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The design of the P...
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Dillenbeck, EmelieKarolinska Inst, Sweden; Karolinska Inst, Sweden
(author)
The design of the PRINCESS 2 trial: A randomized trial to study the impact of ultrafast hypothermia on complete neurologic recovery after out-of-hospital cardiac arrest with initial shockable
- Article/chapterEnglish2024
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MOSBY-ELSEVIER,2024
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LIBRIS-ID:oai:DiVA.org:liu-203436
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https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-203436URI
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https://doi.org/10.1016/j.ahj.2024.02.020DOI
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http://kipublications.ki.se/Default.aspx?queryparsed=id:238417773URI
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Language:English
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Summary in:English
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
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Funding Agencies|Region Stockholm [520403]; Swedish Heart and Lung Foundation [20220688]
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Background Delayed hypothermia, initiated after hospital arrival, several hours after cardiac arrest with 8-10 hours to reach the target temperature, is likely to have limited impact on overall survival. However, the effect of ultrafast hypothermia, i.e., delivered intra-arrest or immediately after return of spontaneous circulation (ROSC), on functional neurologic outcome after out -of -hospital cardiac arrest (OHCA) is unclear. In two prior trials, prehospital trans -nasal evaporative intra-arrest cooling was safe, feasible and reduced time to target temperature compared to delayed cooling. Both studies showed trends towards improved neurologic recovery in patients with shockable rhythms. The aim of the PRINCESS2-study is to assess whether cooling, initiated either intra-arrest or immediately after ROSC, followed by in -hospital hypothermia, significantly increases survival with complete neurologic recovery as compared to standard normothermia care, in OHCA patients with shockable rhythms. Methods/design In this investigator -initiated, randomized, controlled trial, the emergency medical services (EMS) will randomize patients at the scene of cardiac arrest to either trans -nasal cooling within 20 minutes from EMS arrival with subsequent hypothermia at 33 degrees C for 24 hours after hospital admission (intervention), or to standard of care with no prehospital or in -hospital cooling (control). Fever ( > 37,7 degrees C) will be avoided for the first 72 hours in both groups. All patients will receive post resuscitation care and withdrawal of life support procedures according to current guidelines. Primary outcome is survival with complete neurologic recovery at 90 days, defined as modified Rankin scale (mRS) 0-1. Key secondary outcomes include survival to hospital discharge, survival at 90 days and mRS 0-3 at 90 days. In total, 1022 patients are required to detect an absolute difference of 9% (from 45 to 54%) in survival with neurologic recovery (80% power and one-sided alpha= 0,025, beta = 0,2) and assuming 2,5% lost to follow-up. Recruitment starts in Q1 2024 and we expect maximum enrolment to be achieved during Q4 2024 at 20-25 European and US sites. Discussion This trial will assess the impact of ultrafast hypothermia applied on the scene of cardiac arrest, as compared to normothermia, on 90 -day survival with complete neurologic recover y in OHCA patients with initial shockable rhythm. Trial registration NCT06025123. (Am Heart J 2024;271:97-108.)
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Hollenberg, JacobKarolinska Institutet,Karolinska Inst, Sweden
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Holzer, MichaelMed Univ Vienna, Austria
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Busch, Hans-JoergUniv Freiburg, Germany
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Nichol, GrahamUniv Washington, WA USA
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Radsel, PeterUniv Med Ctr, Slovenia
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Belohlavec, JanCharles Univ Prague, Czech Republic; Gen Univ Hosp, Czech Republic
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Torres, Ervigio CorralSAMUR Protecc Civil, Spain
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Lopez-de-Sa, EstebanCARDIO ELA, Spain
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Rosell, FernandoCtr Invest Biomed Invest Biomed Rioja CIBIR, Spain
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Ristagno, GiuseppeUniv Milan, Italy
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Forsberg, SuneKarolinska Institutet,Karolinska Inst, Sweden
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Annoni, FilippoUniv Libre Bruxelles, Belgium
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Svensson, LeifKarolinska Inst, Sweden
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Jonsson, MartinKarolinska Institutet,Karolinska Inst, Sweden
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Bäckström, Denise,1976-Linköpings universitet,Avdelningen för kirurgi, ortopedi och onkologi,Medicinska fakulteten,Region Östergötland, Anestesi- och intensivvårdskliniken VIN(Swepub:liu)denba90
(author)
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Gellerfors, MikaelKarolinska Institutet,Capio, Sweden; Karolinska Univ Hosp, Sweden; Karolinska Inst, Sweden
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Awad, AkilKarolinska Inst, Sweden
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Taccone, Fabio S.Univ Libre Bruxelles, Belgium
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Nordberg, PerKarolinska Institutet,Karolinska Inst, Sweden
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Karolinska InstitutetKarolinska Inst, Sweden; Karolinska Inst, Sweden
(creator_code:org_t)
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In:American Heart Journal: MOSBY-ELSEVIER271, s. 97-1080002-87031097-6744
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Annoni, Filippo
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