[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07681050":3,"trial-entities:NCT07681050":111,"trial-summary:NCT07681050":115},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":47,"secondary_outcomes":55,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":81,"locations":84,"central_contacts":102,"overall_officials":106,"references":109,"see_also_links":110},"NCT07681050","Pro00120087","Phosphate in Acute Pancreatitis","Phosphate in Acute Pancreatitis (PPP)","RECRUITING","2029-01","2026-07","2026-07-17","2026-07-09","Duke University","OTHER",true,"The goal of this study is to learn if phosphate administration works to treat acute pancreatitis in adults presenting to the emergency department at Duke University Hospital. The main questions it aims to answer are:\n\n* Does having low phosphate levels increase the risk of acute pancreatitis and can giving phosphate through an IV make the illness less severe?\n* Is phosphate therapy practical to use, and what is the appropriate dose?\n* Is this study achievable, and how can the results help design a future randomized controlled trial to assess safety and effectiveness?\n\nParticipants will:\n\n* Receive standard of care or intravenous (IV) phosphate during their hospital stay\n* Have blood samples collected during admission to monitor phosphorus levels\n* Complete follow-up assessments after hospital admission to evaluate how severe the illness is and the effects of phosphate supplementation","This prospective, two-phase pilot clinical trial will enroll 100 adult emergency department patients with acute pancreatitis (50 per phase) at Duke University Hospital.\n\nPhase one will consist of an observational control group receiving usual care, with serum phosphorus collected throughout the emergency department visit and hospitalization to examine how phosphorus levels change over time and relate to disease severity and clinical outcomes.\n\nPhase two will include a treatment group receiving continuous intravenous sodium phosphate or potassium phosphate infusions to maintain high-normal serum phosphorus levels (4.0-4.5 mg\u002FdL) during the first 72 hours of hospitalization. Phosphate dosing requirements will be determined and compared across varying levels of disease severity to assess whether more severe illness is associated with greater supplementation needs.\n\nOverall, the study will characterize phosphorus dynamics in acute pancreatitis, evaluate the feasibility and dosing of phosphate repletion, and generate preliminary data to inform the design of a future randomized controlled trial assessing the safety and efficacy of phosphate therapy.",[19],"Pancreatitis",[21,19,22,23,24,25,26],"Pancreas","Phosphate","Hypophosphatemia","Hyperphosphatemia","Sodium Phosphate","Potassium Phosphate","INTERVENTIONAL","TREATMENT",[30],"PHASE2",{"count":32,"type":33},100,"ESTIMATED",[35,42],{"type":36,"name":25,"description":37,"armGroupLabels":38,"otherNames":40},"DRUG","The treatment is administered via continuous peripheral intravenous infusion at a rate of 30 mmol every 6 hours, provided serum phosphorus levels remain at or below 4.0 mg\u002FdL; it begins upon patient enrollment and continues for up to 72 hours.",[39],"Phosphate Treatment Phase",[41],"Sodium Phosphate Injection, USP, 3mM P\u002FmL",{"type":36,"name":26,"description":43,"armGroupLabels":44,"otherNames":45},"This treatment will be used in case of hypernatremia. The treatment is administered via continuous peripheral intravenous infusion at a rate of 30 mmol every 6 hours, provided serum phosphorus levels remain at or below 4.0 mg\u002FdL; it begins upon patient enrollment and continues for up to 72 hours.",[39],[46],"Potassium Phosphates Injection",[48,52],{"measure":49,"description":50,"timeFrame":51},"Serum Phosphorus Levels","Serum phosphorus levels measured in a control (observational) group of patients with acute pancreatitis. This will be determined utilizing the Revised Atlanta Classification.","During hospitalization, up to approximately 7 days",{"measure":53,"description":54,"timeFrame":51},"Disease Severity as measured by the Revised Atlanta Classification (RAC)","The RAC is categorized into three levels based on the absence or presence of organ failure and local or systemic complications: Mild = No organ failure and no local or systemic complications, Moderately Severe = Transient organ failure (resolving within 48 hours) OR local\u002Fsystemic complications without persistent organ failure, Severe = Persistent organ failure (lasting more than 48 hours) that can involve a single or multiple organ systems.",[56,60,64],{"measure":57,"description":58,"timeFrame":59},"Dosing Requirements","Determine the dosing requirements of phosphate treatment in a treatment group of patients with acute pancreatitis to maintain a high-normal phosphorus level (4.0-4.5 mg\u002FdL) during their emergency department (ED) and hospital stay, with serum phosphorus levels being measured every 6 hours.","During the first 72 hours of hospital admission and phosphate administration",{"measure":61,"description":62,"timeFrame":63},"Feasibility as measured by the proportion of treatment-group participants receiving at least one infusion","Based on the prospective phosphate supplementation phase, determine the feasibility of developing a randomized controlled trial to assess safety and efficacy of phosphate treatment in patients with acute pancreatitis.","Up to 3 months post-discharge",{"measure":65,"description":62,"timeFrame":63},"Feasibility as measured by the proportion of treatment-group participants completing treatment","ALL","18 Years",null,false,{"inclusion":71,"exclusion":76,"raw_text":80},[72,73,74,75],"Age 18 years or older","Presenting to the emergency department (ED) with acute pancreatitis meeting 2 or more characteristics of: (1) typical, persistent, severe upper abdominal pain, (2) lipase or amylase levels at least three times greater than the upper limit of normal, and\u002For (3) characteristic findings on abdominal imaging)","Trial treatment can be initiated within 24 hours of hospital admission","Consent can be obtained from the patient or their legal representative",[77,78,79],"Hyperkalemia","Hypercalcemia or significant hypocalcemia","Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2) or end-stage renal disease","Inclusion Criteria:\n\n* Age 18 years or older\n* Presenting to the emergency department (ED) with acute pancreatitis meeting 2 or more characteristics of: (1) typical, persistent, severe upper abdominal pain, (2) lipase or amylase levels at least three times greater than the upper limit of normal, and\u002For (3) characteristic findings on abdominal imaging)\n* Trial treatment can be initiated within 24 hours of hospital admission\n* Consent can be obtained from the patient or their legal representative\n\nExclusion Criteria:\n\nContraindications to injectable phosphate including:\n\n* Hyperkalemia\n* Hypercalcemia or significant hypocalcemia\n* Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2) or end-stage renal disease",[82,83],"ADULT","OLDER_ADULT",[85],{"facility":86,"status":8,"city":87,"state":88,"zip":89,"country":90,"contacts":91,"geoPoint":99},"Duke University Medical Center","Durham","North Carolina","27710","United States",[92,96],{"name":93,"role":94,"email":95},"Lezly Collins","CONTACT","lezly.collins@duke.edu",{"name":97,"role":98},"Samuel Francis, MD","PRINCIPAL_INVESTIGATOR",{"lat":100,"lon":101},35.99403,-78.89862,[103],{"name":97,"role":94,"phone":104,"email":105},"919-684-5537","samuel.francis@duke.edu",[107],{"name":97,"affiliation":108,"role":98},"Duke University Hospital",[],[],{"nct_id":4,"conditions":112,"biomarkers":114},[113],"Acute Pancreatitis",[],{"nct_id":4,"found":15,"summary":116,"prompt_version":126},{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is a two-phase pilot study involving 100 adult patients with acute pancreatitis. The first phase is observational, and the second phase involves a treatment group.","completed","Phosphate in Acute Pancreatitis Study","This study at Duke University Hospital is looking into whether giving phosphate through an IV can help adults with acute pancreatitis (inflammation of the pancreas). Researchers want to see if low phosphate levels make pancreatitis worse and if giving Sodium Phosphate or Potassium Phosphate can make the illness less severe. They are also trying to figure out the best dose and if this treatment is practical to use. You might be able to join if you are 18 or older and come to the emergency department with acute pancreatitis symptoms, like severe abdominal pain or high lipase\u002Famylase levels. The study will measure your serum phosphorus levels and how severe your disease is to see if the treatment is successful. The current status of the study is unclear.","Your disease severity and serum phosphorus levels will be measured during hospitalization, up to approximately 7 days.",127,"If you are in the treatment group, you would receive continuous intravenous infusions of Sodium Phosphate or Potassium Phosphate for up to 72 hours. Your serum phosphorus levels will be measured during your hospitalization, up to about 7 days.","Not stated in the trial record.",[25,26],"v2"]