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 |
| |
| Authors: | Esteban Lopez-de-Sa Miriam Juarez Eduardo Armada José C. Sanchez-Salado Pedro L. Sanchez Pablo Loma-Osorio Alessandro Sionis Maria C. Monedero Manuel Martinez-Sellés Juán C. Martín-Benitez Albert Ariza Aitor Uribarri José M. Garcia-Acuña Patricia Villa Pablo J. Perez Christian Storm Anne Dee Jose L. Lopez-Sendon |
| |
| Affiliation: | 1.Acute Cardiac Care Unit, Cardiology Department,Hospital Universitario La Paz, IdiPaz. CIBERCV,Madrid,Spain;2.Cardiology Department,Hospital Universitario Gregorio Mara?ón. CIBERCV,Madrid,Spain;3.Cardiology Department,Hospital Universitario de Bellvitge,Barcelona,Spain;4.Cardiology Department,Hospital Universitario de Salamanca,Salamanca,Spain;5.Cardiology Department,Hospital Universitario Josep Trueta,Girona,Spain;6.Intensive Cardiac Care Unit, Cardiology Department,Hospital de Sant Pau. IIB-Sant Pau. CIBERCV, Universitat Autònoma de Barcelona,Barcelona,Spain;7.Universidad Complutense, Avenida Séneca 2, Universidad Europea,Madrid,Spain;8.Intensive Care Department,Hospital Clínico San Carlos,Madrid,Spain;9.Cardiology Department,Complejo Hospitalario Universitario de Santiago. CIBERCV,La Coru?a,Spain;10.Intensive Care Department,Hospital Universitario Principe de Asturias,Madrid,Spain;11.Cardiology Department,Hospital Universitario de Canarias,Santa Cruz de Tenerife,Spain;12.Department of Internal Medicine, Nephrology and Intensive Care,Charité-Universit?tsmedizin,Berlin,Germany;13.Biostatistics Department,ZOLL Medical Corporation,San Jose,USA |
| |
| Abstract: | 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 °C (n?=?52), 33 °C (n?=?49) or 34 °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 of?≤?3, blindly assessed at 90 days.ResultsAt baseline, different proportions of patients who had received defibrillation administered by a bystander were assigned to groups of 32 °C (13.5%), 33 °C (34.7%) and 34 °C (28.6%; p?=?0.03). The percentage of patients with an mRS?≤?3 at 90 days (primary endpoint) was 65.3, 65.9 and 65.9% in patients assigned to 32, 33 and 34 °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 90 days, 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 °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 °C. |
| |
| Keywords: | |
| 本文献已被 SpringerLink 等数据库收录！ |
|
