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

NCT01394458 | Completed DMC

• 1 other identifier: Al452-0005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Catheter Related Infection; Bacteremia

Keywords

catheter related infection; bacteremia; hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Rate of catheter-related infections per 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.

  6 months

• Rate of catheter dysfunction / 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.

  6 months

• Rate of alteplase use / 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin.

  6 months

Study Arms (2)

30 % ethanol/ 4 % sodium citrate group

EXPERIMENTAL

For patients randomized to the 30% ethanol /4 % sodium citrate group, the lock solution will be provided in pre-filled syringes for single use only. After each dialysis session, the locking solution will be instilled into both catheter lumens, the lumens clamped and caps tightly secured to the hubs. Any remaining 30% ethanol/4% sodium citrate solution in each syringe will be discarded. The locking solution will be withdrawn from the catheter lumens before the next dialysis session.

Other: 30 % ethanol / 4% sodium citrate catheter locking solution

Heparin 1000 U/ml

EXPERIMENTAL

For patients randomized to the heparin group, the heparin will be provided in 10 ml glass vials. Two, 3 ml syringes will be used to draw up the required volume of heparin to fill each lumen. A separate syringe will be used to fill each catheter lumen. The necessary volume should match the lumen volume with no overfill. The locking solution will be instilled into both catheter lumens, the lumens clamped and caps tightly secured to the hubs. The locking solution will be withdrawn from the catheter lumens before the next dialysis session.

Drug: Heparin 1000 u / ml

Interventions

30 % ethanol / 4% sodium citrate catheter locking solution OTHER

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.

Also known as: Citra Lok Plus

30 % ethanol/ 4 % sodium citrate group

Heparin 1000 u / ml DRUG

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.

Heparin 1000 U/ml

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• MED XL Inc: collaborator
• Winnipeg Regional Health Authority: collaborator

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Related Publications (1)

• Vercaigne LM, Allan DR, Armstrong SW, Zacharias JM, Miller LM. An ethanol/sodium citrate locking solution compared to heparin to prevent hemodialysis catheter-related infections: a randomized pilot study. J Vasc Access. 2016 Jan-Feb;17(1):55-62. doi: 10.5301/jva.5000486. Epub 2015 Dec 7.

  PMID: 26660041 DERIVED

MeSH Terms

Conditions

Catheter-Related Infections; Bacteremia

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Lavern Vercaigne, Pharm.D.

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Lisa Miller, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Faculty of Pharmacy

Study Record Dates

• First Submitted: July 4, 2011
• First Posted: July 14, 2011
• Study Start: August 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 4, 2015

Record last verified: 2015-12

Locations

CA (1)