Restricting volumes of resuscitation fluid in adults with septic shock after initial management: the CLASSIC randomised, parallel-group, multicentre feasibility trial

Intensive Care Medicine

Volumn 42, Issue 11, 2016, Pages 1695-1705

  Hjortrup, Peter B ^a   Haase, Nicolai ^a   Bundgaard, Helle ^b   Thomsen, Simon L ^c   Winding, Robert ^d   Pettilä, Ville ^e   Aaen, Anne ^f   Lodahl, David ^g   Berthelsen, Rasmus E ^h   Christensen, Henrik ⁱ   Madsen, Martin B ^a   Winkel, Per ^a   Wetterslev, Jørn ^a   Perner, Anders ^a,j   The CLASSIC Trial Group, ^k   The Scandinavian Critical Care Trials Group, ^k  

^a Rigshospitalet   (Denmark)

^b RANDERS REGIONAL HOSPITAL   (Denmark)

^c AALBORG UNIVERSITY HOSPITAL   (Denmark)

^d HERNING HOSPITAL   (Denmark)

^e HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

^f HOLBÆK HOSPITAL   (Denmark)

^g HOLSTEBRO HOSPITAL   (Denmark)

^h HILLERØD HOSPITAL   (Denmark)

ⁱ GENTOFTE UNIVERSITY HOSPITAL   (Denmark)

^j Centre for Research in Intensive Care   (Denmark)

^k NONE

more..

Author keywords

Critical care; Fluid therapy; Intensive care; Resuscitation; Sepsis; Septic; Shock

Indexed keywords

CREATININE; LACTIC ACID; NORADRENALIN; POTASSIUM; SODIUM;

ADULT; AGED; ARTICLE; ARTIFICIAL VENTILATION; CLINICAL PROTOCOL; CONTROLLED STUDY; FEMALE; FLUID RESUSCITATION; HEART STROKE VOLUME; HUMAN; INTENSIVE CARE UNIT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OLIGURIA; OUTCOME ASSESSMENT; PERFUSION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEPTIC SHOCK; SYSTOLIC BLOOD PRESSURE; ADVERSE EFFECTS; CIRCULATION; CLINICAL TRIAL; ELECTROLYTE BALANCE; FEASIBILITY STUDY; FLUID THERAPY; INTENSIVE CARE; MIDDLE AGED; ODDS RATIO; PATHOPHYSIOLOGY; PHYSIOLOGY; PROCEDURES; RESUSCITATION; SHOCK, SEPTIC; STATISTICS AND NUMERICAL DATA;

AGED; BLOOD CIRCULATION; CRITICAL CARE; FEASIBILITY STUDIES; FEMALE; FLUID THERAPY; HUMANS; INTENSIVE CARE UNITS; MALE; MIDDLE AGED; ODDS RATIO; RESUSCITATION; SHOCK, SEPTIC; WATER-ELECTROLYTE BALANCE;

EID: 84989183224     PISSN: 03424642     EISSN: 14321238     Source Type: Journal    
DOI: 10.1007/s00134-016-4500-7     Document Type: Article

References (25)

1. Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb S, Beale RJ, Vincent JL, Moreno R (2013) Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med 39:165–228
2. Boyd JH, Forbes J, Nakada TA, Walley KR, Russell JA (2011) Fluid resuscitation in septic shock: a positive fluid balance and elevated central venous pressure are associated with increased mortality. Crit Care Med 39:259–265
3. Acheampong A, Vincent JL (2015) A positive fluid balance is an independent prognostic factor in patients with sepsis. Crit Care 19:251
4. Maitland K, Kiguli S, Opoka RO, Engoru C, Olupot-Olupot P, Akech SO, Nyeko R, Mtove G, Reyburn H, Lang T, Brent B, Evans JA, Tibenderana JK, Crawley J, Russell EC, Levin M, Babiker AG, Gibb DM (2011) Mortality after fluid bolus in African children with severe infection. N Engl J Med 364:2483–2495
5. Hjortrup PB, Haase N, Wetterslev J, Perner A (2016) Associations of hospital and patient characteristics with fluid resuscitation volumes in patients with severe sepsis: post hoc analyses of data from a multicentre randomised clinical trial. PLoS One 11:e0155767
6. Ait-Oufella H, Lemoinne S, Boelle PY, Galbois A, Baudel JL, Lemant J, Joffre J, Margetis D, Guidet B, Maury E, Offenstadt G (2011) Mottling score predicts survival in septic shock. Intensive Care Med 37:801–807
7. Wacharasint P, Nakada TA, Boyd JH, Russell JA, Walley KR (2012) Normal-range blood lactate concentration in septic shock is prognostic and predictive. Shock 38:4–10
8. Kellum JA, Lameire N (2013) Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care 17:204
9. Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Aneman A, Madsen KR, Moller MH, Elkjaer JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Soe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjaeldgaard AL, Fabritius ML, Mondrup F, Pott FC, Moller TP, Winkel P, Wetterslev J (2012) Hydroxyethyl starch 130/0.42 versus Ringer’s acetate in severe sepsis. N Engl J Med 367:124–134
10. ICH Steering Committee (1998) International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH Harmonised Tripartite Guideline for Statistical Principles for Clinical Trials, 3rd edn. Brookwood Medical Publications, London
11. Seymour CW, Rosengart MR (2015) Septic shock: advances in diagnosis and treatment. JAMA 314:708–717
12. Perner A, Vieillard-Baron A, Bakker J (2015) Fluid resuscitation in ICU patients: quo vadis? Intensive Care Med 41:1667–1669
13. Myburgh JA, Mythen MG (2013) Resuscitation fluids. N Engl J Med 369:1243–1251
14. Yealy DM, Kellum JA, Huang DT, Barnato AE, Weissfeld LA, Pike F, Terndrup T, Wang HE, Hou PC, LoVecchio F, Filbin MR, Shapiro NI, Angus DC (2014) A randomized trial of protocol-based care for early septic shock. N Engl J Med 370:1683–1693
15. Peake SL, Delaney A, Bailey M, Bellomo R, Cameron PA, Cooper DJ, Higgins AM, Holdgate A, Howe BD, Webb SA, Williams P (2014) Goal-directed resuscitation for patients with early septic shock. N Engl J Med 371:1496–1506
16. Mouncey PR, Osborn TM, Power GS, Harrison DA, Sadique MZ, Grieve RD, Jahan R, Harvey SE, Bell D, Bion JF, Coats TJ, Singer M, Young JD, Rowan KM (2015) Trial of early, goal-directed resuscitation for septic shock. N Engl J Med 372:1301–1311
17. Angus DC, Barnato AE, Bell D, Bellomo R, Chong CR, Coats TJ, Davies A, Delaney A, Harrison DA, Holdgate A, Howe B, Huang DT, Iwashyna T, Kellum JA, Peake SL, Pike F, Reade MC, Rowan KM, Singer M, Webb SA, Weissfeld LA, Yealy DM, Young JD (2015) A systematic review and meta-analysis of early goal-directed therapy for septic shock: the ARISE, ProCESS and ProMISe Investigators. Intensive Care Med 41:1549–1560
18. Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, Della RG, Aldecoa C, Artigas A, Jog S, Sander M, Spies C, Lefrant JY, De BD (2015) Fluid challenges in intensive care: the FENICE study: a global inception cohort study. Intensive Care Med 41:1529–1537
19. Levy MM, Rhodes A, Phillips GS, Townsend SR, Schorr CA, Beale R, Osborn T, Lemeshow S, Chiche JD, Artigas A, Dellinger RP (2014) Surviving Sepsis Campaign: association between performance metrics and outcomes in a 7.5-year study. Intensive Care Med 40:1623–1633
20. Rhodes A, Phillips G, Beale R, Cecconi M, Chiche JD, De Backer D, Divatia J, Du B, Evans L, Ferrer R, Girardis M, Koulenti D, Machado F, Simpson SQ, Tan CC, Wittebole X, Levy M (2015) The Surviving Sepsis Campaign bundles and outcome: results from the International Multicentre Prevalence Study on Sepsis (the IMPreSS study). Intensive Care Med 41:1620–1628
21. Vincent JL, Sakr Y, Sprung CL, Ranieri VM, Reinhart K, Gerlach H, Moreno R, Carlet J, Jr Le Gall, Payen D (2006) Sepsis in European intensive care units: results of the SOAP study. Crit Care Med 34:344–353
22. Vaara ST, Korhonen AM, Kaukonen KM, Nisula S, Inkinen O, Hoppu S, Laurila JJ, Mildh L, Reinikainen M, Lund V, Parviainen I, Pettila V (2012) Fluid overload is associated with an increased risk for 90-day mortality in critically ill patients with renal replacement therapy: data from the prospective FINNAKI study. Crit Care 16:R197
23. Holst LB, Haase N, Wetterslev J, Wernerman J, Guttormsen AB, Karlsson S, Johansson PI, Aneman A, Vang ML, Winding R, Nebrich L, Nibro HL, Rasmussen BS, Lauridsen JR, Nielsen JS, Oldner A, Pettila V, Cronhjort MB, Andersen LH, Pedersen UG, Reiter N, Wiis J, White JO, Russell L, Thornberg KJ, Hjortrup PB, Muller RG, Moller MH, Steensen M, Tjader I, Kilsand K, Odeberg-Wernerman S, Sjobo B, Bundgaard H, Thyo MA, Lodahl D, Maerkedahl R, Albeck C, Illum D, Kruse M, Winkel P, Perner A (2014) Lower versus higher hemoglobin threshold for transfusion in septic shock. N Engl J Med 371:1381–1391
24. Caironi P, Tognoni G, Masson S, Fumagalli R, Pesenti A, Romero M, Fanizza C, Caspani L, Faenza S, Grasselli G, Iapichino G, Antonelli M, Parrini V, Fiore G, Latini R, Gattinoni L (2014) Albumin replacement in patients with severe sepsis or septic shock. N Engl J Med 370:1412–1421
25. Asfar P, Meziani F, Hamel JF, Grelon F, Megarbane B, Anguel N, Mira JP, Dequin PF, Gergaud S, Weiss N, Legay F, Le TY, Conrad M, Robert R, Gonzalez F, Guitton C, Tamion F, Tonnelier JM, Guezennec P, Van Der Linden T, Vieillard-Baron A, Mariotte E, Pradel G, Lesieur O, Ricard JD, Herve F, du CD, Guerin C, Mercat A, Teboul JL, Radermacher P (2014) High versus low blood-pressure target in patients with septic shock. N Engl J Med 370:1583–1593