A Short Term Comparison between two types of Hemodialysis Catheters - Non Tunneled Jugular and Tunneled Jugular
- Conditions
- End stage renal disease,
- Registration Number
- CTRI/2021/04/032680
- Lead Sponsor
- Dr RML Hospital and ABVIMS
- Brief Summary
Haemodialysis continues to be the RenalReplacement therapy of choice in End Stage Renal Disease Patients. Vascularaccess is an integral and important aspect for ESRD patients being started onChronic Haemodialysis treatments. Preliminary data from the Dialysis Outcomesand Practice patterns showed that 14 % of patients in Europe and 34 % ofpatients in the United States start dialysis with an Acute Dialysis Catheter.The prevalence of Acute Catheters in Chronic HD patients is 4 and 15 %respectively in Europe and the United States. Patients referred late forDialysis are more likely to begin Dialysis using an Acute Dialysis Catheter.(1)Despite thecontinuous improvement of dialysis technology and pharmacological treatment,mortality rates for dialysis patients are still high. Cardiovascular death andinfections remain the leading cause of mortality in Dialysis populations.(2,3)
There is inadequate evidence for the KDOQI tomake any recommendations on incident vascular access. The evidence for theassociations between mortality and all cause hospitalizations and incidentvascular access is also inadequate. KDOQI considers it reasonable to use tunnelled central venous catheter(CVC) in preference to non-tunnelled CVC due to the lower infection risk withtunnelled CVC.(4) These statements while valid however presenta problem in real time management in low income countries where patients areoften unable to afford the necessary costs required for inserting a tunnelledcentral venous catheter. In a study done in Nigeria that prospectively followedthe outcomes of Internal Jugular Vein Catheterization with both tunnelled andnon-tunnelled catheters, a non-tunnelled catheter could be used for a durationof 1-8 weeks with catheter related bacteraemia being the limiting factor forremoval.(5)Another Study done in Canada prospectivelyfollowed patients with un-cuffed Internal Jugular Catheters inserted fordialysis purpose and reported only 5.4 % incidence in bacteraemia after 3 weeksof usage.(6) This was against the KDOQI guideline at thetime which recommended catheter usage for 21 days at the Internal Jugular Site.Current KDOQI guidelines recommend CVC usage at the Internal Jugular site forless than 2 weeks. This recommendation however is largely based on expertopinions and there are no large prospective studies done to study risk ofbacteraemia and catheter removal rates in the haemodialysis population.
Morethan 65% of patients of chronic kidney disease (CKD)present as end-stage renaldisease (ESRD) to nephrologists inIndia.(7) Hence it is difficult for any systematicplanning in ESRD patients to be done for a Permanent Vascular Access. Majorityof patients often start dialysis on an emergency basis either with Jugular orFemoral un-cuffed catheters with a permanent vascular access planned laterafter stabilization of their clinical status. As such a number of Patients inthe low-income group are unable to afford placement and care of Tunnelled JugularCatheters which come at a much higher price than non-tunnelled Catheters. Withthe market cost of Tunnelled Jugular Catheters ranging from 7000 to 32,000Rupees, along with the cost of medication and investigations the financialburden on a CKD 5D patient from a lower income group is substantial. NonTunnelled Jugular catheters on the other hand are relatively cheaper within theprice range of 1200 – 1800 Rupees placing less of a financial burden on poorpatients. Therelative risk of(1) TVC’s causing bacteraemia in patients isapproximately ten times higher than the risk of bacteraemiain patients with AVfistula. (7)The risk of infection-relatedhospitalization/mortality is 2–3 fold higher with TVC’s incomparison to AV Fistula.(8)The cumulative risk of CRBSI was 35% at 3months and 48% at 6 months in one study.(9)Studies have also shown that Non TunnelledHemodialysis Catheters have a 5 fold greater risk of infection than Tunnelled HemodialysisCatheters.(10,11) Considering the high risks of CRBSI alongwith the cost for Tunnelled IJV Catheters, it is imperative to have a lowercost solution as dialysis access for this population group which providesadequate dialysis for Patients till the time an AVF is constructed and matures.
ThisStudy Aims to compare Catheter related Outcomes between Tunnelled and NonTunnelled IJV Catheters in terms of Catheter Removal Rates and AVFconstruction. The Aim being to prove that Non Tunnelled Jugular Catheters canbe a low cost stable vascular access for more than2 weeks for a patientawaiting AVF construction and maturation and become a viable option for lowincome group patients in India who cannot afford Tunnelled Jugular Cathetersfor Dialysis.
REFERENCES
1. Arora P, Obrador GT, RuthazerR, Kausz AT, Meyer KB, Jenuleson CS, et al. Prevalence, Predictors, andConsequences of Late Nephrology Referral at a Tertiary Care Center. J Am SocNephrol. 1999 Jun;10(6):81–6.
2. SaranR, Robinson B, Abbott KC, Bragg-Gresham J, Chen X, Gipson D, et al. US RenalData System 2019 Annual Data Report: Epidemiology of Kidney Disease in theUnited States. American Journal of Kidney Diseases. 2020 Jan;75(1):A6–7.
3. ChandrashekarA, Ramakrishnan S, Rangarajan Dr. Survival analysis of patients on maintenancehemodialysis. Indian J Nephrol. 2014;24(4):206–13.
4. LokCE, Huber TS, Lee T, Shenoy S, Yevzlin AS, Abreo K, et al. KDOQI ClinicalPractice Guideline for Vascular Access: 2019 Update. American Journal of KidneyDiseases. 2020 Apr;75(4):S1–164.
5. UhO. Analysis of internal jugular catheter (IJC) inserted by a nephrologist forhaemodialysis in a kidney care center in Nigeria. 2018;1(1):01–7.
6. OliverMJ, Callery SM, Thorpe KE, Schwab SJ, Churchill DN. Risk of bacteremia fromtemporary hemodialysis catheters by site of insertion and duration of use: Aprospective study. Kidney International. 2000 Dec;58(6):2543–5.
7. KherV. End-stage renal disease in developing countries. Kidney International. 2002Jul;62(1):350–62.
8. TaylorG, Gravel D, Johnston L, Embil J, Holton D, Paton S, et al. Incidence ofbloodstream infection in multicenter inception cohorts of hemodialysispatients. American Journal of Infection Control. 2004 May;32(3):155–60.
9. LeeT, Barker J, Allon M. Tunneled Catheters in Hemodialysis Patients: Reasons andSubsequent Outcomes. American Journal of Kidney Diseases. 2005 Sep;46(3):501–8.
10. Vats HS. Complications of Catheters: Tunneled andNontunneled. Advances in Chronic Kidney Disease. 2012 May;19(3):188–94.
11. Raad I. Intravascular-catheter-related infections. TheLancet. 1998 Mar;351(9106):893–8.
12. Mendu ML, May MF, Kaze AD, Graham DA, Cui S, Chen ME, et al.Non-tunneled versus tunneled dialysis catheters for acute kidney injuryrequiring renal replacement therapy: a prospective cohort study. BMC Nephrol.2017 Dec;18(1):351–7.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 120
All consecutive incident CKD5 patients initiating Hemodialysis in Dialysis Unit, Dept of Nephrology, Dr RML Hospital, New Delhi will be included in the Study.
Patients under 18 years of Age Patients Opting for Peritoneal Dialysis as the initial modality Dialysis requiring Acute Kidney Disease patients CKD 5 patients requiring urgent initiation of HD for hyperkalemia, intractable fluid overload, intractable acidosis, uremic encephalopathy and uremic pericarditis Patients initiating Hemodialysis with Non Tunneled Femoral Catheters Patients initiating Hemodialysis with Arterio Venous Fistula or Arterio Venous Graft Patients not giving consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Catheter Survival (Time period between insertion and its removal) 1.Catheter Survival (Time period between insertion and its removal) 2.Catheter Cost Analysis 1.Catheter Survival (Time period between insertion and its removal) 3.Prevalent indications of Catheter Removal - Infections, Mechanical Failure, bleeding related complications, Construction of a permanent vascular access i.e. AVF or AVG, Kidney Transplant 1.Catheter Survival (Time period between insertion and its removal)
- Secondary Outcome Measures
Name Time Method 1. Death from any cause 2. Patient undergoes Kidney Transplant
Trial Locations
- Locations (1)
Dr RML Hospital, ABVIMS, New Delhi
🇮🇳Central, DELHI, India
Dr RML Hospital, ABVIMS, New Delhi🇮🇳Central, DELHI, IndiaDr Abhisek GautamPrincipal investigator9064125620abhisekgautam23@gmail.com