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JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
Continuous neuromuscular blockade infusion for out-of-hospital cardiac arrest patients treated with targeted temperature management: A multicenter randomized controlled trial.
PloS One 2018
INTRODUCTION: The aim of this trial was to investigate the effect of a continuous infusion of a neuromuscular blockade (NMB) in comatose out-of-hospital cardiac arrest (OHCA) subjects who underwent targeted temperature management (TTM).
METHODS: In this open-label, multicenter trial, subjects resuscitated from OHCA were randomly assigned to receive either NMB (38 subjects) or placebo (43 subjects) for 24 hours. Sedatives and analgesics were given according to the protocol of each hospital during TTM. The primary outcome was serum lactate levels at 24 hours after drug infusion. The secondary outcomes included in-hospital mortality, a poor neurological outcome at hospital discharge, changes in lactate levels, changes in the PaO2:FiO2 ratio over time and muscle weakness as assessed by the Medical Research Council (MRC) scale.
RESULTS: Eighty-one subjects (NMB group: median age, 65.5 years, 30 male patients; placebo group: median age, 61.0 years, 29 male patients) were enrolled in this trial. No difference in the serum lactate level at 24 hours was observed between the NMB (2.8 [1.2-4.0]) and placebo (3.6 [1.8-5.2]) groups (p = 0.238). In-hospital mortality and a poor neurologic outcome at discharge did not differ between the two groups. No significant difference in the PaO2:FiO2 ratio over time (p = 0.321) nor the MRC score (p = 0.474) was demonstrated.
CONCLUSIONS: In OHCA subjects who underwent TTM, a continuous infusion of NMB did not reduce lactate levels and did not improve survival or neurological outcome at hospital discharge. Our results indicated a limited potential for the routine use of NMB during early TTM. However, this trial may be underpowered to detect clinical differences, and future research should be conducted.
METHODS: In this open-label, multicenter trial, subjects resuscitated from OHCA were randomly assigned to receive either NMB (38 subjects) or placebo (43 subjects) for 24 hours. Sedatives and analgesics were given according to the protocol of each hospital during TTM. The primary outcome was serum lactate levels at 24 hours after drug infusion. The secondary outcomes included in-hospital mortality, a poor neurological outcome at hospital discharge, changes in lactate levels, changes in the PaO2:FiO2 ratio over time and muscle weakness as assessed by the Medical Research Council (MRC) scale.
RESULTS: Eighty-one subjects (NMB group: median age, 65.5 years, 30 male patients; placebo group: median age, 61.0 years, 29 male patients) were enrolled in this trial. No difference in the serum lactate level at 24 hours was observed between the NMB (2.8 [1.2-4.0]) and placebo (3.6 [1.8-5.2]) groups (p = 0.238). In-hospital mortality and a poor neurologic outcome at discharge did not differ between the two groups. No significant difference in the PaO2:FiO2 ratio over time (p = 0.321) nor the MRC score (p = 0.474) was demonstrated.
CONCLUSIONS: In OHCA subjects who underwent TTM, a continuous infusion of NMB did not reduce lactate levels and did not improve survival or neurological outcome at hospital discharge. Our results indicated a limited potential for the routine use of NMB during early TTM. However, this trial may be underpowered to detect clinical differences, and future research should be conducted.
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