Vasopressin Citations: The Vasopressor & Inotrope Handbook

The following are the citations for my book “The Vasopressor & Inotrope Handbook: A Practical Guide for Healthcare Professionals.” If you stumbled upon this page via a search engine, you have several options to get a copy, as shown below the citations.

  1. Vail EA, Gershengorn HB, Hua M, Walkey AJ, Wunsch H. Epidemiology of Vasopressin Use for Adults with Septic Shock. Ann Am Thorac Soc. 2016 Oct;13(10):1760-1767. doi: 10.1513/AnnalsATS.201604-259OC. PMID: 27404213; PMCID: PMC5122493.
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  2. “Vasopressin Injection, USP.” FDA.gov, U.S. Food and Drug Administration, 2023.
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  3. Holmes CL, Patel BM, Russell JA, Walley KR. Physiology of vasopressin relevant to management of septic shock. Chest. 2001 Sep;120(3):989-1002. doi: 10.1378/chest.120.3.989. PMID: 11555538.
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  4. Landry DW, Levin HR, Gallant EM, Ashton RC Jr, Seo S, D’Alessandro D, Oz MC, Oliver JA. Vasopressin deficiency contributes to the vasodilation of septic shock. Circulation. 1997 Mar 4;95(5):1122-5. doi: 10.1161/01.cir.95.5.1122. PMID: 9054839.
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  5. Sharshar T, Carlier R, Blanchard A, Feydy A, Gray F, Paillard M, Raphael JC, Gajdos P, Annane D. Depletion of neurohypophyseal content of vasopressin in septic shock. Crit Care Med. 2002 Mar;30(3):497-500. doi: 10.1097/00003246-200203000-00001. PMID: 11990905.
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  6. Russell JA, Walley KR, Singer J, Gordon AC, Hébert PC, Cooper DJ, Holmes CL, Mehta S, Granton JT, Storms MM, Cook DJ, Presneill JJ, Ayers D; VASST Investigators. Vasopressin versus norepinephrine infusion in patients with septic shock. N Engl J Med. 2008 Feb 28;358(9):877-87. doi: 10.1056/NEJMoa067373. PMID: 18305265.
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  7. Argenziano M, Chen JM, Choudhri AF, Cullinane S, Garfein E, Weinberg AD, Smith CR Jr, Rose EA, Landry DW, Oz MC. Management of vasodilatory shock after cardiac surgery: identification of predisposing factors and use of a novel pressor agent. J Thorac Cardiovasc Surg. 1998 Dec;116(6):973-80. doi: 10.1016/S0022-5223(98)70049-2. PMID: 9832689.
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  8. Hajjar LA, Vincent JL, Barbosa Gomes Galas FR, Rhodes A, Landoni G, Osawa EA, Melo RR, Sundin MR, Grande SM, Gaiotto FA, Pomerantzeff PM, Dallan LO, Franco RA, Nakamura RE, Lisboa LA, de Almeida JP, Gerent AM, Souza DH, Gaiane MA, Fukushima JT, Park CL, Zambolim C, Rocha Ferreira GS, Strabelli TM, Fernandes FL, Camara L, Zeferino S, Santos VG, Piccioni MA, Jatene FB, Costa Auler JO Jr, Filho RK. Vasopressin versus Norepinephrine in Patients with Vasoplegic Shock after Cardiac Surgery: The VANCS Randomized Controlled Trial. Anesthesiology. 2017 Jan;126(1):85-93. doi: 10.1097/ALN.0000000000001434. PMID: 27841822.
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  9. Möhring J, Glänzer K, Maciel JA Jr, Düsing R, Kramer HJ, Arbogast R, Koch-Weser J. Greatly enhanced pressor response to antidiuretic hormone in patients with impaired cardiovascular reflexes due to idiopathic orthostatic hypotension. J Cardiovasc Pharmacol. 1980 Jul-Aug;2(4):367-76. doi: 10.1097/00005344-198007000-00004. PMID: 6156335.
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  10. Graybiel A, Glendy RE. Circulatory effects following the intravenous administration of pitressin in normal persons and in patients with hypertension and angina pectoris. Am Heart J 1941;21(4):481–9. doi:10.1016/S0002-8703(41)90649-X.
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  11. Malay MB, Ashton RC Jr, Landry DW, Townsend RN. Low-dose vasopressin in the treatment of vasodilatory septic shock. J Trauma. 1999 Oct;47(4):699-703; discussion 703-5. doi: 10.1097/00005373-199910000-00014. PMID: 10528604.
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  12. Patel BM, Chittock DR, Russell JA, Walley KR. Beneficial effects of short-term vasopressin infusion during severe septic shock. Anesthesiology. 2002 Mar;96(3):576-82. doi: 10.1097/00000542-200203000-00011. PMID: 11873030.
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  13. Dünser MW, Mayr AJ, Ulmer H, Knotzer H, Sumann G, Pajk W, Friesenecker B, Hasibeder WR. Arginine vasopressin in advanced vasodilatory shock: a prospective, randomized, controlled study. Circulation. 2003 May 13;107(18):2313-9. doi: 10.1161/01.CIR.0000066692.71008.BB. Epub 2003 May 5. PMID: 12732600.
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  14. Annane D, Renault A, Brun-Buisson C, Megarbane B, Quenot JP, Siami S, Cariou A, Forceville X, Schwebel C, Martin C, Timsit JF, Misset B, Ali Benali M, Colin G, Souweine B, Asehnoune K, Mercier E, Chimot L, Charpentier C, François B, Boulain T, Petitpas F, Constantin JM, Dhonneur G, Baudin F, Combes A, Bohé J, Loriferne JF, Amathieu R, Cook F, Slama M, Leroy O, Capellier G, Dargent A, Hissem T, Maxime V, Bellissant E; CRICS-TRIGGERSEP Network. Hydrocortisone plus Fludrocortisone for Adults with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):809-818. doi: 10.1056/NEJMoa1705716. PMID: 29490185.
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  15. Venkatesh B, Finfer S, Cohen J, Rajbhandari D, Arabi Y, Bellomo R, Billot L, Correa M, Glass P, Harward M, Joyce C, Li Q, McArthur C, Perner A, Rhodes A, Thompson K, Webb S, Myburgh J; ADRENAL Trial Investigators and the Australian–New Zealand Intensive Care Society Clinical Trials Group. Adjunctive Glucocorticoid Therapy in Patients with Septic Shock. N Engl J Med. 2018 Mar 1;378(9):797-808. doi: 10.1056/NEJMoa1705835. Epub 2018 Jan 19. PMID: 29347874.
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  16. Russell JA, Walley KR, Gordon AC, Cooper DJ, Hébert PC, Singer J, Holmes CL, Mehta S, Granton JT, Storms MM, Cook DJ, Presneill JJ; Dieter Ayers for the Vasopressin and Septic Shock Trial Investigators. Interaction of vasopressin infusion, corticosteroid treatment, and mortality of septic shock. Crit Care Med. 2009 Mar;37(3):811-8. doi: 10.1097/CCM.0b013e3181961ace. PMID: 19237882.
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  17. Gordon AC, Mason AJ, Thirunavukkarasu N, Perkins GD, Cecconi M, Cepkova M, Pogson DG, Aya HD, Anjum A, Frazier GJ, Santhakumaran S, Ashby D, Brett SJ; VANISH Investigators. Effect of Early Vasopressin vs Norepinephrine on Kidney Failure in Patients With Septic Shock: The VANISH Randomized Clinical Trial. JAMA. 2016 Aug 2;316(5):509-18. doi: 10.1001/jama.2016.10485. PMID: 27483065.
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  18. Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Møller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. PMID: 34599691; PMCID: PMC8486643.
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  19. Hajjar LA, Zambolim C, Belletti A, de Almeida JP, Gordon AC, Oliveira G, Park CHL, Fukushima JT, Rizk SI, Szeles TF, Dos Santos Neto NC, Filho RK, Galas FRBG, Landoni G. Vasopressin Versus Norepinephrine for the Management of Septic Shock in Cancer Patients: The VANCS II Randomized Clinical Trial. Crit Care Med. 2019 Dec;47(12):1743-1750. doi: 10.1097/CCM.0000000000004023. PMID: 31609774.
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  20. Morales DL, Garrido MJ, Madigan JD, Helman DN, Faber J, Williams MR, Landry DW, Oz MC. A double-blind randomized trial: prophylactic vasopressin reduces hypotension after cardiopulmonary bypass. Ann Thorac Surg. 2003 Mar;75(3):926-30. doi: 10.1016/s0003-4975(02)04408-9. PMID: 12645718.
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  21. Garcia B, Legrand M. Adjunctive vasopressors in distributive shock: How soon is early? Crit Care. 2023 May 30;27(1):210. doi: 10.1186/s13054-023-04500-y. PMID: 37254175; PMCID: PMC10230760.
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  22. Stolk RF, van der Poll T, Angus DC, van der Hoeven JG, Pickkers P, Kox M. Potentially Inadvertent Immunomodulation: Norepinephrine Use in Sepsis. Am J Respir Crit Care Med. 2016 Sep 1;194(5):550-8. doi: 10.1164/rccm.201604-0862CP. PMID: 27398737.
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  23. Sacha GL, Lam SW, Wang L, Duggal A, Reddy AJ, Bauer SR. Association of Catecholamine Dose, Lactate, and Shock Duration at Vasopressin Initiation With Mortality in Patients With Septic Shock. Crit Care Med. 2022 Apr 1;50(4):614-623. doi: 10.1097/CCM.0000000000005317. PMID: 34582425.
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  24. Young PJ, Delaney A, Venkatesh B. Vasopressin in septic shock: what we know and where to next? Intensive Care Med. 2019 Jun;45(6):902-903. doi: 10.1007/s00134-019-05642-w. Epub 2019 May 13. PMID: 31087112.
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  25. Wallace AW, Tunin CM, Shoukas AA. Effects of vasopressin on pulmonary and systemic vascular mechanics. Am J Physiol. 1989 Oct;257(4 Pt 2):H1228-34. doi: 10.1152/ajpheart.1989.257.4.H1228. PMID: 2801982.
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  26. Evora PR, Pearson PJ, Schaff HV. Arginine vasopressin induces endothelium-dependent vasodilatation of the pulmonary artery. V1-receptor-mediated production of nitric oxide. Chest. 1993 Apr;103(4):1241-5. doi: 10.1378/chest.103.4.1241. PMID: 8131474.
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  27. Luckner G, Mayr VD, Jochberger S, Wenzel V, Ulmer H, Hasibeder WR, Dünser MW. Comparison of two dose regimens of arginine vasopressin in advanced vasodilatory shock. Crit Care Med. 2007 Oct;35(10):2280-5. doi: 10.1097/01.ccm.0000281853.50661.23. PMID: 17944015.
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  28. Currigan DA, Hughes RJ, Wright CE, Angus JA, Soeding PF. Vasoconstrictor responses to vasopressor agents in human pulmonary and radial arteries: an in vitro study. Anesthesiology. 2014 Nov;121(5):930-6. doi: 10.1097/ALN.0000000000000430. PMID: 25198173.
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  29. Tayama E, Ueda T, Shojima T, Akasu K, Oda T, Fukunaga S, Akashi H, Aoyagi S. Arginine vasopressin is an ideal drug after cardiac surgery for the management of low systemic vascular resistant hypotension concomitant with pulmonary hypertension. Interact Cardiovasc Thorac Surg. 2007 Dec;6(6):715-9. doi: 10.1510/icvts.2007.159624. Epub 2007 Aug 17. PMID: 17704123.
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  30. Jeon Y, Ryu JH, Lim YJ, Kim CS, Bahk JH, Yoon SZ, Choi JY. Comparative hemodynamic effects of vasopressin and norepinephrine after milrinone-induced hypotension in off-pump coronary artery bypass surgical patients. Eur J Cardiothorac Surg. 2006 Jun;29(6):952-6. doi: 10.1016/j.ejcts.2006.02.032. Epub 2006 May 3. PMID: 16675238.
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  31. Yimin H, Xiaoyu L, Yuping H, Weiyan L, Ning L. The effect of vasopressin on the hemodynamics in CABG patients. J Cardiothorac Surg. 2013 Mar 16;8:49. doi: 10.1186/1749-8090-8-49. PMID: 23497457; PMCID: PMC3610232.
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  32. Boyd JH, Holmes CL, Wang Y, Roberts H, Walley KR. Vasopressin decreases sepsis-induced pulmonary inflammation through the V2R. Resuscitation. 2008 Nov;79(2):325-31. doi: 10.1016/j.resuscitation.2008.07.006. PMID: 18951114.
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  33. Gordon AC, Russell JA, Walley KR, Singer J, Ayers D, Storms MM, Holmes CL, Hébert PC, Cooper DJ, Mehta S, Granton JT, Cook DJ, Presneill JJ. The effects of vasopressin on acute kidney injury in septic shock. Intensive Care Med. 2010 Jan;36(1):83-91. doi: 10.1007/s00134-009-1687-x. Epub 2009 Oct 20. PMID: 19841897.
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  34. Nagendran M, Russell JA, Walley KR, Brett SJ, Perkins GD, Hajjar L, Mason AJ, Ashby D, Gordon AC. Vasopressin in septic shock: an individual patient data meta-analysis of randomised controlled trials. Intensive Care Med. 2019 Jun;45(6):844-855. doi: 10.1007/s00134-019-05620-2. Epub 2019 May 6. PMID: 31062052.
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  35. Rydz AC, Elefritz JL, Conroy M, Disney KA, Miller CJ, Porter K, Doepker BA. EARLY INITIATION OF VASOPRESSIN REDUCES ORGAN FAILURE AND MORTALITY IN SEPTIC SHOCK. Shock. 2022 Oct 1;58(4):269-274. doi: 10.1097/SHK.0000000000001978. Epub 2022 Aug 16. PMID: 36018257.
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  36. Fox AW, May RE, Mitch WE. Comparison of peptide and nonpeptide receptor-mediated responses in rat tail artery. J Cardiovasc Pharmacol. 1992 Aug;20(2):282-9. doi: 10.1097/00005344-199208000-00014. PMID: 1381020.
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  37. Dunser MW, Wenzel V, Mayr AJ, Hasibeder WR. Management of vasodilatory shock: defining the role of arginine vasopressin. Drugs. 2003;63(3):237-56. doi: 10.2165/00003495-200363030-00001. PMID: 12534330.
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  38. Mutlu GM, Factor P. Role of vasopressin in the management of septic shock. Intensive Care Med. 2004 Jul;30(7):1276-91. doi: 10.1007/s00134-004-2283-8. Epub 2004 Apr 21. PMID: 15103461.
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  39. Turner DW, Attridge RL, Hughes DW. Vasopressin Associated With an Increase in Return of Spontaneous Circulation in Acidotic Cardiopulmonary Arrest Patients. Ann Pharmacother. 2014 Aug;48(8):986-991. doi: 10.1177/1060028014537037. Epub 2014 May 28. PMID: 24871568.
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  40. Bauer SR, Sacha GL, Siuba MT, Lam SW, Reddy AJ, Duggal A, Vachharajani V. Association of Arterial pH With Hemodynamic Response to Vasopressin in Patients With Septic Shock: An Observational Cohort Study. Crit Care Explor. 2022 Feb 8;4(2):e0634. doi: 10.1097/CCE.0000000000000634. PMID: 35156051; PMCID: PMC8826954.
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  41. Jaber S, Paugam C, Futier E, Lefrant JY, Lasocki S, Lescot T, Pottecher J, Demoule A, Ferrandière M, Asehnoune K, Dellamonica J, Velly L, Abback PS, de Jong A, Brunot V, Belafia F, Roquilly A, Chanques G, Muller L, Constantin JM, Bertet H, Klouche K, Molinari N, Jung B; BICAR-ICU Study Group. Sodium bicarbonate therapy for patients with severe metabolic acidaemia in the intensive care unit (BICAR-ICU): a multicentre, open-label, randomised controlled, phase 3 trial. Lancet. 2018 Jul 7;392(10141):31-40. doi: 10.1016/S0140-6736(18)31080-8. Epub 2018 Jun 14. Erratum in: Lancet. 2018 Dec 8;392(10163):2440. PMID: 29910040.
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  42. Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. Erratum in: Hepatology. 2017 Jul;66(1):304. PMID: 27786365.
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  43. Terés J, Planas R, Panes J, Salmeron JM, Mas A, Bosch J, Llorente C, Viver J, Feu F, Rodés J. Vasopressin/nitroglycerin infusion vs. esophageal tamponade in the treatment of acute variceal bleeding: a randomized controlled trial. Hepatology. 1990 Jun;11(6):964-8. doi: 10.1002/hep.1840110609. PMID: 2114350.
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  44. Jiang L, Sheng Y, Feng X, Wu J. The effects and safety of vasopressin receptor agonists in patients with septic shock: a meta-analysis and trial sequential analysis. Crit Care. 2019 Mar 14;23(1):91. doi: 10.1186/s13054-019-2362-4. PMID: 30871607; PMCID: PMC6419432.
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  45. Ferenchick H, Cemalovic N, Ferguson N, Dicpinigaitis PV. Diabetes Insipidus After Discontinuation of Vasopressin Infusion for Treatment of Shock. Crit Care Med. 2019 Dec;47(12):e1008-e1013. doi: 10.1097/CCM.0000000000004045. PMID: 31567344; PMCID: PMC7086483.
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  46. Link MS, Berkow LC, Kudenchuk PJ, Halperin HR, Hess EP, Moitra VK, Neumar RW, O’Neil BJ, Paxton JH, Silvers SM, White RD, Yannopoulos D, Donnino MW. Part 7: Adult Advanced Cardiovascular Life Support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S444-64. doi: 10.1161/CIR.0000000000000261. Erratum in: Circulation. 2015 Dec 15;132(24):e385. PMID: 26472995.
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  47. Yan W, Dong W, Song X, Zhou W, Chen Z. Therapeutic effects of vasopressin on cardiac arrest: a systematic review and meta-analysis. BMJ Open. 2023 Apr 17;13(4):e065061. doi: 10.1136/bmjopen-2022-065061. PMID: 37068900; PMCID: PMC10111914.
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  48. Mukoyama T, Kinoshita K, Nagao K, Tanjoh K. Reduced effectiveness of vasopressin in repeated doses for patients undergoing prolonged cardiopulmonary resuscitation. Resuscitation. 2009 Jul;80(7):755-61. doi: 10.1016/j.resuscitation.2009.04.005. Epub 2009 May 14. PMID: 19446387.
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  49. Andersen LW, Isbye D, Kjærgaard J, Kristensen CM, Darling S, Zwisler ST, Fisker S, Schmidt JC, Kirkegaard H, Grejs AM, Rossau JRG, Larsen JM, Rasmussen BS, Riddersholm S, Iversen K, Schultz M, Nielsen JL, Løfgren B, Lauridsen KG, Sølling C, Pælestik K, Kjærgaard AG, Due-Rasmussen D, Folke F, Charlot MG, Jepsen RMHG, Wiberg S, Donnino M, Kurth T, Høybye M, Sindberg B, Holmberg MJ, Granfeldt A. Effect of Vasopressin and Methylprednisolone vs Placebo on Return of Spontaneous Circulation in Patients With In-Hospital Cardiac Arrest: A Randomized Clinical Trial. JAMA. 2021 Oct 26;326(16):1586-1594. doi: 10.1001/jama.2021.16628. PMID: 34587236; PMCID: PMC8482303.
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  50. Holmberg MJ, Granfeldt A, Mentzelopoulos SD, Andersen LW. Vasopressin and glucocorticoids for in-hospital cardiac arrest: A systematic review and meta-analysis of individual participant data. Resuscitation. 2022 Feb;171:48-56. doi: 10.1016/j.resuscitation.2021.12.030. Epub 2022 Jan 3. Erratum in: Resuscitation. 2023 Sep;190:109929. PMID: 34990764.
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  51. Bauer SR, Sacha GL, Lam SW, Wang L, Reddy AJ, Duggal A, Vachharajani V. Hemodynamic Response to Vasopressin Dosage of 0.03 Units/Min vs. 0.04 Units/Min in Patients With Septic Shock. J Intensive Care Med. 2022 Jan;37(1):92-99. doi: 10.1177/0885066620977181. Epub 2020 Nov 28. PMID: 33251906; PMCID: PMC10243460.
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  52. Lauzier F, Lévy B, Lamarre P, Lesur O. Vasopressin or norepinephrine in early hyperdynamic septic shock: a randomized clinical trial. Intensive Care Med. 2006 Nov;32(11):1782-9. doi: 10.1007/s00134-006-0378-0. Epub 2006 Sep 22. PMID: 17019548.
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  53. Hammond DA, Sacha GL, Bissell BD, et al: Effects of norepinephrine and vasopressin discontinuation order in the recovery phase of septic shock: A systematic review and individual patient data meta-analysis. Pharmacotherapy 2019; 39:544–552
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  54. Wu Z, Zhang S, Xu J, Xie J, Huang L, Huang Y, Yang Y, Qiu H. Norepinephrine vs Vasopressin: Which Vasopressor Should Be Discontinued First in Septic Shock? A Meta-Analysis. Shock. 2020 Jan;53(1):50-57. doi: 10.1097/SHK.0000000000001345. PMID: 31008869.
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  55. Lam SW, Sacha GL, Duggal A, Reddy AJ, Bauer SR. Abrupt Discontinuation Versus Down-Titration of Vasopressin in Patients Recovering from Septic Shock. Shock. 2021 Feb 1;55(2):210-214. doi: 10.1097/SHK.0000000000001609. PMID: 32842024.
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  56. Caldwell HK, Lee HJ, Macbeth AH, Young WS 3rd. Vasopressin: behavioral roles of an “original” neuropeptide. Prog Neurobiol. 2008 Jan;84(1):1-24. doi: 10.1016/j.pneurobio.2007.10.007. Epub 2007 Nov 4. PMID: 18053631; PMCID: PMC2292122.
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  57. Shampo MA, Kyle RA, Steensma DP. Stamp vignette on medical science. Vincent du Vigneaud-Nobel Prize in chemistry. Mayo Clin Proc. 2013 Sep;88(9):e99. doi: 10.1016/j.mayocp.2012.01.032. PMID: 24001505.
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  58. Glavaš M, Gitlin-Domagalska A, Dębowski D, Ptaszyńska N, Łęgowska A, Rolka K. Vasopressin and Its Analogues: From Natural Hormones to Multitasking Peptides. Int J Mol Sci. 2022 Mar 12;23(6):3068. doi: 10.3390/ijms23063068. PMID: 35328489; PMCID: PMC8955888.
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  59. Bendicksen L, Kesselheim AS, Rome BN. The Vexing Voyage of Vasopressin: The Consequences of Granting Market Exclusivity to Unapproved Drugs. Chest. 2022 Aug;162(2):433-435. doi: 10.1016/j.chest.2022.02.048. PMID: 35940656; PMCID: PMC9353103.
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  60. Russell JA, Fjell C, Hsu JL, Lee T, Boyd J, Thair S, Singer J, Patterson AJ, Walley KR. Vasopressin compared with norepinephrine augments the decline of plasma cytokine levels in septic shock. Am J Respir Crit Care Med. 2013 Aug 1;188(3):356-64. doi: 10.1164/rccm.201302-0355OC. PMID: 23796235.
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    Vasopressin Injection, USP.” FDA.gov, U.S. Food and Drug Administration, 2023, https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204485s003lbl.pdf.