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Browsing by Subject "Induced hypothermia"
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Item Association Between Increased Seizures During Rewarming After Hypothermia for Neonatal Hypoxic Ischemic Encephalopathy and Abnormal Neurodevelopmental Outcomes at 2-Year Follow-up: A Nested Multisite Cohort Study(American Medical Association, 2021) Chalak, Lina F.; Pappas, Athina; Tan, Sylvia; Das, Abhik; Sánchez, Pablo J.; Laptook, Abbot R.; Van Meurs, Krisa P.; Shankaran, Seetha; Bell, Edward F.; Davis, Alexis S.; Heyne, Roy J.; Pedroza, Claudia; Poindexter, Brenda B.; Schibler, Kurt; Tyson, Jon E.; Ball, M. Bethany; Bara, Rebecca; Grisby, Cathy; Sokol, Gregory M.; D'Angio, Carl T.; Hamrick, Shannon E.G.; Dysart, Kevin C.; Cotten, C. Michael; Truog, William E.; Watterberg, Kristi L.; Timan, Christopher J.; Garg, Meena; Carlo, Waldemar A.; Higgins, Rosemary D.; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network; Pediatrics, School of MedicineImportance: Compared with normothermia, hypothermia has been shown to reduce death or disability in neonatal hypoxic ischemic encephalopathy but data on seizures during rewarming and associated outcomes are scarce. Objective: To determine whether electrographic seizures are more likely to occur during rewarming compared with the preceding period and whether they are associated with abnormal outcomes in asphyxiated neonates receiving hypothermia therapy. Design, setting, and participants: This prespecified nested cohort study of infants enrolled in the Optimizing Cooling (OC) multicenter Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network trial from December 2011 to December 2013 with 2 years' follow-up randomized infants to either 72 hours of cooling (group A) or 120 hours (group B). The main trial included 364 infants. Of these, 194 were screened, 10 declined consent, and 120 met all predefined inclusion criteria. A total of 112 (90%) had complete data for death or disability. Data were analyzed from January 2018 to January 2020. Interventions: Serial amplitude electroencephalography recordings were compared in the 12 hours prior and 12 hours during rewarming for evidence of electrographic seizure activity by 2 central amplitude-integrated electroencephalography readers blinded to treatment arm and rewarming epoch. Odds ratios and 95% CIs were evaluated following adjustment for center, prior seizures, depth of cooling, and encephalopathy severity. Main outcomes and measures: The primary outcome was the occurrence of electrographic seizures during rewarming initiated at 72 or 120 hours compared with the preceding 12-hour epoch. Secondary outcomes included death or moderate or severe disability at age 18 to 22 months. The hypothesis was that seizures during rewarming were associated with higher odds of abnormal neurodevelopmental outcomes. Results: A total of 120 newborns (70 male [58%]) were enrolled (66 in group A and 54 in group B). The mean (SD) gestational age was 39 (1) weeks. There was excellent interrater agreement (κ, 0.99) in detection of seizures. More infants had electrographic seizures during the rewarming epoch compared with the preceding epoch (group A, 27% vs 14%; P = .001; group B, 21% vs 10%; P = .03). Adjusted odd ratios (95% CIs) for seizure frequency during rewarming were 2.7 (1.0-7.5) for group A and 3.2 (0.9-11.6) for group B. The composite death or moderate to severe disability outcome at 2 years was significantly higher in infants with electrographic seizures during rewarming (relative risk [95% CI], 1.7 [1.25-2.37]) after adjusting for baseline clinical encephalopathy and seizures as well as center. Conclusions and relevance: Findings that higher odds of electrographic seizures during rewarming are associated with death or disability at 2 years highlight the necessity of electroencephalography monitoring during rewarming in infants at risk.Item Hypothermia for Patients Requiring Evacuation of Subdural Hematoma: A Multicenter Randomized Clinical Trial(Springer, 2022) Hergenroeder, Georgene W.; Yokobori, Shoji; Choi, Huimahn Alex; Schmitt, Karl; Detry, Michelle A.; Schmitt, Lisa H.; McGlothlin, Anna; Puccio, Ava M.; Jagid, Jonathan; Kuroda, Yasuhiro; Nakamura, Yukihiko; Suehiro, Eiichi; Ahmad, Faiz; Viele, Kert; Wilde, Elisabeth A.; McCauley, Stephen R.; Kitagawa, Ryan S.; Temkin, Nancy R.; Timmons, Shelly D.; Diringer, Michael N.; Dash, Pramod K.; Bullock, Ross; Okonkwo, David O.; Berry, Donald A.; Kim, Dong H.; Neurological Surgery, School of MedicineBackground: Hypothermia is neuroprotective in some ischemia-reperfusion injuries. Ischemia-reperfusion injury may occur with traumatic subdural hematoma (SDH). This study aimed to determine whether early induction and maintenance of hypothermia in patients with acute SDH would lead to decreased ischemia-reperfusion injury and improve global neurologic outcome. Methods: This international, multicenter randomized controlled trial enrolled adult patients with SDH requiring evacuation of hematoma within 6 h of injury. The intervention was controlled temperature management of hypothermia to 35 °C prior to dura opening followed by 33 °C for 48 h compared with normothermia (37 °C). Investigators randomly assigned patients at a 1:1 ratio between hypothermia and normothermia. Blinded evaluators assessed outcome using a 6-month Glasgow Outcome Scale Extended score. Investigators measured circulating glial fibrillary acidic protein and ubiquitin C-terminal hydrolase L1 levels. Results: Independent statisticians performed an interim analysis of 31 patients to assess the predictive probability of success and the Data and Safety Monitoring Board recommended the early termination of the study because of futility. Thirty-two patients, 16 per arm, were analyzed. Favorable 6-month Glasgow Outcome Scale Extended outcomes were not statistically significantly different between hypothermia vs. normothermia groups (6 of 16, 38% vs. 4 of 16, 25%; odds ratio 1.8 [95% confidence interval 0.39 to ∞], p = .35). Plasma levels of glial fibrillary acidic protein (p = .036), but not ubiquitin C-terminal hydrolase L1 (p = .26), were lower in the patients with favorable outcome compared with those with unfavorable outcome, but differences were not identified by temperature group. Adverse events were similar between groups. Conclusions: This trial of hypothermia after acute SDH evacuation was terminated because of a low predictive probability of meeting the study objectives. There was no statistically significant difference in functional outcome identified between temperature groups.Item Increasing the Effectiveness of Targeted Temperature Management(American Association of Critical-Care Nurses, 2021) Moreda, Melissa; Beacham, Pamela S.; Reese, Angela; Mulkey, Malissa A.; School of NursingTopic: Targeted temperature management and therapeutic hypothermia are essential components of the multimodal approach to caring for compromised patients after cardiac arrest and severe traumatic brain injury. Clinical relevance: The continuously evolving science necessitates summation of individual facets and concepts to enhance knowledge and application for optimally delivering care. Targeted temperature management is a complex therapy that requires fine-tuning the most effective interventions to maintain high-quality targeted temperature management and maximize patient outcomes. Purpose: To describe the underlying pathophysiology of fever and the importance of manipulating water temperature and of preventing and treating shivering during that process. Content covered: This article discusses nursing considerations regarding the care of patients requiring targeted temperature management that are necessary to improve patient outcomes.Item Trial of Erythropoietin for Hypoxic-Ischemic Encephalopathy in Newborns(Massachusetts Medical Society, 2022) Wu, Yvonne W.; Comstock, Bryan A.; Gonzalez, Fernando F.; Mayock, Dennis E.; Goodman, Amy M.; Maitre, Nathalie L.; Chang, Taeun; Van Meurs, Krisa P.; Lampland, Andrea L.; Bendel-Stenzel, Ellen; Mathur, Amit M.; Wu, Tai-Wei; Riley, David; Mietzsch, Ulrike; Chalak, Lina; Flibotte, John; Weitkamp, Joern-Hendrik; Ahmad, Kaashif A.; Yanowitz, Toby D.; Baserga, Mariana; Poindexter, Brenda B.; Rogers, Elizabeth E.; Lowe, Jean R.; Kuban, Karl C. K.; O'Shea, T. Michael; Wisnowski, Jessica L.; McKinstry, Robert C.; Bluml, Stefan; Bonifacio, Sonia; Benninger, Kristen L.; Rao, Rakesh; Smyser, Christopher D.; Sokol, Gregory M.; Merhar, Stephanie; Schreiber, Michael D.; Glass, Hannah C.; Heagerty, Patrick J.; Juul, Sandra E.; HEAL Consortium; Pediatrics, School of MedicineBackground: Neonatal hypoxic-ischemic encephalopathy is an important cause of death as well as long-term disability in survivors. Erythropoietin has been hypothesized to have neuroprotective effects in infants with hypoxic-ischemic encephalopathy, but its effects on neurodevelopmental outcomes when given in conjunction with therapeutic hypothermia are unknown. Methods: In a multicenter, double-blind, randomized, placebo-controlled trial, we assigned 501 infants born at 36 weeks or more of gestation with moderate or severe hypoxic-ischemic encephalopathy to receive erythropoietin or placebo, in conjunction with standard therapeutic hypothermia. Erythropoietin (1000 U per kilogram of body weight) or saline placebo was administered intravenously within 26 hours after birth, as well as at 2, 3, 4, and 7 days of age. The primary outcome was death or neurodevelopmental impairment at 22 to 36 months of age. Neurodevelopmental impairment was defined as cerebral palsy, a Gross Motor Function Classification System level of at least 1 (on a scale of 0 [normal] to 5 [most impaired]), or a cognitive score of less than 90 (which corresponds to 0.67 SD below the mean, with higher scores indicating better performance) on the Bayley Scales of Infant and Toddler Development, third edition. Results: Of 500 infants in the modified intention-to-treat analysis, 257 received erythropoietin and 243 received placebo. The incidence of death or neurodevelopmental impairment was 52.5% in the erythropoietin group and 49.5% in the placebo group (relative risk, 1.03; 95% confidence interval [CI], 0.86 to 1.24; P = 0.74). The mean number of serious adverse events per child was higher in the erythropoietin group than in the placebo group (0.86 vs. 0.67; relative risk, 1.26; 95% CI, 1.01 to 1.57). Conclusions: The administration of erythropoietin to newborns undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy did not result in a lower risk of death or neurodevelopmental impairment than placebo and was associated with a higher rate of serious adverse events.