A multicentre randomized pilot trial on the effectiveness of different levels of cooling in comatose survivors of out-of-hospital cardiac arrest: the FROST-I trial
Por:
Lopez-de-Sa, E, Juarez, M, Armada, E, Sanchez-Salado, JC, Sanchez, PL, Loma-Osorio, P, Sionis, A, Monedero, MC, Martinez-Selles, M, Martin-Benitez, JC, Ariza, A, Uribarri, A, Garcia-Acuna, JM, Villa, P, Perez, PJ, Storm, C, Dee, A, Lopez-Sendon, JL
Publicada:
1 nov 2018
Resumen:
PurposeTo obtain initial data on the effect of different levels of targeted temperature management (TTM) in out-of-hospital cardiac arrest (OHCA).MethodsWe designed a multicentre pilot trial with 1:1:1 randomization to either 32 degrees C (n=52), 33 degrees C (n=49) or 34 degrees C (n=49), via endovascular cooling devices during a 24-h period in comatose survivors of witnessed OHCA and initial shockable rhythm. The primary endpoint was the percentage of subjects surviving with good neurologic outcome defined by a modified Rankin Scale (mRS) score of3, blindly assessed at 90days.ResultsAt baseline, different proportions of patients who had received defibrillation administered by a bystander were assigned to groups of 32 degrees C (13.5%), 33 degrees C (34.7%) and 34 degrees C (28.6%; p=0.03). The percentage of patients with an mRS3 at 90days (primary endpoint) was 65.3, 65.9 and 65.9% in patients assigned to 32, 33 and 34 degrees C, respectively, non-significant (NS). The multivariate Cox proportional hazards model identified two variables significantly related to the primary outcome: male gender and defibrillation by a bystander. Among the 43 patients who died before 90days, 28 died following withdrawal of life-sustaining therapy, as follows: 7/16 (43.8%), 10/13 (76.9%) and 11/14 (78.6%) of patients assigned to 32, 33 and 34 degrees C, respectively (trend test p=0.04). All levels of cooling were well tolerated.ConclusionsThere were no statistically significant differences in neurological outcomes among the different levels of TTM. However, future research should explore the efficacy of TTM at 32 degrees C.Clinical trial registrationClinicalTrials.gov unique identifier: NCT02035839 (http://clinicaltrials.gov).
Filiaciones:
Lopez-de-Sa, E:
Hosp Univ La Paz, Cardiol Dept, Acute Cardiac Care Unit, IdiPaz,CIBERCV, Paseo Castellana 261, Madrid 28046, Spain
Juarez, M:
Hosp Univ Gregorio Maranon, Cardiol Dept, CIBERCV, Calle Dr Esquerdo 46, Madrid 28007, Spain
Armada, E:
Hosp Univ La Paz, Cardiol Dept, Acute Cardiac Care Unit, IdiPaz,CIBERCV, Paseo Castellana 261, Madrid 28046, Spain
Sanchez-Salado, JC:
Hosp Univ Bellvitge, Cardiol Dept, Carrer Princeps Espanya S-N, Lhospitalet De Llobregat 08902, Spain
Sanchez, PL:
Hosp Univ Salamanca, Cardiol Dept, Paseo San Vicente 58-182, Salamanca 37007, Spain
Loma-Osorio, P:
Hosp Univ Josep Trueta, Cardiol Dept, Ave Franca S-N, Girona 17007, Spain
Sionis, A:
Univ Autonoma Barcelona, Cardiol Dept, Intens Cardiac Care Unit, Hosp St Pau,IIB St Pau,CIBERCV, Calle San Quintin 89, Barcelona 08026, Spain
Monedero, MC:
Hosp Univ La Paz, Cardiol Dept, Acute Cardiac Care Unit, IdiPaz,CIBERCV, Paseo Castellana 261, Madrid 28046, Spain
Martinez-Selles, M:
Hosp Univ Gregorio Maranon, Cardiol Dept, CIBERCV, Calle Dr Esquerdo 46, Madrid 28007, Spain
Univ Complutense, Univ Europea, Ave Seneca 2,Calle Tajo S-N, Madrid 28670, Spain
Martin-Benitez, JC:
Hosp Clin San Carlos, Intens Care Dept, Calle Prof Martin Lagos 2, Madrid 28040, Spain
Ariza, A:
Hosp Univ Bellvitge, Cardiol Dept, Carrer Princeps Espanya S-N, Lhospitalet De Llobregat 08902, Spain
Uribarri, A:
Hosp Univ Salamanca, Cardiol Dept, Paseo San Vicente 58-182, Salamanca 37007, Spain
Garcia-Acuna, JM:
Complejo Hosp Univ Santiago, Cardiol Dept, CIBERCV, Travesia Choupana S-N, La Coruna 15706, Spain
Villa, P:
Hosp Univ Principe Asturias, Intens Care Dept, Carretera Alcala Meco S-N, Madrid 28805, Spain
Perez, PJ:
Hosp Univ Canarias, Cardiol Dept, Calle Ofra S-N, San Cristobal De Laguna 38320, Santa Cruz De T, Spain
Storm, C:
Charite, Dept Internal Med Nephrol & Intens Care, Charitepl 1, D-10117 Berlin, Germany
Dee, A:
ZOLL Med Corp, Biostat Dept, 2000 Ringwood Ave, San Jose, CA 95131 USA
Lopez-Sendon, JL:
Hosp Univ La Paz, Cardiol Dept, Acute Cardiac Care Unit, IdiPaz,CIBERCV, Paseo Castellana 261, Madrid 28046, Spain
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