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CTRI Number  CTRI/2021/04/032680 [Registered on: 08/04/2021] Trial Registered Prospectively
Last Modified On: 17/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Short Term Comparison between two types of Hemodialysis Catheters - Non Tunneled Jugular and Tunneled Jugular 
Scientific Title of Study   Comparative outcome of Tunnelled and Non-tunnelled Central Venous Haemodialysis Catheter survival during First Twelve Weeks of Incident Haemodialysis Patients 
Trial Acronym  CACOS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Himansu Sekhar Mahapatra 
Designation  HOD, Dept Of Nephrology, RML Hospital, New Delhi 
Affiliation  ABVIMS,Dr RML Hospital, New Delhi 
Address  307 - Dept Of Nephrology, RML Hospital, New Delhi

New Delhi
DELHI
110001
India 
Phone  9968474805  
Fax    
Email  hsmnephro@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhisek Gautam 
Designation  Senior Resident, Dept of Nephrology, RML Hospital 
Affiliation  ABVIMS, Dr RML Hospital, New Delhi 
Address  307 - Dept of Nephrology, RML Hospital, New Delhi

New Delhi
DELHI
110001
India 
Phone  9064125620  
Fax    
Email  abhisekgautam23@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhisek Gautam 
Designation  Senior Resident, Dept of Nephrology, RML Hospital 
Affiliation  ABVIMS, Dr RML Hospital, New Delhi 
Address  307 - Dept of Nephrology, RML Hospital, New Delhi

New Delhi
DELHI
110001
India 
Phone  9064125620  
Fax    
Email  abhisekgautam23@gmail.com  
 
Source of Monetary or Material Support  
Dr. Ram Manohar Lohia Hospital and Atal Bihari Vajpayee Institute of Medical Science (ABVIMS) 
 
Primary Sponsor  
Name  Dr RML Hospital and ABVIMS 
Address  Dr Ram Manohar Lohia Hospital, Baba Kharak Singh Marg, New Delhi 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhisek Gautam  Dr RML Hospital, ABVIMS, New Delhi  Dr RML Hospital, ABVIMS, Baba Kharak Singh Marg, New Delhi
Central
DELHI 
9064125620

abhisekgautam23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee, ABVIMS,Dr RML Hospital, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Non Tunneled Internal Jugular Catheter  Eli- Cath Polyurethane Radiopaque Double Lumen Curved Un-cuffed Catheters 11.5 Fr x 13.5 cm will be inserted in our Major Operation Theatre in the Dialysis room taking all precautions and following steps as mentioned in our protocol. Post procedure Chest X Ray will be done to confirm location of the catheter tip in the right atrium 
Comparator Agent  Tunneled Internal Jugular Catheter  Meditech Maxima Chronic Dual Lumen Straight Carbothane cuffed catheter 14.5 Fr, 28 cm length will be inserted in our Major Operation Theatre in the Dialysis room taking all precautions and following steps as mentioned in our protocol. Tunneled catheter will be inserted using flouroscopic guidance. Post procedure Chest X Ray will be done to confirm location of the catheter tip in the right atrium 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All consecutive incident CKD5 patients initiating Hemodialysis in Dialysis Unit, Dept of Nephrology, Dr RML Hospital, New Delhi will be included in the Study 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Catheter Survival (Time period between insertion and its removal)
2.Catheter Cost Analysis
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  
Outcome  TimePoints 
1. Death from any cause
2. Patient undergoes Kidney Transplant
3. Initiation of Arterio Venous Fistula or Arterio Venous Graft 
1.0 weeks - baseline
2.4 weeks - first follow up
3.8 weeks - second follow up
4.12 weeks - third follow up 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/04/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Haemodialysis continues to be the Renal Replacement therapy of choice in End Stage Renal Disease Patients. Vascular access is an integral and important aspect for ESRD patients being started on Chronic Haemodialysis treatments.  Preliminary data from the Dialysis Outcomes and Practice patterns showed that 14 % of patients in Europe and 34 % of patients 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 for Dialysis are more likely to begin Dialysis using an Acute Dialysis Catheter.(1)Despite the continuous improvement of dialysis technology and pharmacological treatment, mortality rates for dialysis patients are still high. Cardiovascular death and infections remain the leading cause of mortality in Dialysis populations.(2,3)

There is inadequate evidence for the KDOQI to make any recommendations on incident vascular access. The evidence for the associations between mortality and all cause hospitalizations and incident vascular 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 with tunnelled CVC.(4) These statements while valid however present a problem in real time management in low income countries where patients are often unable to afford the necessary costs required for inserting a tunnelled central venous catheter. In a study done in Nigeria that prospectively followed the outcomes of Internal Jugular Vein Catheterization with both tunnelled and non-tunnelled catheters, a non-tunnelled catheter could be used for a duration of 1-8 weeks with catheter related bacteraemia being the limiting factor for removal.(5)Another Study done in Canada prospectively followed patients with un-cuffed Internal Jugular Catheters inserted for dialysis purpose and reported only 5.4 % incidence in bacteraemia after 3 weeks of usage.(6) This was against the KDOQI guideline at the time which recommended catheter usage for 21 days at the Internal Jugular Site. Current KDOQI guidelines recommend CVC usage at the Internal Jugular site for less than 2 weeks. This recommendation however is largely based on expert opinions and there are no large prospective studies done to study risk of bacteraemia and catheter removal rates in the haemodialysis population.

More than 65% of patients of chronic kidney disease (CKD)present as end-stage renal disease (ESRD) to  nephrologists in India.(7) Hence it is difficult for any systematic planning in ESRD patients to be done for a Permanent Vascular Access. Majority of patients often start dialysis on an emergency basis either with Jugular or Femoral un-cuffed catheters with a permanent vascular access planned later after stabilization of their clinical status. As such a number of Patients in the low-income group are unable to afford placement and care of Tunnelled Jugular Catheters which come at a much higher price than non-tunnelled Catheters. With the market cost of Tunnelled Jugular Catheters ranging from 7000 to 32,000 Rupees, along with the cost of medication and investigations the financial burden on a CKD 5D patient from a lower income group is substantial. Non Tunnelled Jugular catheters on the other hand are relatively cheaper within the price range of 1200 – 1800 Rupees placing less of a financial burden on poor patients. Therelative risk of(1) TVC’s causing bacteraemia in patients is approximately ten times higher than the risk of bacteraemiain patients with AV fistula. (7)The risk of infection-related hospitalization/mortality is 2–3 fold higher with TVC’s incomparison to AV  Fistula.(8)The cumulative risk of CRBSI was 35% at 3 months and 48% at 6 months in one study.(9)Studies have also shown that Non Tunnelled Hemodialysis Catheters have a 5 fold greater risk of infection than Tunnelled Hemodialysis Catheters.(10,11) Considering the high risks of CRBSI along with the cost for Tunnelled IJV Catheters, it is imperative to have a lower cost solution as dialysis access for this population group which provides adequate dialysis for Patients till the time an AVF is constructed and matures.

This Study Aims to compare Catheter related Outcomes between Tunnelled and Non Tunnelled IJV Catheters in terms of Catheter Removal Rates and AVF construction. The Aim being to prove that Non Tunnelled Jugular Catheters can be a low cost stable vascular access for more than2 weeks for a patient awaiting AVF construction and maturation and become a viable option for low income group patients in India who cannot afford Tunnelled Jugular Catheters for Dialysis.

REFERENCES

1.             Arora P, Obrador GT, Ruthazer R, Kausz AT, Meyer KB, Jenuleson CS, et al. Prevalence, Predictors, and Consequences of Late Nephrology Referral at a Tertiary Care Center. J Am Soc Nephrol. 1999 Jun;10(6):81–6.

2.             Saran R, Robinson B, Abbott KC, Bragg-Gresham J, Chen X, Gipson D, et al. US Renal Data System 2019 Annual Data Report: Epidemiology of Kidney Disease in the United States. American Journal of Kidney Diseases. 2020 Jan;75(1):A6–7.

3.             Chandrashekar A, Ramakrishnan S, Rangarajan Dr. Survival analysis of patients on maintenance hemodialysis. Indian J Nephrol. 2014;24(4):206–13.

4.             Lok CE, Huber TS, Lee T, Shenoy S, Yevzlin AS, Abreo K, et al. KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update. American Journal of Kidney Diseases. 2020 Apr;75(4):S1–164.

5.             Uh O. Analysis of internal jugular catheter (IJC) inserted by a nephrologist for haemodialysis in a kidney care center in Nigeria. 2018;1(1):01–7.

6.             Oliver MJ, Callery SM, Thorpe KE, Schwab SJ, Churchill DN. Risk of bacteremia from temporary hemodialysis catheters by site of insertion and duration of use: A prospective study. Kidney International. 2000 Dec;58(6):2543–5.

7.             Kher V. End-stage renal disease in developing countries. Kidney International. 2002 Jul;62(1):350–62.

8.             Taylor G, Gravel D, Johnston L, Embil J, Holton D, Paton S, et al. Incidence of bloodstream infection in multicenter inception cohorts of hemodialysis patients. American Journal of Infection Control. 2004 May;32(3):155–60.

9.             Lee T, Barker J, Allon M. Tunneled Catheters in Hemodialysis Patients: Reasons and Subsequent Outcomes. American Journal of Kidney Diseases. 2005 Sep;46(3):501–8.

10.          Vats HS. Complications of Catheters: Tunneled and Nontunneled. Advances in Chronic Kidney Disease. 2012 May;19(3):188–94.

11.          Raad I. Intravascular-catheter-related infections. The Lancet. 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 injury requiring renal replacement therapy: a prospective cohort study. BMC Nephrol. 2017 Dec;18(1):351–7.

 
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