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Clinical Content of the Guideline on the Use Drotrecogin Alfa

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					                                   Critical Care Directorate
            Guidelines on the use of Drotrecogin Alfa Activated (Xigris)



 Clinical Content of the Guideline on the Use Drotrecogin Alfa
                       Activated (XIGRIS)


Purpose:

To provide guidance on the administration and monitoring of drotrecogin alfa activated in
adults with severe sepsis admitted to ITU.


Scope:

The guideline applies to all Intensive Care specialist staff authorised to and involved in the
administration or monitoring of drotrecogin alfa activated to adults on ITU.


Criteria:


This form must be filed in the patient’s notes.


Consultant signature to authorise treatment __________________________


Patient details:




       Affix Patient Label




Date last reviewed: Nov 2005                           Date for next review: Nov 2007
Expiry Date: Nov 2007                                                      Page 1 of 6
                                   Critical Care Directorate
          Guidelines on the use of Drotrecogin Alfa Activated (Xigris)

Criteria for treatment with Drotrecogin Alfa:

Patient must be in ICU or HDU and able to benefit from treatment with drotrecogin.

Patient must have known or suspected infection as evidenced by 1 or more of the following:

Yes       No         Criteria
                     Syndrome associated with high risk of infection
                     Perforated viscus
                     Xray evidence of pneumonia plus purulent sputum
                     White blood cells in normally sterile body fluid


Patient must have 3 or more signs of systemic inflammation modified SIRS criteria

Yes       No         Criteria
                     Core temp of > or = 38 or < or = 36
                     Heart rate > or = 90beats/min
                     Resp rate > or = 20 breaths/minute, PaCO2 of < or = 32mm/Hg or
                     mechanical ventilation
                                            9                 9
                     WCC of > or = 12 x 10 /l or < or = 4x 10 /l or a differential count of >10%
                     immature neutrophils


And sepsis induced dysfunction of at least TWO organ systems for less than 48 hours

Yes       No         Criteria
                     CVS - Systolic BP < or = 90mmHg or MAP < or = 70mmHg or the need for
                     vasopressors for at least 1 hour despite adequate fluid loading
                     Renal - Urine output < 0.5ml/kg/hr despite adequate fluid loading
                     Respiratory - PaO2 to FiO2 ratio < or = 250 if other organs involved or <
                     or = 200 if sole organ dysfunction
                                                              9
                     Haematological - Platelet count <80x10 /l or decreased by 50% in
                     previous 3 days
                     Unexplained metabolic acidosis - pH < or = 7.3 or base deficit > or =
                     5mmol/l and plasma lactate > 1.5 x upper limit of normal.




Date last reviewed: Nov 2005                              Date for next review: Nov 2007
Expiry Date: Nov 2007                                                         Page 2 of 6
                                    Critical Care Directorate
          Guidelines on the use of Drotrecogin Alfa Activated (Xigris)

Contraindications and Cautions:

None of the following contra-indications can be present:

Yes       No         Criteria
                     Active internal bleeding
                     Recent (within 3 months) hemorrhagic stroke
                     Recent (within 2 months) intracranial or intraspinal surgery, or severe
                     head trauma
                     Trauma with an increased risk of life-threatening bleeding
                     Presence of an epidural catheter
                     Intracranial neoplasm or mass lesion or evidence of cerebral herniation
                     Patients with terminal conditions not expected to survive
                     Patients less than 18 years of age (due to limited experience)
                     <12 hours since surgical procedure or planned operation during infusion

If any of the following are present the potential risk of bleeding must be balanced against the
potential benefits of giving drotrecogin alfa.

Yes       No         Criteria
                                                  6
                     Platelet count <30,000 x 10 /L, even if the platelet count is increased after
                     transfusions
                     Prothrombin time-INR >3.0
                     Recent (within 6 weeks) gastrointestinal bleeding
                     Recent (within 3 months) ischaemic stroke
                     Concurrent unfractionated heparin > or = 15iu/kg/hr or full anticoagulant
                     dose low molecular weight heparin. (consider stopping heparin)
                     Intracranial arteriovenous malformation or aneurysm
                     Known bleeding diathesis
                     Chronic severe hepatic disease
                     Any other condition in which bleeding constitutes a significant hazard or
                     would be particularly difficult to manage because of its location
                     Recent administration (within 3 days) of thrombolytic therapy
                     Recent administration (within 7 days) of oral anticoagulants or
                     glycoprotein IIb/IIIa inhibitors
                     Recent administration (within 7 days) of aspirin or other platelet inhibitors
                     Pregnancy
                     HIV with CD4 count < or = 50
                     Patients with chronic renal failure on dialysis
Date last reviewed: Nov 2005                              Date for next review: Nov 2007
Expiry Date: Nov 2007                                                         Page 3 of 6
                                   Critical Care Directorate
          Guidelines on the use of Drotrecogin Alfa Activated (Xigris)
                     Patients who have had a liver, lung, bone marrow, pancreas or small
                     bowel transplant
                     Acute clinical pancreatitis without a proven source of infection
                     Any other condition in which the physician considers significant bleeding
                     is likely


Dose and Method of Administration

The dose is 24micrograms/kg/hr as a continuous intravenous infusion for a total duration of
96 hours.

The infusion should be given via a dedicated line/lumen or catheter.

No dose adjustments are required with respect to age, gender, renal or hepatic function.

If the infusion is interrupted for any reason, it must be restarted at the same rate
(24mcg/kg/hr) and continued to complete the recommended 96 hours of dosing.

The Drotrecogin is available in 5mg and 20mg vials. The vials must be reconstituted with
water for injection and then further diluted to the recommended strength with 0.9% Sodium
Chloride. The Vials are stable for up to 3 hours when reconstituted, and the solution once
made up is stable for 14 hours, at room temperature.

Avoid inverting or shaking the product at any stage in preparation as agitation causes
degradation of the drug.


Management of Invasive Procedures During Drotrecogin Alfa Infusion

•   Discontinue Drotrecogin alfa 2 hours prior to performing an invasive surgical procedure or
    procedures with an inherent risk of bleeding.

•   Initiation of Drotrecogin alfa once haemostasis has been achieved:
         - Reconsider 12 hours after major invasive procedures or surgery.
         - May restart immediately after uncomplicated, less invasive procedures.

•   Immediately stop administration of Drotrecogin alfa should clinically important bleeding
    occur.




Date last reviewed: Nov 2005                              Date for next review: Nov 2007
Expiry Date: Nov 2007                                                         Page 4 of 6
                                     Critical Care Directorate
          Guidelines on the use of Drotrecogin Alfa Activated (Xigris)
Monitoring

Start of Infusion (time/date):

Infusion discontinued (time/date):

If discontinued after less than 96h give reason(s):




Record daily platelet count and clotting profile. If measures of coagulopathy worsen while the
infusion is running consideration must be made to stopping the infusion.

Drotrecogin may affect the APTT in a variable way depending on the assay used.

                    Day 1            Day 2         Day 3              Day 4             Day 5
Platelet count
APTT
INR

Record complications related to drotrecogin infusion (e.g. bleeding):




References

•   The Efficacy and Safety of Recombinant Human Activated Protein C for Severe Sepsis.
    PROWESS (Protein C worldwide evaluation of severe sepsis). Bernard GR et al. NEJM,
                               th
    Vol 344, No.10, March 8 , 2001.

•   Summary of Product Characteristics Xigris. EMC Cited September 2005.
    www.emc.medicines.org.uk

•   NICE Technology Appraisal 84 – Drotrecogin Alfa (Activated) For Severe Sepsis.
    September 2004. Cited October 2005. www.nice.org.uk

Date last reviewed: Nov 2005                               Date for next review: Nov 2007
Expiry Date: Nov 2007                                                          Page 5 of 6
                                     Critical Care Directorate
          Guidelines on the use of Drotrecogin Alfa Activated (Xigris)

  Managerial Content of the Guideline on the Use Drotrecogin
                  Alfa Activated (XIGRIS)

Preparation / Review
                Name                              Position                    Date
Prepared by:    Dr J P Little                     Consultant in ICU and       April 2004
                                                  Anaesthesia
Updated by:          Louise Jones                 Critical Care               Nov 2005
                                                  Pharmacist
Reviewed by:         Dr J P Little                Consultant in ICU and       Nov 2005
                                                  Anaesthesia
                     Jenny Jones                  Medicine Management         Nov 2005
                                                  Pharmacist

Authorisation
Clinical Director / Lead Clinician   April 2004
Director of Nursing and              XXXX
Operations
Chief Pharmacist                     XXXX
Approved by Drug and                 May 2004
Therapeutics Committee               Update approved Feb 2006.

THE EXPIRY DATE OF THIS DOCUMENT IS Nov 2007 AFTER THIS DATE THE
PROTOCOL WILL NOT BE VALID EXCEPT AS IN THE FOLLOWING PARAGRAPH.

If continued use is appropriate, the guideline must be submitted to the Chairman of the
Drug and Therapeutics Committee for approval by that committee. The protocol will
remain valid only until the next available meeting of the Drug and Therapeutics
Committee following the expiry date at which a decision will be made regarding its
future use.

All protocols will be subject to review after two years, or earlier if clinical practice
changes warrant it.

THIS DOCUMENT MUST NOT BE ALTERED OR AMENDED IN ANYWAY WITHOUT THE
EXPRESS PERMISSION OF THE PHARMACY DEPARTMENT WHO HOLD a COPY OF
THE MOST RECENT VERSION. PLEASE CONTACT THE PHARMACY DEPARTMENT
SHOULD ANY QUERIES ARISE.



Date last reviewed: Nov 2005                                 Date for next review: Nov 2007
Expiry Date: Nov 2007                                                            Page 6 of 6

				
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