Clinical trial NCT03376854 - References

Sars-CoV2 — Pilot RCT of Therapeutic Hypothermia Plus Neuromuscular Blockade in COVID-19 Patients With ARDS

Citation(s)

•   Acute Respiratory Distress Syndrome Network, Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A
  Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8.
•   Ball MK, Hillman NH, Kallapur SG, Polglase GR, Jobe AH, Pillow JJ
  Body temperature effects on lung injury in ventilated preterm lambs. Resuscitation. 2010 Jun;81(6):749-54. doi: 10.1016/j.resuscitation.2009.12.007. Epub 2010 Mar 17.
•   Beitler JR, Sands SA, Loring SH, Owens RL, Malhotra A, Spragg RG, Matthay MA, Thompson BT, Talmor D
  Quantifying unintended exposure to high tidal volumes from breath stacking dyssynchrony in ARDS: the BREATHE criteria. Intensive Care Med. 2016 Sep;42(9):1427-36. doi: 10.1007/s00134-016-4423-3. Epub 2016 Jun 24.
•   Beurskens CJ, Aslami H, Kuipers MT, Horn J, Vroom MB, van Kuilenburg AB, Roelofs JJ, Schultz MJ, Juffermans NP
  Induced hypothermia is protective in a rat model of pneumococcal pneumonia associated with increased adenosine triphosphate availability and turnover*. Crit Care Med. 2012 Mar;40(3):919-26. doi: 10.1097/CCM.0b013e3182373174.
•   Brown SM, Grissom CK, Moss M, Rice TW, Schoenfeld D, Hou PC, Thompson BT, Brower RG; NIH/NHLBI PETAL Network Collaborators
  Nonlinear Imputation of Pao2/Fio2 From Spo2/Fio2 Among Patients With Acute Respiratory Distress Syndrome. Chest. 2016 Aug;150(2):307-13. doi: 10.1016/j.chest.2016.01.003. Epub 2016 Jan 19.
•   Calfee CS, Eisner MD, Parsons PE, Thompson BT, Conner ER Jr, Matthay MA, Ware LB; NHLBI Acute Respiratory Distress Syndrome Clinical Trials Network
  Soluble intercellular adhesion molecule-1 and clinical outcomes in patients with acute lung injury. Intensive Care Med. 2009 Feb;35(2):248-57. doi: 10.1007/s00134-008-1235-0. Epub 2008 Aug 1. Review.
•   Calfee CS, Ware LB, Eisner MD, Parsons PE, Thompson BT, Wickersham N, Matthay MA; NHLBI ARDS Network
  Plasma receptor for advanced glycation end products and clinical outcomes in acute lung injury. Thorax. 2008 Dec;63(12):1083-9. doi: 10.1136/thx.2008.095588. Epub 2008 Jun 19.
•   Chang H, Huang KL, Li MH, Hsu CW, Tsai SH, Chu SJ
  Manipulations of core temperatures in ischemia-reperfusion lung injury in rabbits. Pulm Pharmacol Ther. 2008;21(2):285-91. Epub 2007 Jun 14.
•   Chin JY, Koh Y, Kim MJ, Kim HS, Kim WS, Kim DS, Kim WD, Lim CM
  The effects of hypothermia on endotoxin-primed lung. Anesth Analg. 2007 May;104(5):1171-8, tables of contents.
•   Cruces P, Erranz B, Donoso A, Carvajal C, Salomón T, Torres MF, Díaz F
  Mild hypothermia increases pulmonary anti-inflammatory response during protective mechanical ventilation in a piglet model of acute lung injury. Paediatr Anaesth. 2013 Nov;23(11):1069-77. doi: 10.1111/pan.12209. Epub 2013 Jun 3.
•   Ferguson ND, Fan E, Camporota L, Antonelli M, Anzueto A, Beale R, Brochard L, Brower R, Esteban A, Gattinoni L, Rhodes A, Slutsky AS, Vincent JL, Rubenfeld GD, Thompson BT, Ranieri VM
  The Berlin definition of ARDS: an expanded rationale, justification, and supplementary material. Intensive Care Med. 2012 Oct;38(10):1573-82. Epub 2012 Aug 25. Erratum in: Intensive Care Med. 2012 Oct;38(10):1731-2.
•   Gattinoni L, Tonetti T, Cressoni M, Cadringher P, Herrmann P, Moerer O, Protti A, Gotti M, Chiurazzi C, Carlesso E, Chiumello D, Quintel M
  Ventilator-related causes of lung injury: the mechanical power. Intensive Care Med. 2016 Oct;42(10):1567-1575. doi: 10.1007/s00134-016-4505-2. Epub 2016 Sep 12.
•   Greene KE, Wright JR, Steinberg KP, Ruzinski JT, Caldwell E, Wong WB, Hull W, Whitsett JA, Akino T, Kuroki Y, Nagae H, Hudson LD, Martin TR
  Serial changes in surfactant-associated proteins in lung and serum before and after onset of ARDS. Am J Respir Crit Care Med. 1999 Dec;160(6):1843-50.
•   Guérin C, Mancebo J
  Prone positioning and neuromuscular blocking agents are part of standard care in severe ARDS patients: yes. Intensive Care Med. 2015 Dec;41(12):2195-7. doi: 10.1007/s00134-015-3918-7. Epub 2015 Sep 23.
•   Guérin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group
  Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.
•   Hasday JD, Garrison A, Singh IS, Standiford T, Ellis GS, Rao S, He JR, Rice P, Frank M, Goldblum SE, Viscardi RM
  Febrile-range hyperthermia augments pulmonary neutrophil recruitment and amplifies pulmonary oxygen toxicity. Am J Pathol. 2003 Jun;162(6):2005-17.
•   Huang PS, Tang GJ, Chen CH, Kou YR
  Whole-body moderate hypothermia confers protection from wood smoke-induced acute lung injury in rats: the therapeutic window. Crit Care Med. 2006 Apr;34(4):1160-7.
•   Jo YH, Kim K, Rhee JE, Suh GJ, Kwon WY, Na SH, Alam HB
  Therapeutic hypothermia attenuates acute lung injury in paraquat intoxication in rats. Resuscitation. 2011 Apr;82(4):487-91. doi: 10.1016/j.resuscitation.2010.11.028. Epub 2011 Jan 14.
•   Karnatovskaia LV, Festic E, Freeman WD, Lee AS
  Effect of therapeutic hypothermia on gas exchange and respiratory mechanics: a retrospective cohort study. Ther Hypothermia Temp Manag. 2014 Jun;4(2):88-95. doi: 10.1089/ther.2014.0004. Epub 2014 May 19.
•   Kim K, Kim W, Rhee JE, Jo YH, Lee JH, Kim KS, Kwon WY, Suh GJ, Lee CC, Singer AJ
  Induced hypothermia attenuates the acute lung injury in hemorrhagic shock. J Trauma. 2010 Feb;68(2):373-81. doi: 10.1097/TA.0b013e3181a73eea.
•   Kimura D, Saravia J, Rovnaghi CR, Meduri GU, Schwingshackl A, Cormier SA, Anand KJ
  Plasma Biomarker Analysis in Pediatric ARDS: Generating Future Framework from a Pilot Randomized Control Trial of Methylprednisolone: A Framework for Identifying Plasma Biomarkers Related to Clinical Outcomes in Pediatric ARDS. Front Pediatr. 2016 Mar 31;4:31. doi: 10.3389/fped.2016.00031. eCollection 2016.
•   Kira S, Daa T, Kashima K, Mori M, Noguchi T, Yokoyama S
  Mild hypothermia reduces expression of intercellular adhesion molecule-1 (ICAM-1) and the accumulation of neutrophils after acid-induced lung injury in the rat. Acta Anaesthesiol Scand. 2005 Mar;49(3):351-9.
•   Lim CM, Hong SB, Koh Y, Lee SD, Kim WS, Kim DS, Kim WD
  Hypothermia attenuates vascular manifestations of ventilator-induced lung injury in rats. Lung. 2003;181(1):23-34.
•   Lim CM, Kim MS, Ahn JJ, Kim MJ, Kwon Y, Lee I, Koh Y, Kim DS, Kim WD
  Hypothermia protects against endotoxin-induced acute lung injury in rats. Intensive Care Med. 2003 Mar;29(3):453-9. Epub 2002 Nov 22.
•   Lipke AB, Matute-Bello G, Herrero R, Kurahashi K, Wong VA, Mongovin SM, Martin TR
  Febrile-range hyperthermia augments lipopolysaccharide-induced lung injury by a mechanism of enhanced alveolar epithelial apoptosis. J Immunol. 2010 Apr 1;184(7):3801-13. doi: 10.4049/jimmunol.0903191. Epub 2010 Mar 3.
•   Lipke AB, Matute-Bello G, Herrero R, Wong VA, Mongovin SM, Martin TR
  Death receptors mediate the adverse effects of febrile-range hyperthermia on the outcome of lipopolysaccharide-induced lung injury. Am J Physiol Lung Cell Mol Physiol. 2011 Jul;301(1):L60-70. doi: 10.1152/ajplung.00314.2010. Epub 2011 Apr 22.
•   Manthous CA, Hall JB, Olson D, Singh M, Chatila W, Pohlman A, Kushner R, Schmidt GA, Wood LD
  Effect of cooling on oxygen consumption in febrile critically ill patients. Am J Respir Crit Care Med. 1995 Jan;151(1):10-4.
•   Nagarsekar A, Tulapurkar ME, Singh IS, Atamas SP, Shah NG, Hasday JD
  Hyperthermia promotes and prevents respiratory epithelial apoptosis through distinct mechanisms. Am J Respir Cell Mol Biol. 2012 Dec;47(6):824-33. doi: 10.1165/rcmb.2012-0105OC. Epub 2012 Sep 6.
•   Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guérin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators
  Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.
•   Peng CK, Huang KL, Wu CP, Li MH, Lin HI, Hsu CW, Tsai SH, Chu SJ
  The role of mild hypothermia in air embolism-induced acute lung injury. Anesth Analg. 2010 May 1;110(5):1336-42. doi: 10.1213/ANE.0b013e3181d27e90.
•   Potla R, Singh IS, Atamas SP, Hasday JD
  Shifts in temperature within the physiologic range modify strand-specific expression of select human microRNAs. RNA. 2015 Jul;21(7):1261-73. doi: 10.1261/rna.049122.114. Epub 2015 May 27.
•   Rice P, Martin E, He JR, Frank M, DeTolla L, Hester L, O'Neill T, Manka C, Benjamin I, Nagarsekar A, Singh I, Hasday JD
  Febrile-range hyperthermia augments neutrophil accumulation and enhances lung injury in experimental gram-negative bacterial pneumonia. J Immunol. 2005 Mar 15;174(6):3676-85.
•   Shah NG, Cowan MJ, Pickering E, Sareh H, Afshar M, Fox D, Marron J, Davis J, Herold K, Shanholtz CB, Hasday JD
  Nonpharmacologic approach to minimizing shivering during surface cooling: a proof of principle study. J Crit Care. 2012 Dec;27(6):746.e1-8. doi: 10.1016/j.jcrc.2012.04.016. Epub 2012 Jul 2.
•   Shah NG, Tulapurkar ME, Damarla M, Singh IS, Goldblum SE, Shapiro P, Hasday JD
  Febrile-range hyperthermia augments reversible TNF-a-induced hyperpermeability in human microvascular lung endothelial cells. Int J Hyperthermia. 2012;28(7):627-35. doi: 10.3109/02656736.2012.690547. Epub 2012 Jul 26.
•   Slack DF, Corwin DS, Shah NG, Shanholtz CB, Verceles AC, Netzer G, Jones KM, Brown CH, Terrin ML, Hasday JD
  Pilot Feasibility Study of Therapeutic Hypothermia for Moderate to Severe Acute Respiratory Distress Syndrome. Crit Care Med. 2017 Jul;45(7):1152-1159. doi: 10.1097/CCM.0000000000002338.
•   Tang ZH, Hu JT, Lu ZC, Ji XF, Chen XF, Jiang LY, Zhang C, Jiang JS, Pang YP, Li CQ
  Effect of mild hypothermia on the expression of toll-like receptor 2 in lung tissues with experimental acute lung injury. Heart Lung Circ. 2014 Dec;23(12):1202-7. doi: 10.1016/j.hlc.2014.05.016. Epub 2014 Jun 24.
•   Tulapurkar ME, Almutairy EA, Shah NG, He JR, Puche AC, Shapiro P, Singh IS, Hasday JD
  Febrile-range hyperthermia modifies endothelial and neutrophilic functions to promote extravasation. Am J Respir Cell Mol Biol. 2012 Jun;46(6):807-14. doi: 10.1165/rcmb.2011-0378OC. Epub 2012 Jan 26.
•   Villar J, Blanco J, Kacmarek RM
  Current incidence and outcome of the acute respiratory distress syndrome. Curr Opin Crit Care. 2016 Feb;22(1):1-6. doi: 10.1097/MCC.0000000000000266. Review.
•   Villar J, Slutsky AS
  Effects of induced hypothermia in patients with septic adult respiratory distress syndrome. Resuscitation. 1993 Oct;26(2):183-92.

Pilot Randomized Clinical Trial of Therapeutic Hypothermia Plus Neuromuscular Blockade vs. Standard of Care in COVID-19 Patients With Moderate to Severe ARDS - the Cooling to Help Injured Lungs (CHILL) Pilot Study

Details for clinical trial NCT03376854