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临床试验/CTRI/2025/04/085363
CTRI/2025/04/085363尚未招募3 期

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 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年5月3日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
To study the incidence of Central Line-Associated Bloodstream Infections (CLABSI)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • 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.

结局指标

主要结局

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

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

次要结局

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

研究者

发起方
DrNavin B
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Navin B

Government Stanley Medical College

研究点 (1)

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