Prophylaxis against gram negative and fungal infections in immunocompromised babies, children & young people with a Central Venous Access Device (CVAD)

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1. INTRODUCTION

Gram negative and fungal infections are a well recognised cause of morbidity and mortality in immunocompromised babies, children and young people. Both fungi and Gram negative bacteria are recognised environmental organisms.

The campus of the Queen Elizabeth University Hospital and the Royal Hospital for Children, Glasgow have had documented, environmentally acquired, infections in immunocompromised patients.

Prophylaxing against environmental fungal infections is standard practice and there are well established criteria for this. The group considered previous local guidance on prophylaxis within paediatric haemato-oncology, the European Organisation for Research and Treatment of Cancer (EORTC) and Infectious Diseases Society of America (IDSA) guidance and the recent guidance from the Health Protection Surveillance centre in Ireland. 

Prophylaxing against environmental Gram negative bacteria in children has a much smaller evidence base and there is no national or international consensus on whether or how this should be done. There is however published literature which shows the potential for using line locks to decrease the number of gram negative infections in children with cancer.

Standard technique in this document refers to turbulent push pause technique finishing with positive pressure.

2. RELATED DOCUMENTATION
  • GG&C Management of Line-related Sepsis in Adults and Children - Version 13
  • RHC-HAEM-ONC-011 - The Role of Phlebotomists
  • NHS GG&C Acute Division Intravenous Flush Policy 2015
  • Vascular Access Procedure and Practice Guideline 2019
3. AUTHORISED PERSONNEL/SPECIFIC STAFF COMPETENCIES

All medical staff, registered nurses, pharmacists, allied health professionals and phlebotomists need to be competent (appropriate to role) in the prescribing of, dispensing and administering prophylaxis.

4. EQUIPMENT/MATERIALS
  • TauroLock and TauroLock Hep 100 (Heparinised TauroLock 100iu/ml)
  • Sodium Chloride 0.9%
  • PPE
  • Syringes/Needles
  • Clinell wipes
  • Port Protector
  • Smartsites if require to be changed
5. PROCEDURE

5.1   Gram Negative Infection Prophylaxis:

General

All Central Venous Access Devices, Percutaneous Intravenous Catheters (PICs) Hickman Lines (Lines) and Port-a-Caths (Ports) should be locked as part of the Gram negative infection prophylaxis programme

Care and management of dialysis lines, ECMO, filter and exchange circuits are not covered in this SOP.

The maximum time permitted for a line lock to remain in situ is

ONE WEEK FOR HICKMAN LINES OR PIC LINES AND FOUR WEEKS FOR PORT – A - CATHS

Drug Storage

Two distinct TauroLock products will be kept as stock within the Haemato-oncology unit. Within the ward and day care areas, in order to minimise risk of incorrect drug selection, different storage conditions are in place for each product

  • TauroLock ( containing Taurolidine, Citrate 4%) 5ml ampoule
    For use in Hickman lines, PIC lines and Ports in regular use
    Stored in clean utility areas and drug cupboards
  • TauroLock Hep 100 (containing Taurolidine, Citrate 4%, Heparin 100iu/ml) 3ml ampoule
    For use in Ports only when removing the Gripper needle and locking the chamber(s)
    Stored in ward controlled drug cupboard.

Other areas will demonstrate physically separate storage options for the two products and these locations will form a core part of the associated prophylaxis training package.

Prescribing

A current prescription is required for every patient receiving TauroLock or TauroLock Hep 100. Refer to Appendix 1 for appropriate lock volumes

During an inpatient admission, the appropriate product should be prescribed on an inpatient prescription chart.

When a patient is attending the day care unit, or outpatient department the appropriate prescription chart should be generated or the previous chart retrieved.

POONs attending patients at home who require a line flush and lock must retrieve the appropriate prescription chart before their home visit.

 

5.2   Hickman Lines or PICs:

Inpatients

  1. If the Hickman line or PIC will not be accessed for the duration of the inpatient stay, the following procedure should only be necessary to change line locks in situ prior to discharge from the ward if it has been in situ for the maximum permissible duration of 1 week.
  2. Double lumen Hickman lines should have any lumen which is not being accessed locked as per procedure below. Both lumens must be locked prior to discharge.
  3. Take a discard of 2.5-5ml from the CVAD to remove any previous lock solution, each time it is accessed.
  4. Flush with 10 ml Sodium Chloride 0.9%, using standard technique, prior to line locking.
  5. For Hickman lines or PICs which are being accessed intermittently (e.g. for blood samples, drug administration, fluids or chemotherapy), follow steps 3 and 4 above before and after each intervention as per standard procedure. The line should then be locked using TauroLock, which will remain in situ until the lumen is next accessed.
  6. Prior to discharge, ensure Hickman line or PIC is locked with TauroLock, unless a different antibiotic lock has been requested by a consultant microbiologist.

Day Care Patients

  1. If the Hickman line or PIC will not be accessed for the duration of the day care stay, check patient notes and Kardex to determine how long the current line lock has been in situ. The following procedure should only be necessary to change the line lock if the current lock has been in situ for the maximum permissible duration of 1 week.
  2. Double lumen Hickman lines should have any lumen which is not being accessed locked as per procedure below. Both lumens must be locked prior to discharge.
  3. Take a discard of 2.5-5ml from the CVAD to remove any previous lock solution, each time it is accessed.
  4. Flush with 10 ml Sodium Chloride 0.9%, using standard technique, prior to line locking.
  5. If the Hickman line or PIC is to be accessed on multiple occasions during the day care stay (e.g. for GFR estimations or PK studies), the line does NOT need to be locked every time it is accessed. The line should be flushed with 10ml Sodium Chloride 0.9% using standard technique following each intervention. The line should only be locked using TauroLock when the patient is ready to leave day care.
  6. If the Hickman line or PIC is being accessed for blood samples which may subsequently lead to a requirement for further infusions or blood product support, the line should be locked with TauroLock pending results becoming available. If further intervention is required, follow steps 3 and 4 above before and after accessing the line. The line should then be locked with TauroLock when the patient is ready to leave day care
  7. For Hickman lines or PICs which are being accessed intermittently (e.g. for drug administration, fluids or chemotherapy), follow steps 3 and 4 above before and after each intervention as per standard procedure. The line should then be locked using TauroLock which will remain in situ until the lumen is next accessed, and when the patient is ready to leave day care.
  8. Prior to a patient leaving day care, ensure Hickman line or PIC is locked with TauroLock, unless a different antibiotic lock has been requested by a consultant microbiologist.

Outpatient Clinic

  1. If the Hickman line or PIC will not be accessed for the duration of the outpatient visit, check patient notes and Kardex to determine how long the current line lock has been in situ. The following procedure should only be necessary to change the line lock if the current lock has been in situ for the maximum permissible duration of 1 week.
  2. Double lumen Hickman lines should have any lumen which is not being accessed locked as per procedure below. Both lumens must be locked prior to discharge.
  3. Take a discard of 2.5-5ml from the CVAD to remove any previous lock solution, each time it is accessed.
  4. Flush with 10 ml Sodium Chloride 0.9%, using standard technique, prior to line locking.
  5. If the Hickman line or PIC is being accessed for blood samples which may subsequently lead to a requirement for further infusions or blood product support, the line should be locked with TauroLock pending results becoming available. If further intervention is required, the patients’ care will transfer to the day care unit. Follow steps 3 and 4 above before and after accessing the line. The line should then be locked with TauroLock when the patient is ready to leave the day care unit.
  6. For Hickman lines or PICs which are being accessed for chemotherapy, follow steps 3 and 4 above before and after drug administration as per standard procedure. The line should then be locked using TauroLock when the patient is ready to leave.

Home

  1. Patients who are at home with Hickman lines or PICs in situ should have these flushed and re-locked once a week by a Paediatric Oncology Outreach Nurse. Double lumen Hickman lines should have both lumens locked.
  2. POON must obtain the appropriate drug Kardex prior to each home visit
  3. Take a discard of 2.5-5ml from the CVAD to remove any previous lock solution, each time it is accessed.
  4. Flush with 10 ml Sodium Chloride 0.9%, using standard technique, prior to line locking.
  5. The line should then be locked using TauroLock.

 

5.3   PORT-A-CATHS (Ports):

Inpatients

TAUROLOCK HEP 100 WILL ONLY BE REQUIRED WHEN REMOVING GRIPPER NEEDLE OR IF PATIENT IS BEING DISCHARGED WITH GRIPPER NEEDLE REMAINING IN SITU

  1. If the Port is not be accessed for the duration of the inpatient stay, the following procedure should only be necessary to change the lock prior to discharge from the ward if the current lock has been in situ for the maximum permissible duration of 4 weeks.
  2. Double chamber Ports should have any chamber which is not to be accessed locked as per procedure below. Both chambers must be locked prior to discharge.
  3. Take a discard of 2.5-5ml from the CVAD to remove any previous lock solution, each time it is accessed.
  4. Flush with 10ml Sodium Chloride 0.9%, using standard percussive techniques, prior to port locking.
  5. For Ports which are being accessed intermittently (e.g. for blood samples, drug administration, fluids or chemotherapy), follow steps 3 and 4 above before and after each intervention as per standard procedure. The Port should then be locked using TauroLock, which will remain in situ until the device is next accessed.
  6. Prior to discharge, ensure Port is locked with TauroLock Hep 100 before removing gripper needle, unless a different antibiotic lock has been requested by a consultant microbiologist. If the gripper needle is remaining in situ on discharge lock with TauroLock Hep 100.

Day Care Patients

  1. If the Port will not be accessed for the duration of the day care stay, check patient notes and Kardex to determine how long the current lock has been in situ. The following procedure should only be necessary to change the lock if the current lock has been in situ for the maximum permissible duration of 4 weeks, or this time period will have elapsed prior to their next home visit/ return to hospital.
  2. Double chamber Ports should have any chamber which is not being accessed locked as per procedure below. Both chambers must be locked prior to discharge if the current lock has been in situ for the maximum permissible duration of 4 weeks.
  3. Take a discard of 2.5-5ml from the CVAD to remove any previous lock solution, each time it is accessed.
  4. Flush with 10 ml Sodium Chloride 0.9%, using standard technique, prior to port locking.
  5. Ports accessed on multiple occasions for GFR estimations or PK studies, do NOT need to be locked every time it is accessed. The port should be flushed with 10ml Sodium Chloride 0.9% using standard technique following each intervention. This is to ensure the assays are not contaminated. The port should only be locked using TauroLock Hep 100 when the patient is ready to leave day care.
  6. If the Port is being accessed for blood samples which may subsequently lead to a requirement for further infusions or blood product support, the port should be locked with TauroLock Hep 100 pending results becoming available. If further intervention is required, follow steps 3 and 4 above before and after accessing the port. The port should then be locked with TauroLock Hep 100 when the patient is ready to leave day care
  7. For Ports which are being accessed intermittently (e.g. for drug administration, fluids or chemotherapy), follow steps 3 and 4 above before and after each intervention as per standard procedure. The Port should then be locked using TauroLock, which will remain in situ until the device is next accessed. When the patient is ready to leave day care, Port should be locked using TauroLock Hep 100.
  8. Prior to a patient leaving day care, ensure Port is locked with TauroLock Hep 100, unless a different antibiotic lock has been requested by a consultant microbiologist.

Outpatient Clinic

  1. If the Port will not be accessed for the duration of the outpatient visit, check patient notes and Kardex to determine how long the current lock has been in situ. It should only be necessary to change the lock if the current lock will have been in situ for the permitted maximum of 4 weeks prior to the next home or hospital visit.
  2. Double chamber Ports should have any chamber which is not being accessed locked as per procedure below. Both chambers must be locked prior to discharge if the current lock has been in situ for the maximum permissible duration of 4 weeks.
  3. Take a discard of 2.5-5ml from the CVAD to remove any previous lock solution, each time it is accessed.
  4. Flush with 10 ml Sodium Chloride 0.9%, using standard technique, prior to port locking.
  5. If the Port is being accessed for blood samples which may subsequently lead to a requirement for further infusions or blood product support, the port should be locked with TauroLock Hep 100 pending results becoming available. If further intervention is required, the patients’ care will be transferred to the day care unit. Follow steps 3 and 4 above before and after accessing the port. The port should then be locked with TauroLock Hep 100 when the patient is ready to leave day care.
  6. For Ports which are being accessed for chemotherapy, follow steps 3 and 4 above before and after drug administration as per standard procedure. The port should then be locked using TauroLock Hep 100 when the patient is ready to leave.

Home

  1. Patients who are at home with Ports in situ should have these flushed and re-locked every 4 weeks by a Paediatric Oncology Outreach Nurse. Double chamber ports should have both chambers locked. This needs to be appropriately documented
  2. POON must obtain the appropriate drug Kardex prior to each home visit
  3. Take a discard of 2.5-5ml from the CVAD to remove any previous lock solution, each time it is accessed.
  4. Flush with 10 ml Sodium Chloride 0.9%, using standard percussive techniques, prior to port locking.
  5. The port should then be locked using TauroLock Hep 100

Management of Patients in other areas

All patients with lines locked with TauroLock or TauroLock Hep 100 should have their central venous access devices managed in accordance with this document.

 

5.4   Fungal Prophylaxis:

Antifungal prophylaxis should be primarily directed to patents in high risk groups - prolonged neutropenia (low white cell count) for more than 2 weeks, high dose steroid use, allogeneic stem cell transplants (particularly if complicated by graft-versus-host disease) and bone marrow failure syndromes. Haematology or oncology consultants should risk assess individual patients and balance the utility and safety of anti-fungal prophylaxis against the perceived risk of invasive mould disease. Further advice on specific patients should be discussed with microbiology. These discussions should be clearly documented in the case record.

Drug Choice

Antifungal prophylaxis is based on a strategy of Posaconazole as first line, and AmBisome (liposomal Amphotericin) as second line. Caspofungin (plus Fluconazole) should only be used as a third choice when neither Posaconazole or AmBisome are tolerated.

Posaconazole

  • Oral administration as tablets or liquid. Note that these are NOT equivalent, and the drug form must be stated clearly on the prescription
  • Pharmacy will advise on appropriate dosing
  • Requires therapeutic drug monitoring. First level 7-10 days after starting, then weekly after any dose change until target level is achieved
  • DRUG INTERACTION WITH VINCA ALKALOIDS. Azole antifungal drugs are predicted to increase exposure to Vinca alkaloids. All azole antifungals must be withheld for 48 hours before and after a dose of any Vinca alkaloid.

AmBisome (Liposomal Amphotericin

  • Intravenous use only
  • Prophylactic dose: 2mg/kg on Monday, Wednesday and Friday only
  • Drug of choice only when oral Posaconazole is not tolerated or contraindicated

Caspofungin

  • Intravenous use only
  • Discuss with patients’ consultant and/or microbiology before switching prophylactic antifungal to Caspofungin

 

High Risk Patient Groups

Haematology:

  • All stem cell transplant patients
  • All AML patients throughout treatment
  • All ALL patients during Induction (until Dexamethasone wean complete) and Delayed Intensification Part I (Day 2 until Day 22)
  • Bone Marrow Failure syndromes
  • Lymphoma patients treated on the Inter-Ritux guideline during chemotherapy and periods of profound neutropenia
  • Hodgkin’s Lymphoma patients during treatment with steroids

Oncology:

  • All High Risk Neuroblastoma patients
  • All autologous stem cell transplant patients
  • All ATRT patients
  • Any patient on steroids

Any patient with a previously confirmed fungal infection should be prescribed antifungal prophylaxis for the duration of treatment where there is a risk of neutropenia. On completion of treatment, a plan for de-escalation of anti-fungal treatment will be discussed with the patients’ consultant and microbiology.

Out-patient or day case patients should NOT receive fungal prophylaxis routinely unless they belong to the groups above.

The importance of ongoing surveillance and regular review of the clinical epidemiology of this vulnerable patient group is paramount. Regular review of these factors in conjunction with a consultant microbiologist taking account of environmental epidemiology is recommended, with subsequent review of prophylaxis if required.

Appendix 1: Lock volumes

TAUROLOCK

Line type

Lock volume

PIC (any manufacturer, any size)

1.0ml

 

 

Single Lumen Hickman

1.0ml

Double Lumen Hickman

1.0ml in each lumen

 

 

Single Chamber Port

1.5ml

Double Chamber Port

1.5ml in each chamber

 

TAUROLOCK HEP 100
**only when removing gripper needle**

Line type

Lock volume

Single Chamber Port

1.5ml

Double Chamber Port

1.5ml in each chamber

 

For any central CVAD in a patient <5Kg or under 6 months old, please check lock volumes with medical colleagues.

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Editorial Information

Last reviewed: 01 March 2020

Next review: 31 March 2021

Author(s): Dermot Murphy

Version: 1

Approved By: Schiehallion Clinical Governance Group

Document Id: RHC-HAEM-ONC-046