Download ROC ALPS

ROC ALPS
Amiodarone, Lidocaine, or Placebo Study
ROC - ALPS
Learning Objectives
• Understand the rationale for antiarrhythmic use in
out-of-hospital cardiac arrest
• Understand how to carry out the ROC ALPS study
protocol
ROC - ALPS
Reason for the Study
• About 24% of cardiac arrests are due to VF/VT*
• 70% will re-fibrillate after the first shock
• Antiarrhythmic drugs (good or bad?):
–
–
–
–
–
Unlikely to chemically convert patients out of VF/VT
May increase probability of shock success
May prevent VT/VF recurrence after defibrillation
May result in higher incidence of bradycardia/asystole
May improve, not change, or worsen patient outcome
• Current options:
– Lidocaine
– Amiodarone
* In
ALPS, the abbreviation “VF/VT” is defined to mean VF or pulseless VT
ROC - ALPS
Prior Amiodarone Studies
• Seattle/King County medics (ARREST)
– Amiodarone vs. placebo
– Amiodarone improved admission alive to hospital→ NSD* in survival to
discharge
• Toronto medics (ALIVE)
– Amiodarone vs. lidocaine
– Amiodarone improved admission alive to hospital→ NSD* in survival to
discharge
• Oslo medics
– IV/drugs vs. no IV
– IV/drugs improved admission alive to hospital → NSD* in survival to discharge
• All trials underpowered to address survival
*No significant difference
ROC - ALPS
New Formulation of Amiodarone
• Amiodarone previously diluted in Polysorbate 80
(“Tween”) as Cordarone® & now generic formulations
– Caused hypotension
– Foaming issues
– Adherent to plastic—requires all-glass packaging
• New formulation: Nexterone® (PM101)
–
–
–
–
–
Amiodarone diluted in Captisol
Does not cause hypotension
Safe for bolus administration
Plastic-friendly—allows for prefilled non-glass syringes in future
Currently FDA-approved only in glass syringe
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Benefit of Antiarrhythmics Unclear
•
American Heart Association 2010 ACLS Guidelines
– Amiodarone or lidocaine (each is a class IIb weak “may be
considered” recommendation for shock-refractory VF/VT)
•
Amiodarone and lidocaine may have other adverse effects
•
Neither drug ever proven to improve survival
•
Unproven therapies may be . . .
– Beneficial
– Inconsequential (make no difference)
– Harmful
•
The only way to know if lidocaine or amiodarone “work” is to compare either
against neither (placebo)
ROC - ALPS
Trial Design
Population
Persistent or
recurrent VF/VT*
after >1 shock
Vascular Access
Intervention
Amiodarone
Outcome
* In
RANDOMIZE
Lidocaine
Neither
(saline placebo)
SURVIVAL TO
HOSPITAL DISCHARGE
ALPS, the abbreviation “VF/VT” refers to ventricular fibrillation or pulseless v-tach.
ROC - ALPS
Inclusion Criteria
YES:
• ≥ 18 years
• Non-traumatic out-of-hospital cardiac arrest ( hanging and
electrocutions can be included unless severe trauma is involved)
• Vascular access
• Persistent/recurrent VF/VT after 1 (or more) shocks…
(“it’s baaack!”)
NO:
• Open label IV amiodarone or lidocaine use in-field1
• Known hypersensitivity or allergy to amiodarone or lidocaine
• Protected population (prisoners, children2 pregnancy, etc.)
ROC - ALPS
Inclusion continued…
• What counts as a “shock”?
– ROC-EMS agency administered shock(s)
• First responder or BLS-AED delivered a shock
• ALS delivered a shock
– PAD/non-ROC agency shock(s)
– Not ICD shock(s)
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Inclusion continued…
It’s
baaack!
• What is persistent/recurrent VF/VT?
– Confirmed VF/pulseless VT seen anytime after first shock
• VF/VT seen via see-through CPR and “VF, VT detected prompt” after
≥ 1 shock. MUST STOP CPR to confirm VF or VT (5 seconds max)
ROC - ALPS
Inclusion continued…
• Note!
• If patient was shocked ≥ 1 times prior to your arrival by any person
and you can establish an IV during the 2 minutes immediately
following the last shock, you can administer Epinephrine and ALPS
drugs if the patient is in VF/VT as noted in the see thru tracing (stop
for 5 seconds to confirm)
• If the patient was shocked ≥ 1 times prior to your arrival and upon
your arrival is in a non-shockable rhythm, you cannot give ALPS until
you see recurrence of VF or VT during the arrest.
ROC - ALPS
Drug Kit Design
Three (3) identical (blinded) syringes
SYRINGE #
AMIODARONE KIT
LIDOCAINE KIT
PLACEBO KIT
1A
Amiodarone 150 mg (3 cc)
Lidocaine 60 mg (3 cc)
Placebo (3 cc)
1B
Amiodarone 150 mg (3 cc)
Lidocaine 60 mg (3 cc)
Placebo (3 cc)
2
Amiodarone 150 mg (3 cc)
Lidocaine 60 mg (3 cc)
Placebo (3 cc)
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Drug Kit Design continued…
Length: 7.75 in.
Width: 4.5 in.
Height: 1.75 in.
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ClearLink Adapter
• Kits will be packaged with a Baxter
ClearLink Adapter
• Adapter must be
used to ensure
compatibility with all
IV infusion sets
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Tracking of Kit
• Paramedic Daily Responsibility
– Document on the Narcotic tracking sheet daily stock
– Document usage on the Narcotic tracking sheet
• Count
• Breakage
• Run#
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Restocking of ALPS Kit
• Contact Supervisor post call and request
replacement kit
– Record usage on Narcotic tracking sheet (run #) and new
tracking number for the new kit (similar to the restocking
of controlled drugs).
ROC - ALPS
Study Protocol
• Cardiac Arrest—VF/pulseless VT
• After Shock #1 (or more)
– NSR/ROSC/Asystole/PEA?→ Move on
– Still in VF/pulseless VT?→ Give Syringes #1A and #1B
• After Subsequent shock(s)
– NSR/ROSC/Asystole/PEA?→ Move on
– Still in VF/pulseless VT?→ Give Syringe #2
• Move on
ROC - ALPS
What if VF/VT Returns?
• “It’s baaaack…”
– Carry out the full ALPS Protocol
• What if I gave Syringes #1A and #1B, got pulses
(ROSC) back, but VF/pulseless VT later returns?
– Shock again
– If this shock fails to stop VF/VT, give Syringe #2
ROC - ALPS
What about late-occurring VF/VT?
• VF/pulseless VT is treated the same way anytime it
recurs after 1 or more prior shocks. This applies to:
– VF/VT on EMS arrival
– VF/VT arrest after EMS arrival
– Late-occurring VF/VT
• Anytime VF/pulseless VT returns after 1 or more
prior shocks (“it’s baaack”)→ give ALPS drug ASAP
ROC - ALPS
"see-thru" technology
• Shock→ immediate CPR
• Brief (5-second max) pause in CPR to check rhythm if
prompted by “VF/VT detected” and an IV is in place and
it is an appropriate time for ALPS.
• If VF/VT, resume CPR and give ALPS drug
• Shock at next scheduled pause
• If no VF/VT or unable to determine, resume CPR and
await next scheduled rhythm analysis
ROC - ALPS
Should I give epinephrine?
• Yes.
• Give epinephrine or vasopressin ASAP per local protocol
– If participating in CCC study, give within 10 minutes of arrival of ALScapable EMS provider
• ALPS drug does not cause hypotension; does not require concurrent
vasopressor
• If vasopressor not already just given, may administer epinephrine and first
dose of ALPS drug back-to-back,* in order to expedite getting ALPS drug
on board sooner
*After flushing between drugs.
ROC - ALPS
Is the first dose of the study drug two syringes or one?
• Two syringes
• First Dose = Syringe #1A and Syringe #1B
• Second Dose = Syringe #2
• Exception = Small persons
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What if the patient is small? (<100 lbs/45 kg)
• Change from standard protocol
• First Dose = Syringe #1A only
• Second Dose = Syringe #1B only
• Do not use Syringe #2
ROC - ALPS
What if VF/VT persists (or recurs) after I give all the
study drug?
Further management at discretion of providers…
• May use other antiarrhythmics if you receive an
order from the BHP
• NO open label amiodarone or lidocaine in field
permitted before or after ALPS drug (no ALPS if
antiarrhythmic was given prior to the arrest – follow standard
treatment of cardiac arrest)
ROC - ALPS
What to do about wide complex tachycardia with
pulse/BP?
• ALPS is strictly for shock-resistant VF/pulseless VT needing
CPR. This applies to all doses of ALPS drug.
• If the rhythm doesn’t need CPR it shouldn’t get ALPS
• A perfusing wide complex tachycardia can be a
supraventricular rhythm with BBB and not need further
treatment. (patch for orders/consult if rhythm is suggestive
of VT)
• Transport to hospital for definitive diagnosis/care
• If in doubt, consider electrical cardioversion (patch required)
ROC - ALPS
What if one or more syringes is broken, or gets broken
before/while being given?
• If any syringe in the kit is broken upon opening…
 Patient excluded from study (DC ALPS)
 Open label lidocaine or amiodarone, if needed
 Usual drug doses
• If at least 1 ALPS syringe has already been given…
 Patient excluded from study (DC ALPS)
 Open label lidocaine or amiodarone, if needed
 Limit lidocaine to ≤ 200 mg (total dose)
 May use amiodarone at usual doses
ROC - ALPS
What should the Emergency Department do?
• Notify ED that the patient may have received
amiodarone or lidocaine or neither in the field
• Written script left with ED
• The script will indicate the drugs/doses the patient may
have received in the field
– Limit lidocaine to an additional 100–120 mg over the next 2
hours in ED
– No restriction on additional amiodarone in ED
– All other ED treatments may be given as required
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The Emergency Department really wants to
know what drug we gave?
• The ED script will include a ROC physician name and phone
number for the ED physician to contact for more information
or questions
• Defer such questions to local ROC staff
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Study Kit Labels
Drug Kit
• Peel-off Barcode labels
Affix to…
Hospital Notification Sheet
Document the
randomization # on
EPCR
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Do I carry out ALPS and CCC
at the same time?
• Yes, both protocols can be done at the same time.
CCC
ALPS
ROC - ALPS
Five Take-to-the-Street Principles of ALPS
Think of the ALPS drug as you would about any
antiarrhythmic for VF/pulseless VT and use it accordingly…
•
Prioritize vascular access
•
Expedite ALPS drug for shock-resistant VF/VT rhythms requiring CPR
– VF/pulseless VT that persists/recurs after ≥1 shocks (“It’s baaack!”)
– OK to give Epinephrine plus ALPS back-to-back to speed treatment*
– Give ALPS drug ASAP from when recurrent VF/VT last seen (≤2 minutes)
•
Judge patient’s size
– Normal: 2 syringes→ 1 syringe rescue
– Small (<100 lbs/45 kg): 1 syringe→ 1 syringe rescue
*After flushing between drugs
ROC - ALPS
Five Take-to-the-Street Principles of ALPS continued…
• Document when ALPS drug given
– Time-stamp each dose of ALPS drug
– Document shock number that follows each dose of ALPS
drug
• Inform ED that ALPS drugs were given and provide them
with the hospital notification sheet.
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REMEMBER!
You must stop CPR to perform a rhythm
analysis (5 seconds max)
See-thru-CPR cannot be used to analyze a
rhythm while CPR is ongoing
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Questions?