[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632793":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":42,"collaborators":46,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":26,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":72,"whyStopped":26,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":26},{"fullName":5,"class":6},"Southeast University, China","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Citrate group","ACTIVE_COMPARATOR","Participants in this arm receive regional citrate anticoagulation during continuous renal replacement therapy (CRRT) according to standard institutional protocols. Citrate is infused pre-filter to maintain post-filter ionized calcium concentration between 0.2-0.4 mmol\u002FL, with a maximum not exceeding 0.6 mmol\u002FL. Calcium is replaced post-filter or systemically to maintain normal systemic ionized calcium (1.0-1.2 mmol\u002FL). Anticoagulation targets and dose adjustments follow predefined operational guidelines. Citrate accumulation is monitored by total-to-ionized calcium ratio, and protocol modifications are applied for patients with liver dysfunction or metabolic complications.",[13],"Drug: Citrate anticoagulation",{"label":15,"type":16,"description":17,"interventionNames":18},"NM group","EXPERIMENTAL","Nafamostat mesylate is administered as a continuous pre-filter infusion at an initial dose of 50 mg\u002Fh, adjusted to maintain activated partial thromboplastin time (aPTT) or other regional anticoagulation parameters as specified in the protocol. Dose modifications are made based on filter lifespan and bleeding risk.",[19],"Drug: Nafamostat Mesylate",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Citrate anticoagulation","Citrate (3% or 4% trisodium citrate solution) is a regional anticoagulant that chelates ionized calcium in the extracorporeal circuit, thereby inhibiting the coagulation cascade. The control product is supplied as an injection solution. It should be stored in a tightly closed container. During CRRT, citrate is infused pre-filter (before the blood pump) and requires separate systemic calcium replacement to maintain normal ionized calcium levels.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Nafamostat Mesylate","Nafamostat mesylate is a synthetic serine protease inhibitor with a very short half-life (approximately 8 minutes). It acts locally as an anticoagulant by inhibiting thrombin, factor Xa, and other coagulation proteases. The investigational product is supplied as a lyophilized powder for injection. It must be protected from light and stored below 25 °C. For use during continuous renal replacement therapy (CRRT), the powder is reconstituted and administered as a continuous pre-filter infusion.",[15],[32],{"name":33,"affiliation":34,"role":35},"Yingzi Huang","Zhongda Hospital","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Xiwen Zhang","CONTACT","+86 025-83262750","xiwen_zhang@126.com",{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Jianfeng Xie","Prof.",[47],{"name":5,"class":6},"100632793","phase-4-nafamostat-mesylate-versus-regional-citrate-anticoagulation-for-continuous-renal-replacement-therapy-in-sepsis-associated-acute-kidney-injury-100632793",false,"NCT07518303","Nafamostat Mesylate Versus Regional Citrate Anticoagulation for Continuous Renal Replacement Therapy in Sepsis-Associated Acute Kidney Injury","NICE-AKI","Inclusion Criteria:\n\n* Age 18 to 90 years, inclusive, regardless of sex.\n* Meets Sepsis 3.0 diagnostic criteria and develops acute kidney injury within 7 days after the diagnosis of sepsis.\n* After adequate resuscitation, meets KDIGO 2012 stage 2 or stage 3 acute kidney injury criteria, including any of the following:\n\nSerum creatinine increased to more than 3 times baseline; or Serum creatinine ≥4.0 mg\u002FdL \\[353.6 μmol\u002FL\\]; or Urine output \\\u003C0.3 mL\u002Fkg\u002Fh for ≥24 hours; or Anuria, defined as extremely low or absent urine output, lasting ≥12 hours.\n\nOr has an indication for CRRT, including any of the following:\n\nBlood urea nitrogen \\>150 mg\u002FdL; or Serum potassium \\>6 mmol\u002FL; or pH \\\u003C7.15; or Organ edema and\u002For fluid overload in the setting of AKI that is refractory to diuretic therapy.\n\n* Expected duration of CRRT treatment \\>48 hours.\n* Written informed consent obtained.\n\nExclusion Criteria:\n\n* Requirement for therapeutic anticoagulation, such as pulmonary embolism or deep vein thrombosis.\n* Contraindication to systemic anticoagulation.\n* Hemolytic uremic syndrome or thrombotic thrombocytopenic purpura.\n* Acute liver failure and\u002For shock with persistent severe lactic acidosis, defined as two consecutive measurements of pH \\\u003C7.2 lasting for more than 2 hours, with lactate \\>72.1 mg\u002FdL \\[8 mmol\u002FL\\].\n* Chronic kidney disease requiring long-term regular dialysis.\n* Acute kidney injury caused by permanent bilateral renal artery occlusion or surgical injury.\n* Acute kidney injury caused by glomerulonephritis, interstitial nephritis, or vasculitis.\n* Known allergy to study drugs, including nafamostat mesylate, sodium citrate, or their excipients.\n* Kidney transplantation within 1 year.\n* Planning pregnancy in the near term, pregnancy, or lactation.\n* HIV infection.\n* Only adsorptive filters such as oXiris are available at study enrollment.\n* Participation in another clinical trial within the previous 3 months.\n* Judged by the investigator to be in a moribund state or unlikely to complete the study intervention and primary outcome assessment, including but not limited to expected death within 24 hours after enrollment, decision for do-not-resuscitate order or limitation\u002Fwithdrawal of life-sustaining treatment, or planned abandonment of active treatment and self-discharge within 24 hours due to terminal disease or patient\u002Ffamily preference.\n* Any other condition that, in the investigator's judgment, makes the patient unsuitable for enrollment.","ALL","18 Years","90 Years",{"count":59,"type":60},1162,"ESTIMATED","INTERVENTIONAL",[63],"PHASE4","This multicenter, randomized, open-label, active-controlled, parallel-group trial will evaluate the efficacy and safety of nafamostat mesylate anticoagulation compared with regional citrate anticoagulation in adult patients with sepsis-associated acute kidney injury requiring continuous renal replacement therapy. Eligible participants will be randomized in a 1:1 ratio to receive either nafamostat mesylate or regional citrate anticoagulation during CRRT. The primary outcome is MAKE30, a composite of all-cause mortality, new or ongoing renal replacement therapy, or persistent renal dysfunction within 30 days after randomization. Secondary outcomes include filter lifespan, CRRT-free days, 30-day all-cause mortality, renal replacement therapy status, persistent renal dysfunction, ICU and hospital mortality, length of stay, CRRT duration, major bleeding, new bloodstream infection during ICU stay, SOFA score, number of filters used, and protocol-defined safety outcomes.",[66,67,68],"Sepsis","Acute Kidney Injury","Continuous Renal Replacement Therapy (CRRT)",[28,68,66,70,71],"Acute Kidney Injury (AKI)","Randomized Clinical Trial (RCT)","NOT_YET_RECRUITING","2026-06-01",{"date":75,"type":76},"2026-06-03","ACTUAL",{"date":78,"type":60},"2026-06-10",{"date":80,"type":60},"2028-12-10",{"name":44,"class":6}]