Efficacy and Safety of an Ethanol/Sodium Citrate Locking Solution: A Pilot Study - Full Text View

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:

MedlinePlus related topics: Blood Thinners Dialysis

Drug Information available for: Sodium citrate Heparin

U.S. FDA Resources

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
Estimated Study Completion Date:	November 2013
Estimated 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.

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

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:	June 14, 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
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Ethanol
Calcium heparin
Citric Acid
Heparin
Anti-Infective Agents, Local

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Anticoagulants
Hematologic Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 17, 2013