients. Rectal non-steroidal anti-inflammatory drugs (NSAIDs) and peri-procedural aggressive intravenous hydration each reduce PEP, but published hydration regimens are delivered over 8-24 hours and require an overnight hospital stay, which is impractical where ERCP is increasingly performed as a same-day procedure.\n\nThis multicentre, prospective, randomised controlled trial tests whether a short (under 4 hours) aggressive hydration regimen with Lactated Ringer's solution, combined with rectal indomethacin, is superior to standard care (rectal indomethacin plus low-volume hydration) for preventing PEP, while supporting same-day discharge. Adults undergoing ERCP are randomised 1:1. The primary outcome is the incidence of PEP defined by consensus (Cotton) criteria. A total of 1300 participants (650 per arm) will be enrolled.",[88,89],"Post-ERCP Pancreatitis","Pancreatitis",[91,92,93,94,95,96,97],"ERCP","Post-ERCP pancreatitis","Aggressive hydration","Lactated Ringer's solution","Rectal indomethacin","Fluid resuscitation","Same-day discharge","2026-08-18",{"date":100,"type":101},"2026-08-20","ACTUAL",{"date":103,"type":101},"2026-06-01",{"date":105,"type":82},"2029-06-01",{"name":5,"class":6},1]