TauroLock™-Hep500 for Maintenance of Central Venous Catheters in Adult Haemodialysis Patients

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Aim

The purpose of this guideline is to ensure that Taurolock™-HEP 500 line locks are used safely and appropriately to prevent catheter related bloodstream infections and maintain patency of central venous catheters in haemodialysis patients.

Introduction

Patients receiving haemodialysis must have vascular access in order for blood to be removed and returned to the patient via an extracorporeal circuit, to allow dialysis to take place. Arterio-venous fistulae (AVF) are the preferred form of access but central venous catheters (CVC) may be inserted as a temporary measure for acute kidney injury or while waiting for a fistula to mature. More commonly, central venous catheters are being used as permanent access for those patients whose fistula has failed, or, for those whose blood vessels are inadequate to attempt AVF creation1. In order for haemodialysis to take place it is imperative that the patency of vascular access is maintained.

Microbial colonisation of a haemodialysis catheter can cause catheter related bloodstream infections (CRBSI) through spread of infection from the catheter into the bloodstream. It is  relatively common and can increase hospital costs and patient length of stay. It is also a significant cause of morbidity and mortality among haemodialysis patients. The Renal Association recommends that an antimicrobial or antibiotic lock solution be used to reduce catheter related bacteraemia and other infections, for patients where central venous catheters must be used2. The active ingredients in the lock help prevent clotting, reduce the risk of infection and prevent the formation of biofilm, thus, improving the patency of the catheter. The volume of the lock must be exactly equal to the fill volume of each lumen of the CVC. This is to ensure that the lock fills the catheter but does not deliver a systemic dose to the patient. The lock is then left in the catheter until the next haemodialysis treatment.

TauroLock™-HEP500 - General Information

Indications:

TauroLock™-HEP500 is indicated for those patients who use a port or a silicone or polyurethane catheter-based device for their vascular access. TauroLock ™-HEP500 is intended to be used as a catheter lock solution. It is to be instilled into the device at the end of dialysis and withdrawn prior to initiating subsequent treatments.

Actions and Uses:

TauroLock™-HEP500 is instilled into the device lumen between treatments to reduce clot formation within the internal flow passages and to create a hostile environment to bacterial and fungal growth. The solution must be aspirated from the lumen prior to initiating the next treatment. Its ingredients include taurolidine, citrate 4% and heparin 500units/ml. Taurolidine is a broad spectrum antibiotic and antiendotoxin, which provides cover against gram-positive and gramnegative organisms, anaerobes and fungi. Citrate is used as an anticoagulant but can also help improve antimicrobial activity. Heparin is included to further improve patency of the line.

Availability:

TauroLock ™-HEP500 is supplied from Raigmore Pharmacy department as 10x5ml ampoules (single use). [100 x 10 mL TauroLock™-HEP500 vials (multi dose container-must be used within 48 hours of puncturing) are also available but are not currently stocked by Raigmore Pharmacy department].

Precautions:
  1. TauroLock ™-HEP500 is not for systemic injection. TauroLock ™-HEP500 must be used as a catheter lock solution as described in the access device’s instructions for use. Failure to adhere to these instructions may result in inadvertent systemic injection of the solution. Once instilled into the catheter the solution must not be used again after aspiration.
  2. The ampoule is for single dose only due to potential risk of contamination.
  3. Some patient populations even when using TauroLock ™-HEP500 antimicrobial solution may experience blood clots in the catheter lumen. In the event that access device patency is compromised follow local policy for restoring flow.
  4. In access devices which were blocked regularly with non –antimicrobial lock solutions (e.g. with heparin, low concentrated citrate or saline) prior to application of TauroLock ™-HEP500, viable organisms and endotoxins may be released from the biofilm. The lock solution must be aspirated before the next treatment to prevent very rare anaphylaxis reactions to these organisms or endotoxins.
  5. Concentration of the antimicrobial compound is near to saturation. If not stored or transported according to the storage instruction, precipitation may occur in the product. The product is supplied as a clear solution-Do not use if product looks precipitated.
Adverse Effects:

To date, there are no known adverse effects in humans due to the active ingredient concentrations in TauroLock ™-HEP500 when used as directed. There are no known risks associated with concomitant systemic antibiotic therapy or exposure to magnetic fields. TauroLock ™-HEP500 may cause mild hypocalcaemic symptoms if instillation is not done slowly as directed.

Contra-indications:

TauroLock ™-HEP500 is contraindicated for patients with a known allergy to (cyclo)-taurolidine, citrate or heparin (mucosa) or when a patient is currently taking medication with known adverse interaction to citrate, heparin or (cyclo)-taurolidine. TauroLock ™-HEP500 is also contraindicated for patients with heparin-induced thrombocytopenia or increased bleeding risk. Due to a lack of data, TauroLock ™-HEP500 should not be used during pregnancy or breastfeeding.

Storage:

TauroLock ™-HEP500 must be stored at a temperature of 15 to 30°C. Do not freeze.

TauroLock™-HEP500- administration

Administration
  1. TauroLock ™-HEP500 should be instilled to all CVCs following disconnection from the haemodialysis machine at the end of dialysis. Exceptions include patients in whom a Urokinase lock is indicated due to poor flow as per local policy ‘Protocol for the administration of urokinase for poor blood flow in tunnelled central venous catheters in haemodialysis patients’
    http://intranet.nhsh.scot.nhs.uk/PoliciesLibrary/Documents/Protocol%20for%20the%20Administration%20of%20Urokinase%20in%20Tunnelled%20CVCs.pdf
  2. Prior to instilling the line lock the CVC connection must be decontaminated according to the renal unit policy ‘procedure for connection and disconnection from HD’  http://intranet.nhsh.scot.nhs.uk/PoliciesLibrary/Documents/Procedure%20for%20Connection%20and%20Disconnection%20of%20Haemodialysis%20Treatment.pdf
  3. TauroLock ™-HEP500 must be prescribed on the patient’s drug chart or in the renal electronic prescription (HERMES) and this prescription must be signed off by two registered nurses prior to administration.
  4. Flush the device with 10ml saline, then instill TauroLock ™-HEP500 slowly, into the line, using an appropriate syringe, in a quantity sufficient to fill the lumen completely.
  5. TauroLock ™-HEP500 must be aspirated and discarded prior to the start of the next dialysis session. In the event that the lock cannot be aspirated from the lumen then it may be slowly injected into the patient’s blood stream at a rate not more than one ml per second provided that the bleeding risk (due to instillation of the heparin) has been assessed by a medical practitioner4

References

1. Thomas, N. (2008),Renal Nursing. (3rd edition).London. Balliere Tindall pp 193-194
2. UK Renal Association, Clinical Practice Guideline: Vascular access for haemodialysis
3. Taurolock HEP500 – Instructions for use product leaflet (43702/31/14). Prepared by TauroPharm GmbH, Date: 31st July 2014
4. www.taurolock.com FAQ/ Taurolock. Accessed on 05/06/2017

Last reviewed: 28 February 2018

Next review: 28 February 2021

Author(s): Pharmacist and Clinical Educator

Version: 1

Approved By: Policies, Procedures and Guidelines Subgroup of ADTC

Reviewer Name(s): Clinical Educator

Document Id: TAM468