| 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
|
|
|
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
|
|
|
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. |