Acute Kidney Injury
Conditions
Interventions
Regional Citrate Anticoagulant:During continuous kidney replacement therapy (CKRT), citrate is used for anticoagulation.
Nafamostat Mesylate Anticoagulant:During continuous kidney replacement therapy (CKRT), nafamostat mesylate is used for anticoagulation.
Regional Citrate + Nafamostat Mesylate Anticoagulant:During continuous kidney replacement therapy (CKRT), citrate combined nafamostat mesylate are used for anticoagulation.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Indication for CKRT (meeting KDIGO AKI Stage 2-3 (Stage 2 AKI: 2.0-2.9 fold increase of Scr from baseline or urine output =12 hours ; Stage 3 AKI: urine output 24h and/or 3-fold increase of Scr from baseline or Scr> 4mg/dl with acute increase of > 0.5 mg/dl), pH 6.0 mmol/L, or diuretic-resistant fluid overload and so on); 2. 18-90 years old, regardless of gender; 3. Patients meeting the Sepsis-3 diagnostic criteria; 4. Anticipated ICU stay >72 hours, and projected CRRT treatment duration >48 hours; 5. Written informed consent. * CKRT, continuous kidney replacement therapy; Scr, serum creatinine; AKI, acute kidney injury; APTT, activated partial thromboplastin time; K+, potassium; CRP, C-reactive protein; PCT, procalcitonin; IL-6, Interleukin-6; WBC, white blood cell; *Sepsis-3 diagnostic criteria: 1) confirmed or suspected infection; and 2) an increase in the Sequential Organ Failure Assessment (SOFA) score by >= 2 points from baseline.
Exclusion criteria
Exclusion criteria: 1. Contraindications to either RCA or NM use (e.g., severe hepatic insufficiency, lactate >4 mmol/L, or allergy to either anticoagulant) 2. ESKD patient with previous dialysis dependence 3. Severe coagulopathy: Plt 2.5, or APTT >60 seconds 4. Active bleeding 5. Concurrent use of another anticoagulant 6. Pregnancy or lactation 7. History of solid organ transplantation within the past 12 months, or scheduled for transplantation within the next 3 months 8. Uncorrectable critical organ dysfunction prior to enrollment: Refractory hypotension (systolic blood pressure 2 hours despite vasopressor support), or Severe hypoxemia (PaO2 <60 mmHg), or Hypercalcemia 9. Concurrent use of other extracorporeal blood purification therapies during the study period (e.g., endotoxin/cytokine adsorption, hemoperfusion, plasma exchange, or extracorporeal membrane oxygenation 10. AKI primarily attributed to specific renal pathologies such as bilateral renal artery stenosis/occlusion, acute interstitial nephritis, urinary tract obstruction, or acute glomerulonephritis 11. Participation in another interventional clinical trial within the past 3 months 12. Any other condition that, in the opinion of the investigator, poses an unacceptable risk to the patient or could confound the trial results. * RCA, regional citrate anticoagulation; NM, nafamostat mesylate; ESKD, end-stage kidney disease; Plt, platelet; INR, international normalized ratio.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Extracorporeal Circuit Lifespan; | — |
Secondary
| Measure | Time frame |
|---|---|
| 72-hour Extracorporeal Circuit survival rate;ICU mortality;in-hospital mortality;28-day mortality;90-day mortality;ICU length of stay;hospital length of stay;28-day dialysis liberation rate;Total duration of CKRT therapy;Levels of inflammatory biomarkers (e.g., CRP, PCT) within 72 hours after initiation of CKRT;the patient's SOFA score at 72 hours after the initiation of CKRT;Thrombotic events newly occurring in the patient, encompassing the entire duration from the initiation to the discontinuation of this CKRT circuit.;24-hour Extracorporeal Circuit survival rate;48-hour Extracorporeal Circuit survival rate; | — |
Countries
China
Contacts
Public ContactLing Zhang
West China Hospital of Sichuan University
Outcome results
None listed