Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients

NCT04054128 | Unknown Phase 4 DMC

• 1 other identifier: 479/01/19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

End Stage Renal Disease; Vascular Access Complication; Catheter Complications; Hemodialysis Access Failure; Hemodialysis Catheter Infection

Keywords

Sodium bicarbonate lock; Heparin lock; Vascular access complication

Outcome Measures

Primary Outcomes (3)

• 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.

• 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

• 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 Outcomes (3)

• Incidence rate of catheter related bloodstream infection

  90 days

• Incidence rate of catheter thrombosis

  90 days

• Adverse events incidence

  90 days

Study Arms (2)

Sodium bicarbonate catheter lock group (SBCL)

EXPERIMENTAL

Chronic hemodialysis patients with a catheter as a vascular access, will be lock with sodium bicarbonate 7.5% Injection.

Drug: Sodium Bicarbonate 7.5% Injection

Heparin catheter lock group (HCL)

ACTIVE COMPARATOR

Chronic hemodialysis patients with a catheter as a vascular access, will be lock with heparin, 1000 Units/mL injectable solution

Drug: Heparin Sodium, 1000 Units/mL Injectable Solution 1

Interventions

Sodium Bicarbonate 7.5% Injection DRUG

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.

Also known as: Bicarnat® arm

Sodium bicarbonate catheter lock group (SBCL)

Heparin Sodium, 1000 Units/mL Injectable Solution 1 DRUG

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.

Also known as: Inhepar® arm

Heparin catheter lock group (HCL)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital General "Dr. Miguel Silva" de Morelia: lead
• Universidad Nacional Autonoma de Mexico: collaborator
• NAUSLIFE HEMODIALYSIS CLINICS: collaborator

Study Sites (1)

Hospital General "Dr. Miguel Silva" de Morelia

Morelia, Michoacán, 58020, Mexico

Location

Related Publications (15)

• 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.

  PMID: 23727169 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.

  PMID: 23052655 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.

  PMID: 22321404 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.

  PMID: 15855206 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.

  PMID: 18764795 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.

  PMID: 23992231 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.

  PMID: 16170812 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.

  PMID: 23292266 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.

  PMID: 16627606 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.

  PMID: 24125729 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.

  PMID: 24949292 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.

  PMID: 28063456 BACKGROUND

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

  PMID: 7382058 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.

  PMID: 29264917 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.

  PMID: 22882263 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Sodium Bicarbonate; Injections; Heparin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Israel Campos, M.D.

  Hospital General "Dr. Miguel Silva" de Morelia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrology fellow

Model Details: Prospective, open label, clinical trial in chronic hemodialysis patients with a catheter as a vascular access, randomized to bicarbonate lock or heparin lock (control) as standard treatment.

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: August 13, 2019
• Study Start: September 11, 2019
• Primary Completion: February 20, 2020
• Study Completion: September 28, 2020
• Last Updated: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)