Conivaptan for the Reduction of Cerebral Edema in Intracerebral Hemorrhage- A Safety and Tolerability Study

Enrolling by invitation

Phase N/A Results N/A

References

Publications

  • Annane D, Decaux G, Smith N; Conivaptan Study Group.. Efficacy and safety of oral conivaptan, a vasopressin-receptor antagonist, evaluated in a randomized, controlled trial in patients with euvolemic or hypervolemic hyponatremia. Am J Med Sci. 2009 Jan;337(1):28-36. doi: 10.1097/MAJ.0b013e31817b8148. Pubmed ID:19057376
  • Bulger EM, May S, Brasel KJ, Schreiber M, Kerby JD, Tisherman SA, Newgard C, Slutsky A, Coimbra R, Emerson S, Minei JP, Bardarson B, Kudenchuk P, Baker A, Christenson J, Idris A, Davis D, Fabian TC, Aufderheide TP, Callaway C, Williams C, Banek J, Vaillancourt C, van Heest R, Sopko G, Hata JS, Hoyt DB; ROC Investigators.. Out-of-hospital hypertonic resuscitation following severe traumatic brain injury: a randomized controlled trial. JAMA. 2010 Oct 6;304(13):1455-64. doi: 10.1001/jama.2010.1405. Pubmed ID:20924011
  • Chesnut RM, Temkin N, Carney N, Dikmen S, Rondina C, Videtta W, Petroni G, Lujan S, Pridgeon J, Barber J, Machamer J, Chaddock K, Celix JM, Cherner M, Hendrix T; Global Neurotrauma Research Group.. A trial of intracranial-pressure monitoring in traumatic brain injury. N Engl J Med. 2012 Dec 27;367(26):2471-81. doi: 10.1056/NEJMoa1207363. Epub 2012 Dec 12. Erratum in: N Engl J Med. 2013 Dec 19;369(25):2465. Pubmed ID:23234472
  • Corry JJ, Varelas P, Abdelhak T, Morris S, Hawley M, Hawkins A, Jankowski M. Variable change in renal function by hypertonic saline. World J Crit Care Med. 2014 May 4;3(2):61-7. doi: 10.5492/wjccm.v3.i2.61. Pubmed ID:24892021
  • Corry JJ. The use of targeted temperature management for elevated intracranial pressure. Curr Neurol Neurosci Rep. 2014 Jun;14(6):453. doi: 10.1007/s11910-014-0453-9. Review. Pubmed ID:24740807
  • Corry JJ. Use of hypothermia in the intensive care unit. World J Crit Care Med. 2012 Aug 4;1(4):106-22. doi: 10.5492/wjccm.v1.i4.106. eCollection 2012 Aug 4. Review. Pubmed ID:24701408
  • Costello-Boerrigter LC, Boerrigter G, Burnett JC Jr. Pharmacology of vasopressin antagonists. Heart Fail Rev. 2009 Jun;14(2):75-82. doi: 10.1007/s10741-008-9108-8. Epub 2008 Sep 3. Review. Pubmed ID:18766438
  • Adams Jr HP. Handbook of Cerebrovascular Disease. Ed.2 Marcel Dekker, Inc, New York, 2005
  • Dhar R, Murphy-Human T. A bolus of conivaptan lowers intracranial pressure in a patient with hyponatremia after traumatic brain injury. Neurocrit Care. 2011 Feb;14(1):97-102. doi: 10.1007/s12028-010-9366-x. Pubmed ID:20440600
  • Diringer MN, Edwards DF. Admission to a neurologic/neurosurgical intensive care unit is associated with reduced mortality rate after intracerebral hemorrhage. Crit Care Med. 2001 Mar;29(3):635-40. Pubmed ID:11373434
  • Fernández N, Martínez MA, García-Villalón AL, Monge L, Diéguez G. Cerebral vasoconstriction produced by vasopressin in conscious goats: role of vasopressin V(1) and V(2) receptors and nitric oxide. Br J Pharmacol. 2001 Apr;132(8):1837-44. Pubmed ID:11309256
  • Galton C, Deem S, Yanez ND, Souter M, Chesnut R, Dagal A, Treggiari M. Open-label randomized trial of the safety and efficacy of a single dose conivaptan to raise serum sodium in patients with traumatic brain injury. Neurocrit Care. 2011 Jun;14(3):354-60. doi: 10.1007/s12028-011-9525-8. Pubmed ID:21409494
  • Gazitúa S, Scott JB, Chou CC, Haddy FJ. Effect of osmolarity on canine renal vascular resistance. Am J Physiol. 1969 Oct;217(4):1216-23. Pubmed ID:5824323
  • Gebel JM Jr, Jauch EC, Brott TG, Khoury J, Sauerbeck L, Salisbury S, Spilker J, Tomsick TA, Duldner J, Broderick JP. Natural history of perihematomal edema in patients with hyperacute spontaneous intracerebral hemorrhage. Stroke. 2002 Nov;33(11):2631-5. Pubmed ID:12411653
  • Grände PO, Romner B. Osmotherapy in brain edema: a questionable therapy. J Neurosurg Anesthesiol. 2012 Oct;24(4):407-12. doi: 10.1097/01.ana.0000419730.29492.8b. Review. Pubmed ID:22955195
  • Hemphill JC 3rd, Bonovich DC, Besmertis L, Manley GT, Johnston SC. The ICH score: a simple, reliable grading scale for intracerebral hemorrhage. Stroke. 2001 Apr;32(4):891-7. Pubmed ID:11283388
  • Kleindienst A, Fazzina G, Dunbar JG, Glisson R, Marmarou A. Protective effect of the V1a receptor antagonist SR49059 on brain edema formation following middle cerebral artery occlusion in the rat. Acta Neurochir Suppl. 2006;96:303-6. Pubmed ID:16671476
  • Li YH, Sun SQ. [Expression of aquaporin - 4 protein in brain from rats with hemorrhagic edema]. Zhongguo Wei Zhong Bing Ji Jiu Yi Xue. 2003 Sep;15(9):538-41. Chinese. Pubmed ID:12971848
  • Liu X, Nakayama S, Amiry-Moghaddam M, Ottersen OP, Bhardwaj A. Arginine-vasopressin V1 but not V2 receptor antagonism modulates infarct volume, brain water content, and aquaporin-4 expression following experimental stroke. Neurocrit Care. 2010 Feb;12(1):124-31. doi: 10.1007/s12028-009-9277-x. Pubmed ID:19806476
  • Marik PE, Rivera R. Therapeutic effect of conivaptan bolus dosing in hyponatremic neurosurgical patients. Pharmacotherapy. 2013 Jan;33(1):51-5. doi: 10.1002/phar.1169. Pubmed ID:23307545
  • Mayer SA, Sacco RL, Shi T, Mohr JP. Neurologic deterioration in noncomatose patients with supratentorial intracerebral hemorrhage. Neurology. 1994 Aug;44(8):1379-84. Pubmed ID:8058133
  • McGraw CP, Howard G. Effect of mannitol on increased intracranial pressure. Neurosurgery. 1983 Sep;13(3):269-71. Pubmed ID:6413884
  • Migliati ER, Amiry-Moghaddam M, Froehner SC, Adams ME, Ottersen OP, Bhardwaj A. Na(+)-K (+)-2Cl (-) cotransport inhibitor attenuates cerebral edema following experimental stroke via the perivascular pool of aquaporin-4. Neurocrit Care. 2010 Aug;13(1):123-31. doi: 10.1007/s12028-010-9376-8. Pubmed ID:20458553
  • Murphy T, Dhar R, Diringer M. Conivaptan bolus dosing for the correction of hyponatremia in the neurointensive care unit. Neurocrit Care. 2009;11(1):14-9. doi: 10.1007/s12028-008-9179-3. Epub 2009 Jan 4. Pubmed ID:19123060
  • Naidech AM, Paparello J, Liebling SM, Bassin SL, Levasseur K, Alberts MJ, Bernstein RA, Muro K. Use of Conivaptan (Vaprisol) for hyponatremic neuro-ICU patients. Neurocrit Care. 2010 Aug;13(1):57-61. doi: 10.1007/s12028-010-9379-5. Erratum in: Neurocrit Care. 2011 Aug;15(1):210. Leibling, Storm M [corrected to Liebling, Storm M]. Pubmed ID:20568023
  • Nathan BR. Cerebral correlates of hyponatremia. Neurocrit Care. 2007;6(1):72-8. Pubmed ID:17356196
  • Nau R, Desel H, Lassek C, Thiel A, Schinschke S, Rössing R, Kolenda H, Prange HW. Slow elimination of mannitol from human cerebrospinal fluid. Eur J Clin Pharmacol. 1997;53(3-4):271-4. Pubmed ID:9476044
  • Rosenberg GA, Scremin O, Estrada E, Kyner WT. Arginine vasopressin V1-antagonist and atrial natriuretic peptide reduce hemorrhagic brain edema in rats. Stroke. 1992 Dec;23(12):1767-73; discussion 1773-4. Erratum in: Stroke 1993 Jun;24(6):913. Pubmed ID:1448828
  • Sheth KN, Kimberly WT, Elm JJ, Kent TA, Mandava P, Yoo AJ, Thomalla G, Campbell B, Donnan GA, Davis SM, Albers GW, Jacobson S, Simard JM, Stern BJ. Pilot study of intravenous glyburide in patients with a large ischemic stroke. Stroke. 2014 Jan;45(1):281-3. doi: 10.1161/STROKEAHA.113.003352. Epub 2013 Nov 5. Pubmed ID:24193798
  • Strandvik GF. Hypertonic saline in critical care: a review of the literature and guidelines for use in hypotensive states and raised intracranial pressure. Anaesthesia. 2009 Sep;64(9):990-1003. doi: 10.1111/j.1365-2044.2009.05986.x. Review. Pubmed ID:19686485
  • Sun Z, Zhao Z, Zhao S, Sheng Y, Zhao Z, Gao C, Li J, Liu X. Recombinant hirudin treatment modulates aquaporin-4 and aquaporin-9 expression after intracerebral hemorrhage in vivo. Mol Biol Rep. 2009 May;36(5):1119-27. doi: 10.1007/s11033-008-9287-3. Epub 2008 Jun 24. Pubmed ID:18574711
  • Szmydynger-Chodobska J, Chung I, Koźniewska E, Tran B, Harrington FJ, Duncan JA, Chodobski A. Increased expression of vasopressin v1a receptors after traumatic brain injury. J Neurotrauma. 2004 Aug;21(8):1090-102. Pubmed ID:15319008
  • Taya K, Gulsen S, Okuno K, Prieto R, Marmarou CR, Marmarou A. Modulation of AQP4 expression by the selective V1a receptor antagonist, SR49059, decreases trauma-induced brain edema. Acta Neurochir Suppl. 2008;102:425-9. Pubmed ID:19388360
  • Thiex R, Tsirka SE. Brain edema after intracerebral hemorrhage: mechanisms, treatment options, management strategies, and operative indications. Neurosurg Focus. 2007 May 15;22(5):E6. Review. Pubmed ID:17613237
  • Taylor TN, Davis PH, Torner JC, Holmes J, Meyer JW, Jacobson MF. Lifetime cost of stroke in the United States. Stroke. 1996 Sep;27(9):1459-66. Review. Pubmed ID:8784113
  • Trabold R, Krieg S, Schöller K, Plesnila N. Role of vasopressin V(1a) and V2 receptors for the development of secondary brain damage after traumatic brain injury in mice. J Neurotrauma. 2008 Dec;25(12):1459-65. doi: 10.1089/neu.2008.0597. Pubmed ID:19118456
  • Venkatasubramanian C, Mlynash M, Finley-Caulfield A, Eyngorn I, Kalimuthu R, Snider RW, Wijman CA. Natural history of perihematomal edema after intracerebral hemorrhage measured by serial magnetic resonance imaging. Stroke. 2011 Jan;42(1):73-80. doi: 10.1161/STROKEAHA.110.590646. Epub 2010 Dec 16. Pubmed ID:21164136
  • Verbalis JG, Zeltser D, Smith N, Barve A, Andoh M. Assessment of the efficacy and safety of intravenous conivaptan in patients with euvolaemic hyponatraemia: subgroup analysis of a randomized, controlled study. Clin Endocrinol (Oxf). 2008 Jul;69(1):159-68. Epub 2008 Jul 1. Pubmed ID:18034777
  • Volbers B, Willfarth W, Kuramatsu JB, Struffert T, Dörfler A, Huttner HB, Schwab S, Staykov D. Impact of Perihemorrhagic Edema on Short-Term Outcome After Intracerebral Hemorrhage. Neurocrit Care. 2016 Jun;24(3):404-12. doi: 10.1007/s12028-015-0185-y. Pubmed ID:26381282
  • Wilcox CS. Regulation of renal blood flow by plasma chloride. J Clin Invest. 1983 Mar;71(3):726-35. Pubmed ID:6826732
  • Wright WL, Asbury WH, Gilmore JL, Samuels OB. Conivaptan for hyponatremia in the neurocritical care unit. Neurocrit Care. 2009;11(1):6-13. doi: 10.1007/s12028-008-9152-1. Epub 2008 Nov 12. Pubmed ID:19003543
  • Yool AJ, Brown EA, Flynn GA. Roles for novel pharmacological blockers of aquaporins in the treatment of brain oedema and cancer. Clin Exp Pharmacol Physiol. 2010 Apr;37(4):403-9. doi: 10.1111/j.1440-1681.2009.05244.x. Epub 2009 Jun 29. Review. Pubmed ID:19566827
  • Zeltser D, Rosansky S, van Rensburg H, Verbalis JG, Smith N; Conivaptan Study Group.. Assessment of the efficacy and safety of intravenous conivaptan in euvolemic and hypervolemic hyponatremia. Am J Nephrol. 2007;27(5):447-57. Epub 2007 Jul 26. Pubmed ID:17664863
  • Zeynalov E, Chen CH, Froehner SC, Adams ME, Ottersen OP, Amiry-Moghaddam M, Bhardwaj A. The perivascular pool of aquaporin-4 mediates the effect of osmotherapy in postischemic cerebral edema. Crit Care Med. 2008 Sep;36(9):2634-40. doi: 10.1097/CCM.0b013e3181847853. Pubmed ID:18679106

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