Low-dose steroids for septic shock and severe sepsis: The use of Bayesian statistics to resolve clinical trial controversies

Intensive Care Medicine

Volumn 37, Issue 3, 2011, Pages 420-429

  Kalil, Andre C ^a   Sun, Junfeng ^b  

^a UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^b NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

Sepsis; Shock; Steroids

Indexed keywords

DEXAMETHASONE; FLUDROCORTISONE; HYDROCORTISONE; METHYLPREDNISOLONE; PREDNISOLONE; STEROID;

BAYES THEOREM; DISEASE SEVERITY; DRUG SAFETY; GASTROINTESTINAL HEMORRHAGE; HUMAN; HYPERGLYCEMIA; LOW DRUG DOSE; META ANALYSIS; META ANALYSIS (TOPIC); MORTALITY; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RISK REDUCTION; SEPSIS; SEPTIC SHOCK; SUPERINFECTION; TREATMENT OUTCOME;

BAYES THEOREM; CLINICAL TRIALS AS TOPIC; HUMANS; META-ANALYSIS AS TOPIC; ODDS RATIO; OUTCOME ASSESSMENT (HEALTH CARE); RANDOMIZED CONTROLLED TRIALS AS TOPIC; REPRODUCIBILITY OF RESULTS; RISK ASSESSMENT; SEVERITY OF ILLNESS INDEX; SHOCK, SEPTIC; STEROIDS; UNITED STATES;

EID: 79953826862     PISSN: 03424642     EISSN: 14321238     Source Type: Journal    
DOI: 10.1007/s00134-010-2121-0     Document Type: Review

References (47)

1. Schumer W (1976) Steroids in the treatment of clinical septic shock. Ann Surg 184:333-341
2. Sprung CL, Caralis PV, Marcial EH, Pierce M, Gelbard MA, Long WM, Duncan RC, Tendler MD, Karpf M (1984) The effects of high-dose corticosteroids in patients with septic shock. A prospective, controlled study. N Engl J Med 311:1137-1143 (Pubitemid 14012580)
3. The Veterans Administration Systemic Sepsis Cooperative Study Group (1987) Effect of high-dose glucocorticoid therapy on mortality in patients with clinical signs of systemic sepsis. N Engl J Med 317:659-665
4. Cronin L, Cook DJ, Carlet J, Heyland DK, King D, Lansang MA, Fisher CJ Jr (1995) Corticosteroid treatment for sepsis: a critical appraisal and meta-analysis of the literature. Crit Care Med 23:1430-1439
5. Bollaert PE, Charpentier C, Levy B, Debouverie M, Audibert G, Larcan A (1998) Reversal of late septic shock with supraphysiologic doses of hydrocortisone. Crit Care Med 26:645-650 (Pubitemid 28201409)
6. Briegel J, Forst H, Haller M, Schelling G, Kilger E, Kuprat G, Hemmer B, Hummel T, Lenhart A, Heyduck M, Stoll C, Peter K (1999) Stress doses of hydrocortisone reverse hyperdynamic septic shock: a prospective, randomized, double-blind, single-center study. Crit Care Med 27:723-732 (Pubitemid 29218204)
7. Chawla K, Kupfer Y, Goldman I, Tessler S (1999) Hydrocortisone reverses refractory septic shock. Crit Care Med 27(1):A33
8. Yildiz O, Doganay M, Aygen B, Guven M, Kelestimur F, Tutuu A (2002) Physiological-dose steroid therapy in sepsis [ISRCTN36253388]. Crit Care 6:251-259
9. Oppert M, Schindler R, Husung C, Offermann K, Gräf KJ, Boenisch O, Barckow D, Frei U, Eckardt KU (2005) Low-dose hydrocortisone improves shock reversal and reduces cytokine levels in early hyperdynamic septic shock. Crit Care Med 33:2457-2464 (Pubitemid 41682095)
10. Annane D, Sébille V, Charpentier C, Bollaert PE, François B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troché G, Chaumet-Riffaud P, Bellissant E (2002) Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA 288:862-871
11. Sprung CL, Annane D, Keh D, Moreno R, Singer M, Freivogel K, Weiss YG, Benbenishty J, Kalenka A, Forst H, Laterre PF, Reinhart K, Cuthbertson BH, Payen D, Briegel J, CORTICUS Study Group (2008) Hydrocortisone therapy for patients with septic shock. N Engl J Med 358:111-124
12. Minneci PC, Deans KJ, Eichacker PQ, Natanson C (2009) The effects of steroids during sepsis depend on dose and severity of illness: an updated meta-analysis. Clin Microbiol Infect 15:308-318
13. Annane D, Bellissant E, Bollaert PE, Briegel J, Confalonieri M, De Gaudio R, Keh D, Kupfer Y, Oppert M, Meduri GU (2009) Corticosteroids in the treatment of severe sepsis and septic shock in adults: a systematic review. JAMA 301:2362-2375
14. Marik PE, Pastores SM, Annane D, Meduri GU, Sprung CL, Arlt W, Keh D, Briegel J, Beishuizen A, Dimopoulou I, Tsagarakis S, Singer M, Chrousos GP, Zaloga G, Bokhari F, Vogeser M, American College of Critical Care Medicine (2008) Recommendations for the diagnosis and management of corticosteroid insufficiency in critically ill adult patients: consensus statements from an international task force by the American College of Critical Care Medicine. Crit Care Med 36:1937-1949
15. Bernard GR, Vincent JL, Laterre PF, LaRosa SP, Dhainaut JF, Lopez-Rodriguez A, Steingrub JS, Garber GE, Helterbrand JD, Ely EW, Fisher CJ Jr, Recombinant Human Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) Study Group (2001) Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med 344:699-709 (Pubitemid 32204987)
16. Annane D, Trabold F, Sharshar T, Jarrin I, Blanc AS, Raphael JC, Gajdos P (1999) Inappropriate sympathetic activation at onset of septic shock: a spectral analysis approach. Am J Respir Crit Care Med 160:458-465 (Pubitemid 29380658)
17. Center for Drug Evaluation and Research (CDER) (2005) Reviewer guidance on conducting a clinical safety review of a new product application and preparing a report on the review. US FDA, Rockville, MD
18. Mantel N, Haenszel W (1959) Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 22:719-748
19. DerSimonian R, Laird N (1986) Meta-analysis in clinical trials. Control Clin Trials 7:177-188 (Pubitemid 17189972)
20. Spiegelhalter DJ, Myles JP, Jones DR, Abrams KR (2000) Bayesian methods in health technology assessment: a review. Health Technol Assess 4:1-130
21. Kalil AC, Sun J (2008) Why are clinicians not embracing the results from pivotal clinical trials in severe sepsis? A Bayesian analysis. PLoS One 3:e2291
22. Kalil AC, Sun J (2008) How many patients with severe sepsis are needed to confirm the efficacy of drotrecogin alfa activated? A Bayesian design. Intensive Care Med 34:1804-1811
23. Spiegelhatler DJ, Abrams KR, Myles JP (eds) (2004) Bayesian approaches to clinical trials and health-care evaluation. Wiley,West Sussex, p 170
24. Meduri GU, Golden E, Freire AX, Taylor E, Zaman M, Carson SJ, Gibson M, Umberger R (2007) Methylprednisolone infusion in early severe ARDS: results of a randomized controlled trial. Chest 131:954-963 (Pubitemid 46608692)
25. Mussack T, Briegel J, Schelling G, Biberthaler P, Jochum M (2005) Effect of stress doses of hydrocortisone on S-100B vs. interleukin-8 and polymorphonuclear elastase levels in human septic shock. Clin Chem Lab Med 43:259-268
26. Luboshitzky R, Qupti G (2008) Corticosteroids for septic shock. N Engl J Med 358:2069, author reply 2070-2071
27. Dellinger RP (2008) Steroid therapy of septic shock: the decision is in the eye of the beholder. Crit Care Med 36:1987-1989
28. Moraes RB, Czepielewski MA, Friedman G (2009) Is the cortrosyn test necessary in high basal corticoid patients with septic shock? Crit Care Med 37:385-386, author reply 386-387
29. Salluh JI, Soares M (2008) New recommendations for the use of corticosteroids in sepsis: not so fast! Crit Care Med 36:2489-2490, author reply 2490
30. Lamontagne F, Meade MO (2008) Low-dose hydrocortisone did not improve survival in patients with septic shock but reversed shock earlier. ACP J Club 148:6
31. Seam N (2008) Corticosteroids for septic shock. N Engl J Med 358:2068-2069, author reply 2070-2071
32. Daley MR (2008) Corticosteroids for septic shock. N Engl J Med 358:2068, author reply 2070-2071
33. Eichacker PQ, Parent C, Kalil A, Esposito C, Cui X, Banks SM, Gerstenberger EP, Fitz Y, Danner RL, Natanson C (2002) Risk and the efficacy of antiinflammatory agents: retrospective and confirmatory studies of sepsis. Am J Respir Crit Care Med 166:1197-1205 (Pubitemid 35222596)
34. Li Y, Cui X, Li X, Solomon SB, Danner RL, Banks SM, Fitz Y, Annane D, Natanson C, Eichacker PQ (2008) Risk of death does not alter the efficacy of hydrocortisone therapy in a mouse E. coli pneumonia model: risk and corticosteroids in sepsis. Intensive Care Med 34:568-577 (Pubitemid 351623024)
35. Ferrer R, Artigas A, Suarez D, Palencia E, Levy MM, Arenzana A, Pérez XL, Sirvent JM, Edusepsis Study Group (2009) Effectiveness of treatments for severe sepsis: a prospective, multicenter, observational study. Am J Respir Crit Care Med 180:861-866
36. Levy MM, Dellinger RP, Townsend SR, Linde-Zwirble WT, Marshall JC, Bion J, Schorr C, Artigas A, Ramsay G, Beale R, Parker MM, Gerlach H, Reinhart K, Silva E, Harvey M, Regan S, Angus DC (2010) The Surviving Sepsis Campaign: results of an international guideline-based performance improvement program targeting severe sepsis. Intensive Care Med 36:222-231
37. Bagshaw SM, Egi M, George C, Bellomo R, for the ANZICS Database Management Committee (2009) Early blood glucose control and mortality in critically ill patients in Australia. Crit Care Med 37:463-470
38. Petros A, Bennett D, Vallance P (1991) Effect of nitric oxide synthase inhibitors on hypotension in patients with septic shock. Lancet 338:1557-1558
39. Lorente JA, Landin L, De Pablo R, Renes E, Liste D (1993) L-arginine pathway in the sepsis syndrome. Crit Care Med 21:1287-1295 (Pubitemid 23270497)
40. Petros A, Lamb G, Leone A, Moncada S, Bennett D, Vallance P (1994) Effects of a nitric oxide synthase inhibitor in humans with septic shock. Cardiovasc Res 28:34-39
41. Bakker J, Grover R, McLuckie A, Holzapfel L, Andersson J, Lodato R, Watson D, Grossman S, Donaldson J, Takala J, Glaxo Wellcome International Septic Shock Study Group (2004) Administration of the nitric oxide synthase inhibitor NG-methyl-L-arginine hydrochloride (546C88) by intravenous infusion for up to 72 hours can promote the resolution of shock in patients with severe sepsis: results of a randomized, double-blind, placebo-controlled multicenter study (study no. 144-002). Crit Care Med 32:1-12
42. López A, Lorente JA, Steingrub J, Bakker J, McLuckie A, Willatts S, Brockway M, Anzueto A, Holzapfel L, Breen D, Silverman MS, Takala J, Donaldson J, Arneson C, Grove G, Grossman S, Grover R (2004) Multiple-center, randomized, placebo-controlled, double-blind study of the nitric oxide synthase inhibitor 546C88: effect on survival in patients with septic shock. Crit Care Med 32:21-30 (Pubitemid 38125559)
43. Moraes RB, Czepielewski MA (2009) Corticosteroid therapy for severe sepsis and septic shock. JAMA 302:1643-1644, author reply 1644-1645
44. Confalonieri M, Urbino R, Potena A, Piattella M, Parigi P, Puccio G, Della Porta R, Giorgio C, Blasi F, Umberger R, Meduri GU (2005) Hydrocortisone infusion for severe community-acquired pneumonia: a preliminary randomized study. Am J Respir Crit Care Med 171:242-248
45. Tandan SM, Guleria R, Gupta N (2005) Low dose steroids and adrenocortical insufficiency in septic shock: a double-blind randomised controlled trial from India. Am J Respir Crit Care Med 171:A24
46. Rinaldi S, Adembri C, Grechi S, De Gaudio AR (2006) Low-dose hydrocortisone during severe sepsis: effects on microalbuminuria. Crit Care Med 34:2334-2339 (Pubitemid 44260017)
47. Cicarelli DD, Bensenor FE, Vieira JE (2006) Effects of single dose of dexamethasone on patients with systemic inflammatory response. Sao Paulo Med J 124:90-95 (Pubitemid 44194360)