Therapeutic hypothermia after out-of-hospital cardiac arrest in children

Frank W. Moler, Faye S. Silverstein, Richard Holubkov, Beth S. Slomine, James R. Christensen, Vinay M. Nadkarni, Kathleen L. Meert, Amy E. Clark, Brittan Browning, Victoria L. Pemberton, Kent Page, Seetha Shankaran, Jamie S. Hutchison, Christopher J L Newth, Kimberly S. Bennett, John T. Berger, Alexis Topjian, Jose A. Pineda, Joshua D. Koch, Charles L. SchleienHeidi J. Dalton, George Ofori-Amanfo, Denise M. Goodman, Ericka L. Fink, Patrick McQuillen, Jerry J. Zimmerman, Neal J. Thomas, Elise W. Van Der Jagt, Melissa B. Porter, Michael T. Meyer, Rick Harrison, Nga Pham, Adam J. Schwarz, Jeffrey E. Nowak, Jeffrey Alten, Derek S. Wheeler, Utpal S. Bhalala, Karen Lidsky, Eric Lloyd, Mudit Mathur, Samir Shah, Theodore Wu, Andreas A. Theodorou, Ronald C. Sanders, J. Michael Dean

Research output: Contribution to journalArticle

203 Citations (Scopus)

Abstract

Background: Therapeutic hypothermia is recommended for comatose adults after witnessed outofhospital cardiac arrest, but data about this intervention in children are limited. Methods: We conducted this trial of two targeted temperature interventions at 38 children's hospitals involving children who remained unconscious after out-of-hospital cardiac arrest. Within 6 hours after the return of circulation, comatose patients who were older than 2 days and younger than 18 years of age were randomly assigned to therapeutic hypothermia (target temperature, 33.0°C) or therapeutic normothermia (target temperature, 36.8°C). The primary efficacy outcome, survival at 12 months after cardiac arrest with a Vineland Adaptive Behavior Scales, second edition (VABS-II), score of 70 or higher (on a scale from 20 to 160, with higher scores indicating better function), was evaluated among patients with a VABS-II score of at least 70 before cardiac arrest. Results: A total of 295 patients underwent randomization. Among the 260 patients with data that could be evaluated and who had a VABS-II score of at least 70 before cardiac arrest, there was no significant difference in the primary outcome between the hypothermia group and the normothermia group (20% vs. 12%; relative likelihood, 1.54; 95% confidence interval [CI], 0.86 to 2.76; P = 0.14). Among all the patients with data that could be evaluated, the change in the VABS-II score from baseline to 12 months was not significantly different (P = 0.13) and 1-year survival was similar (38% in the hypothermia group vs. 29% in the normothermia group; relative likelihood, 1.29; 95% CI, 0.93 to 1.79; P = 0.13). The groups had similar incidences of infection and serious arrhythmias, as well as similar use of blood products and 28-day mortality. Conclusions: In comatose children who survived out-of-hospital cardiac arrest, therapeutic hypothermia, as compared with therapeutic normothermia, did not confer a significant benefit in survival with a good functional outcome at 1 year. (Funded by the National Heart, Lung, and Blood Institute and others; THAPCA-OH ClinicalTrials.gov number, NCT00878644.)

Original languageEnglish (US)
Pages (from-to)1898-1908
Number of pages11
JournalNew England Journal of Medicine
Volume372
Issue number20
DOIs
StatePublished - May 14 2015

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Out-of-Hospital Cardiac Arrest
Induced Hypothermia
Psychological Adaptation
Heart Arrest
Coma
Hypothermia
Temperature
Survival
Confidence Intervals
National Heart, Lung, and Blood Institute (U.S.)
Random Allocation
Cardiac Arrhythmias
Mortality
Incidence
Therapeutics
Infection

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Moler, F. W., Silverstein, F. S., Holubkov, R., Slomine, B. S., Christensen, J. R., Nadkarni, V. M., ... Dean, J. M. (2015). Therapeutic hypothermia after out-of-hospital cardiac arrest in children. New England Journal of Medicine, 372(20), 1898-1908. https://doi.org/10.1056/NEJMoa1411480

Therapeutic hypothermia after out-of-hospital cardiac arrest in children. / Moler, Frank W.; Silverstein, Faye S.; Holubkov, Richard; Slomine, Beth S.; Christensen, James R.; Nadkarni, Vinay M.; Meert, Kathleen L.; Clark, Amy E.; Browning, Brittan; Pemberton, Victoria L.; Page, Kent; Shankaran, Seetha; Hutchison, Jamie S.; Newth, Christopher J L; Bennett, Kimberly S.; Berger, John T.; Topjian, Alexis; Pineda, Jose A.; Koch, Joshua D.; Schleien, Charles L.; Dalton, Heidi J.; Ofori-Amanfo, George; Goodman, Denise M.; Fink, Ericka L.; McQuillen, Patrick; Zimmerman, Jerry J.; Thomas, Neal J.; Van Der Jagt, Elise W.; Porter, Melissa B.; Meyer, Michael T.; Harrison, Rick; Pham, Nga; Schwarz, Adam J.; Nowak, Jeffrey E.; Alten, Jeffrey; Wheeler, Derek S.; Bhalala, Utpal S.; Lidsky, Karen; Lloyd, Eric; Mathur, Mudit; Shah, Samir; Wu, Theodore; Theodorou, Andreas A.; Sanders, Ronald C.; Dean, J. Michael.

In: New England Journal of Medicine, Vol. 372, No. 20, 14.05.2015, p. 1898-1908.

Research output: Contribution to journalArticle

Moler, FW, Silverstein, FS, Holubkov, R, Slomine, BS, Christensen, JR, Nadkarni, VM, Meert, KL, Clark, AE, Browning, B, Pemberton, VL, Page, K, Shankaran, S, Hutchison, JS, Newth, CJL, Bennett, KS, Berger, JT, Topjian, A, Pineda, JA, Koch, JD, Schleien, CL, Dalton, HJ, Ofori-Amanfo, G, Goodman, DM, Fink, EL, McQuillen, P, Zimmerman, JJ, Thomas, NJ, Van Der Jagt, EW, Porter, MB, Meyer, MT, Harrison, R, Pham, N, Schwarz, AJ, Nowak, JE, Alten, J, Wheeler, DS, Bhalala, US, Lidsky, K, Lloyd, E, Mathur, M, Shah, S, Wu, T, Theodorou, AA, Sanders, RC & Dean, JM 2015, 'Therapeutic hypothermia after out-of-hospital cardiac arrest in children', New England Journal of Medicine, vol. 372, no. 20, pp. 1898-1908. https://doi.org/10.1056/NEJMoa1411480
Moler FW, Silverstein FS, Holubkov R, Slomine BS, Christensen JR, Nadkarni VM et al. Therapeutic hypothermia after out-of-hospital cardiac arrest in children. New England Journal of Medicine. 2015 May 14;372(20):1898-1908. https://doi.org/10.1056/NEJMoa1411480
Moler, Frank W. ; Silverstein, Faye S. ; Holubkov, Richard ; Slomine, Beth S. ; Christensen, James R. ; Nadkarni, Vinay M. ; Meert, Kathleen L. ; Clark, Amy E. ; Browning, Brittan ; Pemberton, Victoria L. ; Page, Kent ; Shankaran, Seetha ; Hutchison, Jamie S. ; Newth, Christopher J L ; Bennett, Kimberly S. ; Berger, John T. ; Topjian, Alexis ; Pineda, Jose A. ; Koch, Joshua D. ; Schleien, Charles L. ; Dalton, Heidi J. ; Ofori-Amanfo, George ; Goodman, Denise M. ; Fink, Ericka L. ; McQuillen, Patrick ; Zimmerman, Jerry J. ; Thomas, Neal J. ; Van Der Jagt, Elise W. ; Porter, Melissa B. ; Meyer, Michael T. ; Harrison, Rick ; Pham, Nga ; Schwarz, Adam J. ; Nowak, Jeffrey E. ; Alten, Jeffrey ; Wheeler, Derek S. ; Bhalala, Utpal S. ; Lidsky, Karen ; Lloyd, Eric ; Mathur, Mudit ; Shah, Samir ; Wu, Theodore ; Theodorou, Andreas A. ; Sanders, Ronald C. ; Dean, J. Michael. / Therapeutic hypothermia after out-of-hospital cardiac arrest in children. In: New England Journal of Medicine. 2015 ; Vol. 372, No. 20. pp. 1898-1908.
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abstract = "Background: Therapeutic hypothermia is recommended for comatose adults after witnessed outofhospital cardiac arrest, but data about this intervention in children are limited. Methods: We conducted this trial of two targeted temperature interventions at 38 children's hospitals involving children who remained unconscious after out-of-hospital cardiac arrest. Within 6 hours after the return of circulation, comatose patients who were older than 2 days and younger than 18 years of age were randomly assigned to therapeutic hypothermia (target temperature, 33.0°C) or therapeutic normothermia (target temperature, 36.8°C). The primary efficacy outcome, survival at 12 months after cardiac arrest with a Vineland Adaptive Behavior Scales, second edition (VABS-II), score of 70 or higher (on a scale from 20 to 160, with higher scores indicating better function), was evaluated among patients with a VABS-II score of at least 70 before cardiac arrest. Results: A total of 295 patients underwent randomization. Among the 260 patients with data that could be evaluated and who had a VABS-II score of at least 70 before cardiac arrest, there was no significant difference in the primary outcome between the hypothermia group and the normothermia group (20{\%} vs. 12{\%}; relative likelihood, 1.54; 95{\%} confidence interval [CI], 0.86 to 2.76; P = 0.14). Among all the patients with data that could be evaluated, the change in the VABS-II score from baseline to 12 months was not significantly different (P = 0.13) and 1-year survival was similar (38{\%} in the hypothermia group vs. 29{\%} in the normothermia group; relative likelihood, 1.29; 95{\%} CI, 0.93 to 1.79; P = 0.13). The groups had similar incidences of infection and serious arrhythmias, as well as similar use of blood products and 28-day mortality. Conclusions: In comatose children who survived out-of-hospital cardiac arrest, therapeutic hypothermia, as compared with therapeutic normothermia, did not confer a significant benefit in survival with a good functional outcome at 1 year. (Funded by the National Heart, Lung, and Blood Institute and others; THAPCA-OH ClinicalTrials.gov number, NCT00878644.)",
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TY - JOUR

T1 - Therapeutic hypothermia after out-of-hospital cardiac arrest in children

AU - Moler, Frank W.

AU - Silverstein, Faye S.

AU - Holubkov, Richard

AU - Slomine, Beth S.

AU - Christensen, James R.

AU - Nadkarni, Vinay M.

AU - Meert, Kathleen L.

AU - Clark, Amy E.

AU - Browning, Brittan

AU - Pemberton, Victoria L.

AU - Page, Kent

AU - Shankaran, Seetha

AU - Hutchison, Jamie S.

AU - Newth, Christopher J L

AU - Bennett, Kimberly S.

AU - Berger, John T.

AU - Topjian, Alexis

AU - Pineda, Jose A.

AU - Koch, Joshua D.

AU - Schleien, Charles L.

AU - Dalton, Heidi J.

AU - Ofori-Amanfo, George

AU - Goodman, Denise M.

AU - Fink, Ericka L.

AU - McQuillen, Patrick

AU - Zimmerman, Jerry J.

AU - Thomas, Neal J.

AU - Van Der Jagt, Elise W.

AU - Porter, Melissa B.

AU - Meyer, Michael T.

AU - Harrison, Rick

AU - Pham, Nga

AU - Schwarz, Adam J.

AU - Nowak, Jeffrey E.

AU - Alten, Jeffrey

AU - Wheeler, Derek S.

AU - Bhalala, Utpal S.

AU - Lidsky, Karen

AU - Lloyd, Eric

AU - Mathur, Mudit

AU - Shah, Samir

AU - Wu, Theodore

AU - Theodorou, Andreas A.

AU - Sanders, Ronald C.

AU - Dean, J. Michael

PY - 2015/5/14

Y1 - 2015/5/14

N2 - Background: Therapeutic hypothermia is recommended for comatose adults after witnessed outofhospital cardiac arrest, but data about this intervention in children are limited. Methods: We conducted this trial of two targeted temperature interventions at 38 children's hospitals involving children who remained unconscious after out-of-hospital cardiac arrest. Within 6 hours after the return of circulation, comatose patients who were older than 2 days and younger than 18 years of age were randomly assigned to therapeutic hypothermia (target temperature, 33.0°C) or therapeutic normothermia (target temperature, 36.8°C). The primary efficacy outcome, survival at 12 months after cardiac arrest with a Vineland Adaptive Behavior Scales, second edition (VABS-II), score of 70 or higher (on a scale from 20 to 160, with higher scores indicating better function), was evaluated among patients with a VABS-II score of at least 70 before cardiac arrest. Results: A total of 295 patients underwent randomization. Among the 260 patients with data that could be evaluated and who had a VABS-II score of at least 70 before cardiac arrest, there was no significant difference in the primary outcome between the hypothermia group and the normothermia group (20% vs. 12%; relative likelihood, 1.54; 95% confidence interval [CI], 0.86 to 2.76; P = 0.14). Among all the patients with data that could be evaluated, the change in the VABS-II score from baseline to 12 months was not significantly different (P = 0.13) and 1-year survival was similar (38% in the hypothermia group vs. 29% in the normothermia group; relative likelihood, 1.29; 95% CI, 0.93 to 1.79; P = 0.13). The groups had similar incidences of infection and serious arrhythmias, as well as similar use of blood products and 28-day mortality. Conclusions: In comatose children who survived out-of-hospital cardiac arrest, therapeutic hypothermia, as compared with therapeutic normothermia, did not confer a significant benefit in survival with a good functional outcome at 1 year. (Funded by the National Heart, Lung, and Blood Institute and others; THAPCA-OH ClinicalTrials.gov number, NCT00878644.)

AB - Background: Therapeutic hypothermia is recommended for comatose adults after witnessed outofhospital cardiac arrest, but data about this intervention in children are limited. Methods: We conducted this trial of two targeted temperature interventions at 38 children's hospitals involving children who remained unconscious after out-of-hospital cardiac arrest. Within 6 hours after the return of circulation, comatose patients who were older than 2 days and younger than 18 years of age were randomly assigned to therapeutic hypothermia (target temperature, 33.0°C) or therapeutic normothermia (target temperature, 36.8°C). The primary efficacy outcome, survival at 12 months after cardiac arrest with a Vineland Adaptive Behavior Scales, second edition (VABS-II), score of 70 or higher (on a scale from 20 to 160, with higher scores indicating better function), was evaluated among patients with a VABS-II score of at least 70 before cardiac arrest. Results: A total of 295 patients underwent randomization. Among the 260 patients with data that could be evaluated and who had a VABS-II score of at least 70 before cardiac arrest, there was no significant difference in the primary outcome between the hypothermia group and the normothermia group (20% vs. 12%; relative likelihood, 1.54; 95% confidence interval [CI], 0.86 to 2.76; P = 0.14). Among all the patients with data that could be evaluated, the change in the VABS-II score from baseline to 12 months was not significantly different (P = 0.13) and 1-year survival was similar (38% in the hypothermia group vs. 29% in the normothermia group; relative likelihood, 1.29; 95% CI, 0.93 to 1.79; P = 0.13). The groups had similar incidences of infection and serious arrhythmias, as well as similar use of blood products and 28-day mortality. Conclusions: In comatose children who survived out-of-hospital cardiac arrest, therapeutic hypothermia, as compared with therapeutic normothermia, did not confer a significant benefit in survival with a good functional outcome at 1 year. (Funded by the National Heart, Lung, and Blood Institute and others; THAPCA-OH ClinicalTrials.gov number, NCT00878644.)

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