Skip to main content
Clinical Trials/CTRI/2025/04/085363
CTRI/2025/04/085363Not yet recruitingPhase 3

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)

DrNavin B1 site in 1 country90 target enrollmentStarted: May 3, 2025Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
90
Locations
1
Primary Endpoint
To study the incidence of Central Line-Associated Bloodstream Infections (CLABSI)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • All incident patients undergoing insertion of first time non tunnelled hemodialysis catheter in the Haemodialysis Centre at Stanley medical college were screened and included.

Exclusion Criteria

  • Exclusion criteria:
  • Patients below 18 years
  • Recent COVID 19 infection patients on anticoagulation treatment,
  • INR more than 1.4,
  • Platelets less than 60 × 109 /l,
  • Clinical symptoms of infection, known malignancy,
  • Bleeding complication in the four weeks before catheter insertion,
  • Known allergy or intolerance to Tenecteplase or heparin ,
  • Pregnancy or breastfeeding.

Outcomes

Primary Outcomes

To study the incidence of Central Line-Associated Bloodstream Infections (CLABSI)

Time Frame: Blood cultures will be taken if the patient develops fever/chills during the Hemodialysis session or any discharge from the Central line site

Secondary Outcomes

  • To study the incidence of catheter malfunction/obstruction.(The blood flow achieved (and sustained) during the dialysis session was logged.)

Investigators

Sponsor
DrNavin B
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Navin B

Government Stanley Medical College

Study Sites (1)

Loading locations...

Similar Trials