Treatment of severe systemic inflammatory response syndrome and sepsis with a novel bradykinin antagonist, deltibant (CP-0127): Results of a randomized, double-blind, placebo-controlled trial

JAMA

Volumn 277, Issue 6, 1997, Pages 482-487

  Fein, Alan M ^a   Bernard, Gordon R ^b   Criner, Gerard J ^c   Fletcher, Eugene C ^d,e   Good, James T ^f   Knaus, William A ^g   Levy, Howard ^h   Matuschak, George M ⁱ   Shanies, Harvey M ^j   Taylor, Robert W ^k   Rodell, Timothy C ^l  

^a WINTHROP UNIVERSITY HOSPITAL   (United States)

^b VANDERBILT UNIVERSITY   (United States)

^c TEMPLE UNIVERSITY HOSPITAL   (United States)

^d MICHAEL E DEBAKEY VETERANS AFFAIRS MEDICAL CENTER   (United States)

^e UNIVERSITY OF LOUISVILLE HOSPITAL   (United States)

^f Porter Hospital   (United States)

^g GEORGE WASHINGTON UNIVERSITY   (United States)

^h UNIVERSITY OF NEW MEXICO   (United States)

ⁱ S LOUIS UNIV HLTH SCIENCES CENTER   (United States)

^j ELMHURST HOSPITAL CENTER   (United States)

^k ST JOHN S MERCY MEDICAL CENTER   (United States)

^l Departments of New Leads Chemistry and Pharmacology   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BRADYKININ ANTAGONIST; DELTIBANT; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; GRAM NEGATIVE INFECTION; HUMAN; HYPOTENSION; INFLAMMATION; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MORTALITY; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEPSIS; SURVIVAL; SYSTEMIC INFLAMMATORY RESPONSE SYNDROME; TREATMENT OUTCOME;

EID: 0008021312     PISSN: 00987484     EISSN: None     Source Type: Journal    
DOI: 10.1001/jama.277.6.482     Document Type: Article

References (27)

1. Panillo JE, moderator. Proceedings from a National Institutes of Health conference: septic shock in humans: advances in the understanding of pathogenesis, cardiovascular dysfunction, and therapy. Ann Intern Mad. 1990;113:227-242.
2. Bone RC, Balk RA, Cerra FB, et al. Proceedings from an American College of Chest Physicians-Society of Critical Care Medicine consensus conference: definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. Chest. 1992;101:1644-1655.
3. Dhainaut J-FA, Vincent J-L, Richard C, et al. CDP571, a humanized antibody to human tumor necrosis factor safety, pharmacokinetics, immune response, and influence of the antibody on cytokine concentrations in patients with septic shock. Crit Care Med. 1995;23:1461-1469.
4. Ziegler EJ, Fisher CJ Jr, Sprung CL, et al. Treatment of gram-negative bacteremia and septic shock with HA-1A human monoclonal antibody against endotoxin: a randomized, double-blind, placebo-controlled trial. N Engl J Med. 1991;324:429-436.
5. Fisher CJ Jr, Slotman GJ, Opal SM, et al. Initial evaluation of human recombinant interleukin-1 receptor antagonist in the treatment of sepsis syndrome: a randomized, open-label, placebo-controlled multicenter trial. Crit Care Med. 1994;22:12-21.
6. Fisher CJ Jr, Dhainaut J-FA, Opal SM, et al. Recombinant human interleukin 1 receptor antagonist in the treatment of patients with sepsis syndrome. JAMA. 1994;271:1836-1843. Correction. JAMA. 1994;272:1170.
7. Fisher CJ Jr, Dhainaut J-FA, Opal SM, et al. Recombinant human interleukin 1 receptor antagonist in the treatment of patients with sepsis syndrome. JAMA. 1994;271:1836-1843. Correction. JAMA. 1994;272:1170.
8. McCloskey RV, Straube RC, Sanders C, Smith SM, Smith CR, the CHESS Trial Study Group. Treatment of septic shock with human monoclonal antibody HA-1A. Ann Intern Med. 1994;121:1-5.
9. Bhoola KD, Figueroa CD, Worthy K. Bioregulation of kinins: kallikreins, kininogens, and kininases. Pharmacol Rev. 1992;44:1-80.
10. Figueroa CD, Henderson LM, Kaufmann J, et al. Immunovisualization of high (HK) and low (LK) molecular weight kininogens on isolated human neutrophils. Blood. 1992;79:754-759.
11. Christopher TA, Ma X-L, Gauthier TW, Lefer AM. Beneficial actions of CP-0127, a novel bradykinin receptor antagonist, in murine traumatic shock. Am J Physiol. 1994;266:H867-H873.
12. Cheronis JC, Whalley ET, Nguyen KT, et al. A new class of bradykinin antagonists: synthesis and in vitro activity of bissuccinimidoalkane peptide dimers. J Med Chem. 1992;35:1563-1572.
13. Whalley ET, Solomon JA, Modafferi DM, Bonham KA, Cheronis JC. CP-0127, a novel potent bradykinin antagonist, increases survival in rat and rabbit models of endotoxin shock. AAS. 1992;38:413-420.
14. Fisher CJ Jr, Opal SM, Dhainaut J-FA, et al. Influence of an anti-tumor necrosis factor monoclonal antibody on cytokine levels in patients with sepsis. Crit Care Med. 1993;21:318-327.
15. Knaus WA, Harrell FE, Fisher CJ Jr, et al. The clinical evaluation of new drugs for sepsis: a prospective study design based on survival analysis. JAMA. 1993;270:1233-1241.
16. Goldie AS, Fearon KCH, Ross JA, et al. Natural cytokine antagonists and endogenous anti-endotoxin core antibodies in sepsis syndrome. JAMA. 1995;274:172-177.
17. Aasen AO, Smith-Erichsen N, Amundsen E. Plasma kallikrein-kinin system in septicemia. Arch Surg. 1983;118:343-346.
18. Hirsch EF, Nakajima T, Oshima G, Erdös EG, Herman CM. Kinin system responses in sepsis after trauma in man. J Surg Res. 1974;17:147-153.
19. Ridings PC, Sugerman HJ, Blocher CR, Fisher BJ, Fowler AA. Hemodynamic effects of bradykinin antagonism in porcine gram-negative sepsis. J Invest Surg. 1995;8:115-122.
20. Guerrero R, Velasco F, Rodriguez M, et al. Endotoxin-induced pulmonary dysfunction is prevented by C1-esterase inhibitor. J Clin Invest. 1993; 91:2754-2760.
21. De La Cadena RA, Suffredini AF, Page JD, et al. Activation of the kallikrein-kinin system after endotoxin administration to normal human volunteers. Blood. 1993;81:3313-3317.
22. Carvalho AC, DeMarinis S, Scott CF, Silver LD, Schmaier AH, Colman RW. Activation of the contact system of plasma proteolysis in the adult respiratory distress syndrome. J Lab Clin Med. 1988;112:270-277.
23. Tiffany CW, Burch RM. Bradykinin stimulates tumor necrosis factor and interleukin-1 release from macrophages. FEBS Lett. 1989;247:189-192.
24. Noronha-Blob L, Presser JC, Lowe VC, et al. NPC 17731 delays the onset of hypotension and reduces mortality in response to lethal doses of endotoxin in rats and mice. Presented at the International Conference, Kinin '91; September 8-14, 1991; Munich, Germany.
25. Knaus WA, Wagner DP, Sun X, Harrell FE Jr, Hedstrom JS. Risk assessment in recent clinical trials in sepsis/SIRS: lessons learned and future directions. J Endotoxin Res. 1995;2:169-175.
26. Maeda H, Akaike T, Sakata Y, Maruo K. Role of bradykinin in microbial infection: enhancement of septicemia by microbial proteases and kinin. AAS. 1993;42:159-165.
27. Dhainaut J-FA, Mira J-P, Fiérobe L. Platelet-activating factor: pathophysiological changes and therapeutic implications in sepsis. Update Intensive Care Emerg Med. 1994;18:397-413.