Control groups in recent septic shock trials: a systematic review

Intensive Care Medicine

Volumn 42, Issue 12, 2016, Pages 1912-1921

  Pettilä, Ville ^a,b   Hjortrup, Peter Buhl ^c   Jakob, Stephan M ^a   Wilkman, Erika ^b   Perner, Anders ^c,d   Takala, Jukka ^a  

^a UNIVERSITY OF BERN   (Switzerland)

^b HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^c University of Copenhagen   (Denmark)

^d Center of Research for Intensive Care   (Denmark)

Author keywords

Control group; Randomized; Reporting; Septic shock; Standardization; Trial

Indexed keywords

HYPERTENSIVE FACTOR; LACTIC ACID; NORADRENALIN;

ADULT DISEASE; ARTIFICIAL VENTILATION; CONTROL GROUP; ERYTHROCYTE TRANSFUSION; HEMODYNAMICS; HUMAN; INFECTION; LACTATE BLOOD LEVEL; MEAN ARTERIAL PRESSURE; MORTALITY; OUTCOME ASSESSMENT; PARALLEL DESIGN; RANDOMIZED CONTROLLED TRIAL (TOPIC); RENAL REPLACEMENT THERAPY; REVIEW; SAMPLE SIZE; SEPTIC SHOCK; SEQUENTIAL ORGAN FAILURE ASSESSMENT SCORE; SYSTEMATIC REVIEW; MEDICAL RESEARCH; SHOCK, SEPTIC; STANDARDS;

BIOMEDICAL RESEARCH; CONTROL GROUPS; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); RANDOMIZED CONTROLLED TRIALS AS TOPIC; SHOCK, SEPTIC;

EID: 84979608705     PISSN: 03424642     EISSN: 14321238     Source Type: Journal    
DOI: 10.1007/s00134-016-4444-y     Document Type: Review

References (37)

1. Shankar-Hari M, Phillips GS, Levy ML et al (2016) Developing a new definition and assessing new clinical criteria for septic shock: for the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA 315:775–787
2. Deans KJ, Minneci PC, Suffredini AF et al (2007) Randomization in clinical trials of titrated therapies: unintended consequences of using fixed treatment protocols. Crit Care Med 35:1509–1516
3. Takala J (2009) Better conduct of clinical trials: the control group in critical care trials. Crit Care Med 37(1 Suppl):S80–S90
4. Investigators PROCESS, Yealy DM, Kellum JA et al (2014) A randomized trial of protocol-based care for early septic shock. N Engl J Med 370:1683–1693
5. ARISE Investigators, ANZICS Clinical Trials Group, Peake S et al (2014) Goal-directed resuscitation for patients with early septic shock. N Engl J Med 371:1496–1506
6. Mouncey PR, Osborn T, Power GS, Trial Investigators PROMISE et al (2015) Trial of early, goal-directed resuscitation for septic shock. N Engl J Med 372:1301–1311
7. Caironi P, Tognoni G, Masson S, Albios Study Investigators et al (2014) Albumin replacement in patients with severe sepsis or septic shock. N Engl J Med 370:1412–1421
8. De Backer D, Biston P, Devriendt J et al (2010) Comparison of dopamine and norepinephrine in the treatment of shock. N Engl J Med 362:779–789
9. Brunkhorst FM, Oppert M, Marx G et al (2012) Effect of empirical treatment with moxifloxacin and meropenem vs. meropenem on sepsis-related organ dysfunction in patients with severe sepsis: a randomized trial. JAMA 307:2390–2399
10. Vincent JL, Marshall JC, Dellinger RP et al (2015) Talactoferrin in severe sepsis: results from the phase II/III Oral tAlactoferrin in Severe sepsIS Trial. Crit Care Med 43:1832–1838
11. Lin SM, Huang CD, Lin HC, Liu CY, Wang CH, Kuo HP (2006) A modified goal-directed protocol improves clinical outcomes in intensive care unit patients with septic shock: a randomized controlled trial. Shock 26:551–557
12. Annane D, Vignon P, Renault A et al (2007) Norepinephrine plus dobutamine versus epinephrine alone for management of septic shock: a randomised trial. Lancet 370:676–684
13. Werdan K, Pilz G, Bujdoso O et al (2007) Score-based immunoglobulin G therapy of patients with sepsis: the SBITS study. Crit Care Med 35:2693–2701
14. Sprung CL, Annane D, Keh D et al (2008) Hydrocortisone therapy for patients with septic shock. N Engl J Med 358:111–124
15. Stephens DP, Thomas JH, Higgins A et al (2008) Randomized, double-blind, placebo-controlled trial of granulocyte colony-stimulating factor in patients with septic shock. Crit Care Med 36:448–454
16. Russell JA, Walley KR, Singer J et al (2008) Vasopressin versus norepinephrine infusion in patients with septic shock. N Engl J Med 358:877–887
17. Dhainaut JF, Antonelli M, Wright P et al (2009) Extended drotrecogin alfa (activated) treatment in patients with prolonged septic shock. Intensive Care Med 35:1187–1195
18. Palizas F, Dubin A, Regueira T et al (2009) Gastric tonometry versus cardiac index as resuscitation goals in septic shock: a multicenter, randomized, controlled trial. Crit Care 13:R44
19. Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA (2010) Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA 303:739–746
20. Patel GP, Grahe JS, Sperry M et al (2010) Efficacy and safety of dopamine versus norepinephrine in the management of septic shock. Shock 33:375–380
21. Annane D, Cariou A, Maxime V et al (2010) Corticosteroid treatment and intensive insulin therapy for septic shock in adults: a randomized controlled trial. JAMA 303:341–348
22. Huh JW, Choi HS, Lim CM et al (2011) Low-dose hydrocortisone treatment for patients with septic shock: a pilot study comparing 3 days with 7 days. Respirology 16:1088–1095
23. Ranieri VM, Thompson BT, Barie BS, PROWESS-SHOCK study group et al (2012) Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med 366:2055–2064
24. Perner A, Haase N, Guttormsen AB, Scandinavian Critical Care Trials Group (2012) Hydroxyethyl starch 130/0.42 versus Ringer’s acetate in severe sepsis. N Engl J Med 367:124–134
25. Schortgen F, Clabault K, Katsahian S et al (2012) Fever control using external cooling in septic shock: a randomized controlled trial. Am J Respir Crit Care Med 185:1088–1095
26. Annane D, Timsit JF, Megarbane B et al (2013) Recombinant human activated protein C for adults with septic shock: a randomized controlled trial. Am J Respir Crit Care Med 187:1091–1097
27. Joannes-Boyau O, Honore PM, Perez P et al (2013) High-volume versus standard-volume haemofiltration for septic shock patients with acute kidney injury (IVOIRE study): a multicentre randomized controlled trial. Intensive Care Med 39:1535–1546
28. Holst LB, Haase N, Wetterslev J, TRISS trial group, Scandinavian Critical Care Trials Group et al (2014) Lower versus higher hemoglobin threshold for transfusion in septic shock. N Engl J Med 371:1381–1391
29. Asfar P, Meziani F, Hamel JF, Investigators Sepsispam et al (2014) High versus low blood-pressure target in patients with septic shock. N Engl J Med 370:1583–1593
30. Lu NF, Zheng RQ, Lin H, Shao J, Yu JQ, Yang DG (2015) Improved sepsis bundles in the treatment of septic shock: a prospective clinical study. Am J Emerg Med 33:1045–1049
31. Payen DM, Guilhot J, Launey Y et al (2015) Early use of polymyxin B hemoperfusion in patients with septic shock due to peritonitis: a multicenter randomized control trial. Intensive Care Med 41:975–984
32. Singer M, Deutschman CS, Seymour CW et al (2016) The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA 315:801–810
33. Kavanagh BP, Nurok M (2015) Standardized intensive care—protocol misalignment and impact misattribution. Am J Respir Crit Care Med 193:17–22
34. Porter ME, Larsson S, Lee TH (2016) Standardizing patient outcomes measurement. N Engl J Med 374:504–506
35. Myles PS, Grocott MP, Boney O, Moonesinghe SR, COMPAC-StEP Group (2016) Standardizing end points in perioperative trials: towards a core and extended outcome set. Br J Anaesth 116:586–589
36. Schulz KF, Altman DG, Moher D, For the CONSORT group (2010) CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. J Clin Epidem 63:834–840
37. Annane D (2009) Improving clinical trials in the critically ill: unique challenge—sepsis. Crit Care Med 37:S117–S128