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CTRI Number  CTRI/2025/04/085363 [Registered on: 23/04/2025] Trial Registered Prospectively
Last Modified On: 22/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing Different Catheter Locking Solutions to Prevent Bloodstream Infections in Patients with Central Lines 
Scientific Title of Study   Efficacy Of Recombinant Tissue Plasminogen Activator(Rt-PA)Tenecteplase, Sodium Bicarbonate Over Heparin As a Locking Solution In Prevention Of Central Line-Associated Bloodstream Infections (CLABSI) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Navin B 
Designation  Nephrology DM Resident 
Affiliation  Government Stanley Medical College 
Address  Department of Nephrology, G block(NTB)-3rd floor, Government Stanley Medical College 1,Old jail road, Chennai-600001

Chennai
TAMIL NADU
600001
India 
Phone  9677009348  
Fax    
Email  navinb90@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.M.Edwin Fernando 
Designation  Professor & Head of the Department(Nephrology) 
Affiliation  Government Stanley Medical College 
Address  Department of Nephrology, G block(NTB)-3rd floor, Government Stanley Medical College 1,Old jail road, Chennai-600001

Chennai
TAMIL NADU
600001
India 
Phone  9841018717  
Fax    
Email  nephroeddy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Navin B 
Designation  Nephrology DM Resident 
Affiliation  Government Stanley Medical College 
Address  Department of Nephrology, G block(NTB)-3rd floor, Government Stanley Medical College 1,Old jail road, Chennai-600001


TAMIL NADU
600001
India 
Phone  9677009348  
Fax    
Email  navinb90@gmail.com  
 
Source of Monetary or Material Support  
Department of Health Research-ICMR Ministry of Health and Family Welfare Government of India 
Government Stanley Medical College Hospital, Old Jail Road, Chennai 600001 
 
Primary Sponsor  
Name  DrNavin B 
Address  Department of Nephrology, G block(NTB)-3rd floor, Government Stanley Medical College, 1,Old Jail Road,Chennai-600001 
Type of Sponsor  Other [Self] 
 
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 Navin B  Government Stanley Medical College Hospital  Hemodialysis Unit, Department of Nephrology, G block(NTB)-3rd floor 1, Old Jail Road, Chennai 600001
Chennai
TAMIL NADU 
9677009348

navinb90@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-Stanley Medical College  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 
Comparator Agent  7.5% sodium bicarbonate solution  Each lumen of HD catheter(non tunnelled, non cuffed) is flushed with 5ml of 7.5% sodium bicarbonate solution after each HD session(weekly twice or thrice) till the removal of the HD catheter. 
Intervention  Recombinant Tissue Plasminogen Activator(Rt-PA)Tenecteplase  GROUP B: Rt-PA :Tenecteplase 1mg/ml, volume adjusted with saline to match the lumen of HD catheter(non tunnelled, non cuffed)- 1mg in each lumen after each HD session(weekly twice or thrice)- till the removal of that catheter 
Comparator Agent  Unfractionated Heparin  GROUP A: Heparin 5000 units per millilitre,full luminal volume -5000units in each lumen of HD catheter(non tunnelled, non cuffed), after each session of HD(weekly twice or thrice) till the removal of the catheter 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All incident patients undergoing insertion of first time non tunnelled hemodialysis catheter in the Haemodialysis Centre at Stanley medical college were screened and included 
 
ExclusionCriteria 
Details  Exclusion criteria:
1. Patients below 18 years
2. Recent COVID 19 infection patients on anticoagulation treatment,
3. INR more than 1.4,
4. Platelets less than 60 × 109 /l,
5. Clinical symptoms of infection, known malignancy,
6. Bleeding complication in the four weeks before catheter insertion,
7. Known allergy or intolerance to Tenecteplase or heparin ,
8. Pregnancy or breastfeeding. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the incidence of Central Line-Associated Bloodstream Infections (CLABSI)  Blood cultures will be taken if the patient develops fever/chills during the Hemodialysis session or any discharge from the Central line site 
 
Secondary Outcome  
Outcome  TimePoints 
To study the incidence of catheter malfunction/obstruction.   The blood flow achieved (and sustained) during the dialysis session was logged.
 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   Phase 3 
Date of First Enrollment (India)   03/05/2025 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
BACKGROUND:
Central venous catheters (CVCs), originally introduced for short-term dialysis, have become an acceptable form of permanent vascular access.CVCs evolved as a bridge to optimal management in hemodialysis (HD) patients who await arterio-venous fistula (AVF) maturation as well as a solution for patients who have no alternate access.Despite great advances, two major causes of catheter loss continue to plague sustained effective HD treatment due to catheter-related bloodstream infection (CLABSI).
The colonization of the intraluminal space through the catheter hub or following a bacteremia episode is accepted as the more likely pathogenesis of CLABSI for long-term catheters (intraluminal hypothesis) . Biofilms that harbor
microorganisms are demonstrated on external and internal surfaces of indwelling catheters for both cuffed and uncuffed catheters as early as 24 h after their insertion . These biofilms are mostly responsible for the treatment failures in CLABSI, because their protein–fibrin ultrastructure prevents optimum antibiotic exposure, providing a niche for the microorganisms.
Infection related to central venous catheters is also associated with adverse health outcomes and high health care costs.Indeed, catheter-related sepsis is one of the
most common causes of death in patients undergoing hemodialysis.

PURPOSE OF THIS STUDY:
To prevent CLABSI, various pharmacological agents are instilled into the arterial and venous ports of hemodialysis catheters. Heparin has been the traditional locking solution  widely used.
Recombinant tissue plasminogen activator (rt-PA) has been used primarily to treat catheter thrombosis. Although the relatively high cost of rt-PA and its theoretical potential to cause bleeding ,it has advantage of significantly improved blood flow rates, lower venous pressures, and fewer complications. Antibiotic locks demonstrated a reduction in CLABSI; however, there is growing concern that their overuse enables the development of antibiotic resistance., Wong et al.studied the effects of bicarbonate on blood coagulation. They suggested that removing bicarbonate chelated calcium ions from the coagulation pathway
required calcium as a cofactor. In doing so, the bicarbonate-mediated chelation of calcium ions indirectly inhibited the  conversion of fibrinogen to fibrin, leading to decreased clotting.
Sodium bicarbonate is inexpensive, safe and effective method in preventing HD catheter loss due to clot formation . NaHCO3 has been shown to inhibit bacterial proliferation by decreasing bacterial adherence and preventing biofilm formation.
However, evidence supporting the use of various locking solutions in HD catheters-mainly in non tunnelled non cuffed type - to achieve these objectives is limited.
 
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