The Efficacy and Safety of Guilu Erxian Jiao in the Treatment of Intradialytic Hypotension

Summary

The goal of this clinical trial is to learn if Guilu Erxian Jiao, a traditional Chinese herbal medicine, can help manage intradialytic hypotension (IDH), a drop in blood pressure that occurs during hemodialysis in adults. The main questions it aims to answer are: 1. Does Guilu Erxian Jiao reduce the frequency and severity of low blood pressure during dialysis? 2. Is Guilu Erxian Jiao safe to use in patients receiving hemodialysis? Researchers will compare standard care plus Guilu ErXian Jiao to standard care alone to see if Guilu Erxian Jiao improves blood pressure stability during dialysis. Participants will: 1. Take Guilu Erxian Jiao once daily in addition to standard care, or receive standard care alone, for 4 weeks, then switch treatments after a 4-week washout period (crossover design). 2. Undergo follow-up assessments at weeks 2 and 4 after each treatment phase. 3. Have their blood pressure monitored before, during (hourly), and after each dialysis session. 4. Report dialysis-related symptoms such as dizziness and fatigue. 5. Receive routine laboratory tests and safety monitoring throughout the study.

Timeline

Start

2025-06-01

Primary completion

2027-05-31

Completion

2028-05-31

Publications

• Background Brunelli SM, Cohen DE, Marlowe G, Van Wyck D. The Impact of Midodrine on Outcomes in Patients with Intradialytic Hypotension. Am J Nephrol. 2018;48(5):381-388. doi: 10.1159/000494806. Epub 2018 Nov 13.
• Background Jindal K, Chan CT, Deziel C, Hirsch D, Soroka SD, Tonelli M, Culleton BF; Canadian Society of Nephrology Committee for Clinical Practice Guidelines. Hemodialysis clinical practice guidelines for the Canadian Society of Nephrology. J Am Soc Nephrol. 2006 Mar;17(3 Suppl 1):S1-27. doi: 10.1681/ASN.2005121372. No abstract available.
• Background Flythe JE, Xue H, Lynch KE, Curhan GC, Brunelli SM. Association of mortality risk with various definitions of intradialytic hypotension. J Am Soc Nephrol. 2015 Mar;26(3):724-34. doi: 10.1681/ASN.2014020222. Epub 2014 Sep 30.
• Background Morfin JA, Fluck RJ, Weinhandl ED, Kansal S, McCullough PA, Komenda P. Intensive Hemodialysis and Treatment Complications and Tolerability. Am J Kidney Dis. 2016 Nov;68(5S1):S43-S50. doi: 10.1053/j.ajkd.2016.05.021.
• Background Flythe JE, Inrig JK, Shafi T, Chang TI, Cape K, Dinesh K, Kunaparaju S, Brunelli SM. Association of intradialytic blood pressure variability with increased all-cause and cardiovascular mortality in patients treated with long-term hemodialysis. Am J Kidney Dis. 2013 Jun;61(6):966-74. doi: 10.1053/j.ajkd.2012.12.023. Epub 2013 Mar 6.
• Background Tattersall J, Martin-Malo A, Pedrini L, Basci A, Canaud B, Fouque D, Haage P, Konner K, Kooman J, Pizzarelli F, Tordoir J, Vennegoor M, Wanner C, ter Wee P, Vanholder R. EBPG guideline on dialysis strategies. Nephrol Dial Transplant. 2007 May;22 Suppl 2:ii5-21. doi: 10.1093/ndt/gfm022. No abstract available.
• Background Mo Y, Liu X, Qin X, Huang J, He Z, Lin J, Hu Q, Cai Y, Liu Z, Wang L. Shenfu injection for intradialytic hypotension: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2014;2014:279853. doi: 10.1155/2014/279853. Epub 2014 Dec 22.
• Background Sands JJ, Usvyat LA, Sullivan T, Segal JH, Zabetakis P, Kotanko P, Maddux FW, Diaz-Buxo JA. Intradialytic hypotension: frequency, sources of variation and correlation with clinical outcome. Hemodial Int. 2014 Apr;18(2):415-22. doi: 10.1111/hdi.12138. Epub 2014 Jan 27.
• Background Kooman J, Basci A, Pizzarelli F, Canaud B, Haage P, Fouque D, Konner K, Martin-Malo A, Pedrini L, Tattersall J, Tordoir J, Vennegoor M, Wanner C, ter Wee P, Vanholder R. EBPG guideline on haemodynamic instability. Nephrol Dial Transplant. 2007 May;22 Suppl 2:ii22-44. doi: 10.1093/ndt/gfm019. No abstract available.

Drugs

Indications