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

This study has been completed.
Sponsor:
Collaborators:
MED XL Inc
Winnipeg Regional Health Authority
Information provided by (Responsible Party):
Dr. Lavern M. Vercaigne, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01394458
First received: July 4, 2011
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Catheter Related Infection
Bacteremia
Other: 30 % ethanol / 4% sodium citrate catheter locking solution
Drug: Heparin 1000 u / ml

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Efficacy and Safety of an Ethanol/Sodium Citrate Locking Solution to Prevent Hemodialysis Catheter-Related Infections: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Documentation of Serious Adverse Events (SAE) with the use of a 30% ethanol / 4% sodium citrate catheter locking solution. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    This outcome will monitor the safety of the ethanol/sodium citrate catheter locking solution.


Secondary Outcome Measures:
  • Rate of catheter-related infections per 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Rate of catheter dysfunction / 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Catheter function, defined as blood flow <300 ml/min for 50% of each dialysis session over two consecutive sessions, will be monitored prospectively.

  • Rate of alteplase use / 1000 catheter days with the 30% ethanol / 4% sodium citrate catheter locking solution compared to heparin. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Need for alteplase use to manage dysfunctional catheters will be documented.


Enrollment: 40
Study Start Date: August 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 30 % ethanol/ 4 % sodium citrate group
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
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.
Other Name: Citra Lok Plus
Experimental: Heparin 1000 U/ml
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
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394458

Locations
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Sponsors and Collaborators
University of Manitoba
MED XL Inc
Winnipeg Regional Health Authority
Investigators
Principal Investigator: Lavern Vercaigne, Pharm.D. University of Manitoba
Principal Investigator: Lisa Miller, MD University of Manitoba
  More Information

No publications provided

Responsible Party: Dr. Lavern M. Vercaigne, Professor, Faculty of Pharmacy, University of Manitoba
ClinicalTrials.gov Identifier: NCT01394458     History of Changes
Other Study ID Numbers: Al452-0005
Study First Received: July 4, 2011
Last Updated: November 22, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
catheter related infection
bacteremia
hemodialysis

Additional relevant MeSH terms:
Bacteremia
Catheter-Related Infections
Communicable Diseases
Infection
Bacterial Infections
Inflammation
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome
Calcium heparin
Citric Acid
Ethanol
Heparin
Pharmaceutical Solutions
Anti-Infective Agents
Anti-Infective Agents, Local
Anticoagulants
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Chelating Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Sequestering Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014