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RESUSCITATION OUTCOMES CONSORTIUM ROC ALPS Amiodarone, Lidocaine, or Placebo Study Version 24: Rev. 2012-4-24.

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Presentation on theme: "RESUSCITATION OUTCOMES CONSORTIUM ROC ALPS Amiodarone, Lidocaine, or Placebo Study Version 24: Rev. 2012-4-24."— Presentation transcript:

1 RESUSCITATION OUTCOMES CONSORTIUM ROC ALPS Amiodarone, Lidocaine, or Placebo Study Version 24: Rev

2 Understand the rationale for antiarrhythmic use in out-of-hospital cardiac arrest Understand how to carry out the ROC ALPS study protocol Learning Objectives v24 NOTE: IN ALPS, unless otherwise noted, the abbreviation “VF/VT” refers to ventricular fibrillation or pulseless ventricular tachycardia.

3 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 Reason for the Study v24

4 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 Prior Amiodarone Studies *No significant difference v24

5 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 New Formulation of Amiodarone v24

6 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) Benefit of Antiarrhythmics Unclear v24

7 Trial Design * In ALPS, ‘VF/VT’ refers to ventricular fibrillation or pulseless ventricular tachycardia v24

8 Non-traumatic out-of-hospital cardiac arrest Vascular access (IV or IO) Persistent/recurrent VF/VT after 1 (or more) shocks… (“it’s baaack!”) Inclusion Criteria YES: Open label IV amiodarone or lidocaine use in-field 1 Known hypersensitivity or allergy to amiodarone or lidocaine Protected population (prisoners, children 2, pregnancy, etc.) NO: 1 This also excludes use of IO lidocaine to minimize pain when inserting/flushing IO line 2 Under local age of consent v24

9 What counts as a “shock”?  ROC-EMS agency administered shock(s) » First responder or BLS-AED delivered a shock » ALS delivered a shock  PAD and non-ROC agency shock(s)  Not ICD shock(s) Inclusion continued… v24

10 What is persistent/recurrent VF/VT?  Confirmed VF/pulseless VT (operationally, pulseless means needing CPR) seen anytime after first shock » VF/VT seen (see-through CPR in systems that “look” at the rhythm after a shock before drug treatment ) after ≥1 shock » VF/VT seen on second or later rhythm analysis (in systems that perform a formal rhythm analysis before each shock or drug intervention, or those who give drugs “blindly” (during CPR) following a shock) after ≥1 shock  If thinking antiarrhythmic drug for VF/pulseless VT… give ALPS drug Inclusion continued… It’s baaack! v24

11 Drug Kit Design Three (3) identical (blinded) syringes SYRINGE #AMIODARONE KITLIDOCAINE KITPLACEBO KIT 1AAmiodarone 150 mg (3 cc)Lidocaine 60 mg (3 cc)Placebo (3 cc) 1BAmiodarone 150 mg (3 cc)Lidocaine 60 mg (3 cc)Placebo (3 cc) 2Amiodarone 150 mg (3 cc)Lidocaine 60 mg (3 cc)Placebo (3 cc) v24

12 Drug Kit Design Drug Kit Design continued… Length: 7.75 in. Width: 4.5 in. Height: 1.75 in v24

13 Adapter must be used to ensure compatibility with all IV infusion sets ClearLink Adapter Kits are packaged with a Baxter CLEARLINK Adapter v24

14 Six minute video reviewing background for CLEARLINK requirement, method of use, and reporting potential adverse events ClearLink Adapter View supplemental ALPS training video, “ Mandatory use of CLEARLINK Adapters with ALPS Syringes” dated Posted on ROC-web: https://roc.uwctc.org/tiki/alps-training-materials https://roc.uwctc.org/tiki/alps-training-materials Available for download: Windows Media or QuickTime formats v24

15 Cardiac Arrest—VF/pulseless VT After Shock #1 (or more)  NSR/ROSC/Asystole/PEA?→ Move on  Still in VF/ VT?→ Give Syringes #1A and #1B After Subsequent shock(s)  NSR/ROSC/Asystole/PEA?→ Move on  Still in VF/ VT?→ Give Syringe #2 Move on Study Protocol v24

16 “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 What if VF/VT Returns? v24

17 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 What about late-occurring VF/VT? v24

18 Shock→ immediate CPR (without look) Give study drug during 2-minute period of CPR after shock, in the belief that VF/ VT is still present  The rationale for this approach is that re-fibrillation during this 2-minute period is likely, even if the shock was initially successful. Shock at next scheduled pause A) My EMS agency does not “stop to look” after giving a shock VF/pulseless VT seen on second or later rhythm analysis after ≥1 shock… v24

19 Shock→ immediate CPR Brief (5-second max) pause at approximately 1 minute into CPR for rhythm check/confirmation 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 B) My EMS agency stops to look (peek) after giving a shock, or uses "see-thru" technology v24

20 After 2 minutes of CPR, as compressors are switched, quickly look at the rhythm If VF/VT seen, resume CPR and charge monitor  Give ALPS drug while charging→ then shock  If not possible to give drug before shock, give it immediately afterward, as CPR is resumed If no VF/VT or unable to determine, resume CPR and await next scheduled rhythm analysis C) My EMS agency stops to look (peek) when changing compressors at 2 minutes after a shock v24

21 Analyze rhythm at customary end of 2-minute CPR period (maximum 5 seconds) If VF/ VT → start next 2-minute CPR period, give ALPS drug and charge defibrillator Shock at next scheduled pause If no VF/VT → resume CPR (or check pulse if organized rhythm seen) and treat per local protocol If unable to determine rhythm, resume CPR and await next scheduled rhythm analysis D) My EMS agency performs a formal rhythm analysis before each drug or shock intervention v24

22 Yes Give epinephrine or vasopressin ASAP per local protocol  If participating in CCC study, give within 5 minutes of arrival of ALS-capable EMS provider ALPS drug does not cause hypotension; does not require concurrent vasopressor If vasopressor not already just given, may administer epinephrine/vasopressin and first dose of ALPS drug back-to-back,* in order to expedite getting ALPS drug on board sooner Should I give epinephrine or vasopressin? *After flushing between drugs v24

23 Two syringes First Dose = Syringe #1A and Syringe #1B Second Dose = Syringe #2 Exception = Small persons Is the first dose of the study drug two syringes or one? v24

24 Change from standard protocol First Dose = Syringe #1A only Second Dose = Syringe #1B only Do not use Syringe #2 What if the patient is small? (<100 lbs/45 kg) v24

25 Non-function of ALPS syringe Anaphylaxis (severe allergic reaction) Pacing started in field Seizures, shivering, myoclonus Complications of IV or IO administration after ALPS given For any ALPS patient, what potential adverse events must be reported to ROC? v24

26 May use other antiarrhythmics available to the agency (e.g., magnesium, beta blockers and/or procainamide) Additional shock(s) NO open label amiodarone or lidocaine in field permitted before or after ALPS drug* What if VF/VT persists (or recurs) after I give all the study drug? Further management at discretion of providers… *Also excludes use of IO lidocaine to minimize pain when inserting/flushing IO line v24

27 No known value of prophylactic antiarrhythmic drug infusions after cardiac arrest Since no open label amiodarone or lidocaine can be given in the field, no infusions of these drugs should be given by EMS providers (includes no IO administration of lidocaine given to minimize pain when inserting or flushing IO line) Duration of drug effect (“half-life”) should last until ED arrival Use of open label lidocaine or amiodarone is permitted in hospital Should I start an infusion after achieving ROSC? v24

28 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. Drugs can make it worse! Transport to hospital for definitive diagnosis/care If in doubt, consider synchronized electrical cardioversion What to do about wide complex tachycardia with pulse/BP? v24

29 If any syringe in the kit is broken upon opening, or does not function prior to giving…  Stop ALPS, shut the box, and move on  Use open label lidocaine or amiodarone, if needed  Usual drug doses If any portion of any ALPS syringe has already been given and syringe breaks or does not function…  Stop ALPS, shut the box, and move on  Use open label lidocaine or amiodarone, if needed  Limit lidocaine to ≤ 200 mg total dose  May use amiodarone at usual doses What if one or more syringes are broken or do not function? v24

30 Quarantine ALPS kit with the damaged syringe Document circumstances  On patient record  ROC-report form Promptly notify ROC coordinator Return ALPS kit with syringes to ROC coordinator What must be reported when any ALPS syringe is broken or does not function? v24

31 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 What should the Emergency Department do? v24

32 The ED script will include  ROC physician name and phone number for the ED physician to contact for more information or questions  Contact information for rare request to un-blind study drug Defer questions to local ROC staff The Emergency Department really wants to know what drug we gave? v24

33 Drug Kit Peel-off Barcode labels PCR Affix to… Hospital Notification Sheet v24

34 When feasible, this written script will be presented to the LAR by the prehospital provider. The acute circumstances of cardiac arrest may rarely, if ever, afford such opportunity on-scene without compromising patient care. Accordingly, determining if or when presenting this script on-scene is feasible …will be left to clinical discretion of the provider. FDA Directive v24

35 Yes, both protocols can be done at the same time. Do I carry out ALPS and CCC at the same time? CCCALPS v24

36 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 vasopressor 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 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… *After flushing between drugs v24

37 Document when ALPS drug given  Time-stamp each dose of ALPS drug  Document shock number that follows each dose of ALPS drug Inform ED/Notify ROC of ALPS use Five Take-to-the-Street Principles of ALPS continued… v24

38 Questions?


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