drugset / Trial / NCT04054128
Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients
Phase 4
Unknown
60 enrolled
Hospital General "Dr. Miguel Silva" de Morelia
NAUSLIFE HEMODIALYSIS CLINICS · collabUniversidad Nacional Autonoma de Mexico · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
Prospective clinical trial to evaluate the efficacy of catheter lock with bicarbonate vs heparin in chronic hemodialysis patients. Two groups will be created, sodium bicarbonate lock group (experimental group) and heparin lock group (control group). Catheter pressures, flow, patency and infection outcomes will be compare between groups at different time points (30, 60 and 90 days).
Timeline
- Start
- 2019-09-11
- Primary completion
- 2020-02-20
- Completion
- 2020-09-28
Publications
- Background Jha V, Garcia-Garcia G, Iseki K, Li Z, Naicker S, Plattner B, Saran R, Wang AY, Yang CW. Chronic kidney disease: global dimension and perspectives. Lancet. 2013 Jul 20;382(9888):260-72. doi: 10.1016/S0140-6736(13)60687-X. Epub 2013 May 31.
- Background Ma A, Shroff R, Hothi D, Lopez MM, Veligratli F, Calder F, Rees L. A comparison of arteriovenous fistulas and central venous lines for long-term chronic haemodialysis. Pediatr Nephrol. 2013 Feb;28(2):321-6. doi: 10.1007/s00467-012-2318-2. Epub 2012 Oct 6.
- Background Adib-Hajbaghery M, Molavizadeh N, Alavi NM. Quality of care of vascular access in hemodialysis patients in a hemodialysis center in Iran. J Vasc Nurs. 2012 Mar;30(1):24-8. doi: 10.1016/j.jvn.2011.10.002.
- Background Agharazii M, Plamondon I, Lebel M, Douville P, Desmeules S. Estimation of heparin leak into the systemic circulation after central venous catheter heparin lock. Nephrol Dial Transplant. 2005 Jun;20(6):1238-40. doi: 10.1093/ndt/gfh841. Epub 2005 Apr 26.
- Background Moran JE, Ash SR; ASDIN Clinical Practice Committee. Locking solutions for hemodialysis catheters; heparin and citrate--a position paper by ASDIN. Semin Dial. 2008 Sep-Oct;21(5):490-2. doi: 10.1111/j.1525-139X.2008.00466.x. Epub 2008 Aug 29.
- Background Chen FK, Li JJ, Song Y, Zhang YY, Chen P, Zhao CZ, Gong HY, Yao DF. Concentrated sodium chloride catheter lock solution--a new effective alternative method for hemodialysis patients with high bleeding risk. Ren Fail. 2014 Feb;36(1):17-22. doi: 10.3109/0886022X.2013.830207. Epub 2013 Sep 2.
- Background Palomo I, Pereira J, Alarcon M, Diaz G, Hidalgo P, Pizarro I, Jara E, Rojas P, Quiroga G, Moore-Carrasco R. Prevalence of heparin-induced antibodies in patients with chronic renal failure undergoing hemodialysis. J Clin Lab Anal. 2005;19(5):189-95. doi: 10.1002/jcla.20076.
- Background Yon CK, Low CL. Sodium citrate 4% versus heparin as a lock solution in hemodialysis patients with central venous catheters. Am J Health Syst Pharm. 2013 Jan 15;70(2):131-6. doi: 10.2146/ajhp120300.
- Background Shanks RM, Sargent JL, Martinez RM, Graber ML, O'Toole GA. Catheter lock solutions influence staphylococcal biofilm formation on abiotic surfaces. Nephrol Dial Transplant. 2006 Aug;21(8):2247-55. doi: 10.1093/ndt/gfl170. Epub 2006 Apr 20.
- Background Zhao Y, Li Z, Zhang L, Yang J, Yang Y, Tang Y, Fu P. Citrate versus heparin lock for hemodialysis catheters: a systematic review and meta-analysis of randomized controlled trials. Am J Kidney Dis. 2014 Mar;63(3):479-90. doi: 10.1053/j.ajkd.2013.08.016. Epub 2013 Oct 11.
- Background Beigi AA, HadiZadeh MS, Salimi F, Ghaheri H. Heparin compared with normal saline to maintain patency of permanent double lumen hemodialysis catheters: A randomized controlled trial. Adv Biomed Res. 2014 May 28;3:121. doi: 10.4103/2277-9175.133192. eCollection 2014.
- Background Zhong L, Wang HL, Xu B, Yuan Y, Wang X, Zhang YY, Ji L, Pan ZM, Hu ZS. Normal saline versus heparin for patency of central venous catheters in adult patients - a systematic review and meta-analysis. Crit Care. 2017 Jan 8;21(1):5. doi: 10.1186/s13054-016-1585-x.
- Background Wong DW, Mishkin FS, Tanaka TT. The effects of bicarbonate on blood coagulation. JAMA. 1980 Jul 4;244(1):61-2.
- Background Farha MA, French S, Stokes JM, Brown ED. Bicarbonate Alters Bacterial Susceptibility to Antibiotics by Targeting the Proton Motive Force. ACS Infect Dis. 2018 Mar 9;4(3):382-390. doi: 10.1021/acsinfecdis.7b00194. Epub 2018 Jan 4.
- Background Nostro A, Cellini L, Di Giulio M, D'Arrigo M, Marino A, Blanco AR, Favaloro A, Cutroneo G, Bisignano G. Effect of alkaline pH on staphylococcal biofilm formation. APMIS. 2012 Sep;120(9):733-42. doi: 10.1111/j.1600-0463.2012.02900.x. Epub 2012 Apr 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Heparin | Other / unclassified | 1.9 ml | Other |
| Subject | sodium bicarbonate | Diagnostic / imaging agent | 1.9 ml | Other |