Comparison of Nafamostat and Unfractionated Heparin in RRT for Sepsis Associated AKI

Summary

The goal of this clinical trial is to compare the safety and efficacy of nafamostat mesylate (NM) and unfractionated heparin (UFH) in the process of renal replacement therapy (RRT) for patients suffering from sepsis associated acute kidney injury (SA-AKI). The main questions it aims to answer are: The impact of NM and UFH on platelet count in septic patients undergoing RRT treatment. The satisfaction with anticoagulation of NM and UFH in septic patients undergoing RRT treatment. The 28-day all-cause mortality rate of septic patients undergoing RRT treatment with NM and UFH. Researchers will use NM or UFH as anticoagulation during RRT in SA-AKI patients, assessing effects on platelet count, anticoagulation satisfaction, and mortality. Participants will receive NM or UFH as anticoagulation during RRT for a minimum of 7 days. Bleeding symptoms, platelet count and coagulation function will be monitored daily. Platelet changes during the 7-day treatment period and survival status at 28 days post-treatment will be recorded.

Timeline

Start

2024-04

Primary completion

2027-04

Completion

2027-04

Publications

• Background Zarbock A, Nadim MK, Pickkers P, Gomez H, Bell S, Joannidis M, Kashani K, Koyner JL, Pannu N, Meersch M, Reis T, Rimmele T, Bagshaw SM, Bellomo R, Cantaluppi V, Deep A, De Rosa S, Perez-Fernandez X, Husain-Syed F, Kane-Gill SL, Kelly Y, Mehta RL, Murray PT, Ostermann M, Prowle J, Ricci Z, See EJ, Schneider A, Soranno DE, Tolwani A, Villa G, Ronco C, Forni LG. Sepsis-associated acute kidney injury: consensus report of the 28th Acute Disease Quality Initiative workgroup. Nat Rev Nephrol. 2023 Jun;19(6):401-417. doi: 10.1038/s41581-023-00683-3. Epub 2023 Feb 23.
• Background Poston JT, Koyner JL. Sepsis associated acute kidney injury. BMJ. 2019 Jan 9;364:k4891. doi: 10.1136/bmj.k4891.
• Background Ohtake Y, Hirasawa H, Sugai T, Oda S, Shiga H, Matsuda K, Kitamura N. Nafamostat mesylate as anticoagulant in continuous hemofiltration and continuous hemodiafiltration. Contrib Nephrol. 1991;93:215-7. doi: 10.1159/000420222. No abstract available.
• Background Uchino S, Bellomo R, Morimatsu H, Morgera S, Schetz M, Tan I, Bouman C, Macedo E, Gibney N, Tolwani A, Oudemans-van Straaten H, Ronco C, Kellum JA. Continuous renal replacement therapy: a worldwide practice survey. The beginning and ending supportive therapy for the kidney (B.E.S.T. kidney) investigators. Intensive Care Med. 2007 Sep;33(9):1563-70. doi: 10.1007/s00134-007-0754-4. Epub 2007 Jun 27.
• Background Maruyama Y, Yoshida H, Uchino S, Yokoyama K, Yamamoto H, Takinami M, Hosoya T. Nafamostat mesilate as an anticoagulant during continuous veno-venous hemodialysis: a three-year retrospective cohort study. Int J Artif Organs. 2011 Jul;34(7):571-6. doi: 10.5301/IJAO.2011.8535.
• Background Makino S, Egi M, Kita H, Miyatake Y, Kubota K, Mizobuchi S. Comparison of nafamostat mesilate and unfractionated heparin as anticoagulants during continuous renal replacement therapy. Int J Artif Organs. 2016 Jan;39(1):16-21. doi: 10.5301/ijao.5000465. Epub 2016 Feb 9.

Drugs

Indications