Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients

End Stage Renal Disease Clinical Trial

— BICATH  

Official title:

Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04054128
• Other study ID #: 479/01/19
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 11, 2019
• Est. completion date: September 28, 2020

Study information

• Verified date: April 2020
• Source: Hospital General “Dr. Miguel Silva” de Morelia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

A prospective, randomized, clinical, open-label trial at Hospital General "Dr. Miguel Silva" de Morelia, Mexico.

The study period will be between august 16, 2019 to November 16, 2019. The aim of this study is to evaluate the efficacy of catheter lock with bicarbonate vs heparin in chronic hemodialysis patients. Primary outcome will be catheter function. Secondary outcomes will be Infectious complications, thrombotic complications, and frequency of adverse effects between groups.

All patients provided written informed consent before enrollment. The trial protocol was approved by Hospital General "Dr. Miguel Silva" Internal Review Board, register number 17-CI-16053153, and Research & Ethics committee, with register number 16-CEI-004-20161212, Study registry # 479/01/9.

Patients between 18-65 years old, incident or prevalent chronic hemodialysis, with 1 month of clinical stability and with temporal catheter as vascular access for hemodialysis are eligible. A total of 60 patients will be included in the study. All patients will be randomly assigned into one of two groups: SBCL (n=30), intervention group and HCL (n=30), as control group.

Before each hemodialysis treatment, catheters and connections will be inspected for leaks, evidence of damage, exit-site infection and tunnel infection. Intraluminal SBCL or HCL solution will be removed before connecting the hemodialysis catheter to a dialysis machine prior to any treatment.

During each treatment, patients will be prescribed and monitored for complications and standard treatment will be provided to every patient. After each treatment, blood will be rinsed from dialysis lines with 0.9% saline solution back to the patient. Upon the conclusion of treatment, all catheters will be flushed with 10 mL 0.9% saline solution per blood line respectively, after saline flush, catheter lock will be prescribed; SBCL group with 7.5% sodium bicarbonate solution, at a dose of 2 milliliters per lumen, and HCL group with sodium heparin at a concentration of 1000 units per milliliter, at a dose of 2 milliliters per lumen. Catheter exit site dressing changes occurred after each HD treatment.

Niagra 13.5 French/20 cm non tunneled catheter will be the standard vascular access. All central venous catheters will be inserted by an expert operator under strict aseptic protocol. Catheter care will be performed by trained dialysis staff. At the end of dialysis, all catheters will be flushed and locked with the respectively arm solution.

Function assessment will be based on both, pressure and flow measurements on arterial line, as well as measurements of arterial and venous line pressures and flow during hemodialysis sessions. Infectious and thrombotic complications will be assessed as defined.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 28, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients who accept participation and sign informed consent.

• Incident or prevalent chronic hemodialysis patients who receive at least 2 sessions per week with 1 month of clinical stability defined as: no hospitalizations, no vascular access infections, no changes in blood flow prescription due to vascular access dysfunction.

• Patients with temporal catheter (Niagra 13.5 French/20 cm length, BARD Access System, Salt Lake City, Utah, USA) as vascular access for hemodialysis.

Exclusion Criteria:

• Catheter dysfunction at baseline

• On anticoagulation therapy

• Patients with known coagulopathy or hemophilia

• Patients with Child-Pugh B or C liver failure

• Patients with thrombocytopenia less than 100,000 u / L

• Patients with central vessel stenosis and vena cava syndrome, previously documented.

• Patients with vascular access exhaustion.

• Patients who have undergone more than 2 vascular approaches for hemodialysis catheters.

• Patients with heparin-induced thrombocytopenia

Related Conditions & MeSH terms

• Catheter Complications
• End Stage Renal Disease
• Hemodialysis Access Failure
• Hemodialysis Catheter Infection
• Kidney Failure, Chronic
• Vascular Access Complication

Intervention

Drug:
• Sodium Bicarbonate 7.5% Injection
Sodium bicarbonate solution for catheter lock; 7.5% sodium bicarbonate solution will be used for catheter lock in both catheter lumens, 1.9 mL in each catheter lumen will be infused after hemodialysis treatment during 3 months.
• Heparin Sodium, 1000 Units/mL Injectable Solution 1
Heparin for catheter lock: 1000 u/mL heparin solution will be used for catheter lock in both catheter lumens as standard treatment, 1.9 mL in each catheter lumen will be infused after hemodialysis treatment during 3 months.

Locations

Country	Name	City	State
Mexico	Hospital General "Dr. Miguel Silva" de Morelia	Morelia	Michoacan

Sponsors (3)

Lead Sponsor	Collaborator
Hospital General “Dr. Miguel Silva” de Morelia	NAUSLIFE HEMODIALYSIS CLINICS, Universidad Nacional Autonoma de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (15)

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. — View Citation

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. Epub 2005 Apr 26. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. Erratum in: Lancet. 2013 Jul 20;382(9888):208. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Palomo I, Pereira J, Alarcón M, Díaz 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. — View Citation

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. Epub 2006 Apr 20. — View Citation

Wong DW, Mishkin FS, Tanaka TT. The effects of bicarbonate on blood coagulation. JAMA. 1980 Jul 4;244(1):61-2. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients	Arterial line pressure[mmHg] at 300 mL/min blood flow will be compared between sodium bicarbonate lock and heparin lock in chronic hemodialysis patients.	30 days.
Primary	Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients	Arterial line pressure[mmHg] at 300 mL/min blood flow will be compared between sodium bicarbonate lock and heparin lock in chronic hemodialysis patients.	60 days
Primary	Arterial line pressure at fixed blood flow in sodium bicarbonate lock versus heparin lock catheters in chronic hemodialysis patients	Arterial line pressure[mmHg] at 300 mL/min blood flow will be compared between sodium bicarbonate lock and heparin lock in chronic hemodialysis patients.	90 days
Secondary	Incidence rate of catheter related bloodstream infection	Catheter related bloodstream infection rate (events per 100 days/catheter) will be compare between sodium bicarbonate lock versus heparin lock in chronic hemodialysis patients	90 days
Secondary	Incidence rate of catheter thrombosis	Catheter thrombosis rate (events per 100 days/catheter) will be compare between sodium bicarbonate lock versus heparin lock in chronic hemodialysis patients	90 days
Secondary	Adverse events incidence	To compare the frequency of hemorrhagic event, anaphylaxis, hypernatremia or death between sodium bicarbonate lock vs heparin lock in chronic hemodialysis patients	90 days