Efficacy and Safety of an Ethanol/Sodium Citrate Locking Solution: A Pilot Study

Bacteremia Clinical Trial

Official title:

Efficacy and Safety of an Ethanol/Sodium Citrate Locking Solution to Prevent Hemodialysis Catheter-Related Infections: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394458
• Other study ID #: Al452-0005
• Status: Completed
• Phase: N/A
• First received: July 4, 2011
• Last updated: December 3, 2015
• Start date: August 2011
• Est. completion date: November 2013

Study information

• Verified date: December 2015
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

Currently in Canada, either 4% sodium citrate or heparin 1,000-10,000 U/ml solutions are "locked" into hemodialysis catheters between dialysis sessions to prevent thrombosis. The use of an ethanol/sodium citrate locking solution may have advantages over either of these agents alone. The investigators hypothesize that the 30 % ethanol/4% sodium citrate catheter locking solution is safe and effective in the prevention of catheter-related infections and thrombosis.

Description:

The pilot study will utilize a prospective, randomized design. After meeting the inclusion/exclusion criteria and providing written informed consent, patients will be randomly assigned to a 30 % ethanol/ 4% sodium citrate locking solution or heparin 1000 U/ml. Patients will be enrolled from the Health Sciences Centre and the Sherbrook Dialysis Units in Winnipeg, Manitoba, Canada.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with Stage V chronic kidney disease preparing to start hemodialysis

• Exchange of an existing catheter to a cuffed, tunneled catheter OR planned vascular access with a cuffed, tunneled catheter

• CVC used for hemodialysis made of alcohol-resistant polymers ie. carbothane

Exclusion Criteria:

• Patients receiving catheters not made of alcohol resistant polymers

• Critically ill patients in ICU setting

• Patients with acute renal failure, who will likely not require prolonged vascular access ( ie. > months)

• Patients with maturing fistulas/graft creation within 2 months

• Patients with planned antibiotic treatment courses lasting longer than 4 weeks from the date of new catheter insertion

• Patients receiving a new cuffed, tunneled catheter over a guide wire, if a fibrin sheath angioplasty was not performed after removing the previous dysfunctional catheter

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacteremia
• Catheter Related Infection
• Catheter-Related Infections
• Infection

Intervention

Other:
• 30 % ethanol / 4% sodium citrate catheter locking solution
This solution is locked into the lumens of hemodialysis catheters between treatments to prevent infection and thrombosis. Before each dialysis session, the solution should be removed and discarded.

Drug:
• Heparin 1000 u / ml
In the control group, heparin 1000 u / ml will be locking into the hemodialysis catheters between treatments to prevent thrombosis. The heparin solution should be removed and discarded before each dialysis session.

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
University of Manitoba	MED XL Inc, Winnipeg Regional Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Documentation of Serious Adverse Events (SAE) with the use of a 30% ethanol / 4% sodium citrate catheter locking solution.	This outcome will monitor the safety of the ethanol/sodium citrate catheter locking solution.	6 months	Yes
Secondary	Rate of catheter-related infections per 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.	This outcome will primarily investigate efficacy of the ethanol/sodium citrate locking solution and help to describe effect size for the design of a larger more definitive study.	6 months	No
Secondary	Rate of catheter dysfunction / 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.	Catheter function, defined as blood flow <300 ml/min for 50% of each dialysis session over two consecutive sessions, will be monitored prospectively.	6 months	No
Secondary	Rate of alteplase use / 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.	Need for alteplase use to manage dysfunctional catheters will be documented.	6 months	No