Effects of restrictive fluid therapy on the time to resolution of hyperlactatemia in ICU patients with septic shock. A secondary post hoc analysis of the CLASSIC randomized trial.
Fluid therapy
Hyperlactatemia
Lactate
Sepsis
Septic shock
Journal
Intensive care medicine
ISSN: 1432-1238
Titre abrégé: Intensive Care Med
Pays: United States
ID NLM: 7704851
Informations de publication
Date de publication:
10 Apr 2024
10 Apr 2024
Historique:
received:
25
12
2023
accepted:
29
02
2024
medline:
10
4
2024
pubmed:
10
4
2024
entrez:
10
4
2024
Statut:
aheadofprint
Résumé
The aim of this study was to examine the effects of intravenous (IV) fluid restriction on time to resolution of hyperlactatemia in septic shock. Hyperlactatemia in sepsis is associated with worse outcome. Sepsis guidelines suggest targeting lactate clearance to guide fluid therapy despite the complexity of hyperlactatemia and the potential harm of fluid overload. We conducted a post hoc analysis of serial plasma lactate concentrations in a sub-cohort of 777 patients from the international multicenter clinical CLASSIC trial (restriction of intravenous fluids in intensive care unit (ICU) patients with septic shock). Adult ICU patients with septic shock had been randomized to restrictive (n = 385) or standard (n = 392) intravenous fluid therapy. The primary outcome, time to resolution of hyperlactatemia, was analyzed with a competing-risks regression model. Death and discharge were competing outcomes, and administrative censoring was imposed 72 h after randomization if hyperlactatemia persisted. The regression analysis was adjusted for the same stratification variables and covariates as in the original CLASSIC trial analysis. The hazard ratios (HRs) for the cumulative probability of resolution of hyperlactatemia, in the restrictive vs the standard group, in the unadjusted analysis, with time split, were 0.94 (confidence interval (CI) 0.78-1.14) at day 1 and 1.21 (0.89-1.65) at day 2-3. The adjusted analyses were consistent with the unadjusted results. In this post hoc retrospective analysis of a multicenter randomized controlled trial (RCT), a restrictive intravenous fluid strategy did not seem to affect the time to resolution of hyperlactatemia in adult ICU patients with septic shock.
Identifiants
pubmed: 38598125
doi: 10.1007/s00134-024-07385-9
pii: 10.1007/s00134-024-07385-9
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. The Author(s).
Références
Shankar-Hari M, Phillips GS, Levy ML, Seymour CW, Liu VX, Deutschman CS 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(8):775–787
doi: 10.1001/jama.2016.0289
pubmed: 26903336
pmcid: 4910392
Hernandez G, Bellomo R, Bakker J (2019) The ten pitfalls of lactate clearance in sepsis. Intensive Care Med 45(1):82–85
doi: 10.1007/s00134-018-5213-x
pubmed: 29754310
Bakker J, de Backer D, Hernandez G (2016) Lactate-guided resuscitation saves lives: we are not sure. Intensive Care Med 42(3):472–474
doi: 10.1007/s00134-016-4220-z
pubmed: 26831675
Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C et al (2021) Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Crit Care Med 49(11):e1063–e1143
doi: 10.1097/CCM.0000000000005337
pubmed: 34605781
Kushimoto S, Akaishi S, Sato T, Nomura R, Fujita M, Kudo D et al (2016) Lactate, a useful marker for disease mortality and severity but an unreliable marker of tissue hypoxia/hypoperfusion in critically ill patients. Acute Med Surg 3(4):293–297
doi: 10.1002/ams2.207
pubmed: 29123802
pmcid: 5667335
Bloos F, Zhang Z, Boulain T (2016) Lactate-guided resuscitation saves lives: yes. Intensive Care Med 42(3):466–469
doi: 10.1007/s00134-015-4196-0
pubmed: 26831674
Monnet X, Delaney A, Barnato A (2016) Lactate-guided resuscitation saves lives: no. Intensive Care Med 42(3):470–471
doi: 10.1007/s00134-016-4235-5
pubmed: 26831673
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(2):259–265
doi: 10.1097/CCM.0b013e3181feeb15
pubmed: 20975548
Liu G, Haijin L, An Y, Wei X, Yi X, Yi H (2017) Early lactate levels for prediction of mortality in patients with sepsis or septic shock: a meta-analysis. Int J Clin Exp Med 10:37–47
Meyhoff TS, Hjortrup PB, Møller MH, Wetterslev J, Lange T, Kjaer MN et al (2019) Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial-Protocol and statistical analysis plan. Acta Anaesthesiol Scand 63(9):1262–1271
doi: 10.1111/aas.13434
pubmed: 31276193
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M et al (2016) The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA 315(8):801–810
doi: 10.1001/jama.2016.0287
pubmed: 26903338
pmcid: 4968574
Meyhoff TS, Hjortrup PB, Wetterslev J, Sivapalan P, Laake JH, Cronhjort M et al (2022) Restriction of intravenous fluid in ICU patients with septic shock. N Engl J Med 386(26):2459–2470
doi: 10.1056/NEJMoa2202707
pubmed: 35709019
Kjær MN, Meyhoff TS, Sivapalan P, Granholm A, Hjortrup PB, Madsen MB et al (2023) Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock. Intensive Care Med 49(7):820–830
doi: 10.1007/s00134-023-07114-8
pubmed: 37330928
pmcid: 10354110
Granholm A, Perner A, Krag M, Hjortrup PB, Haase N, Holst LB et al (2017) Simplified Mortality Score for the Intensive Care Unit (SMS-ICU): protocol for the development and validation of a bedside clinical prediction rule. BMJ Open 7(3):e015339
doi: 10.1136/bmjopen-2016-015339
pubmed: 28279999
pmcid: 5353313
Haller B, Schmidt G, Ulm K (2013) Applying competing risks regression models: an overview. Lifetime Data Anal 19(1):33–58
doi: 10.1007/s10985-012-9230-8
pubmed: 23010807
Bradburn MJ, Clark TG, Love SB, Altman DG (2003) Survival analysis Part III: multivariate data analysis—choosing a model and assessing its adequacy and fit. Br J Cancer 89(4):605–611
doi: 10.1038/sj.bjc.6601120
pubmed: 12915864
pmcid: 2376927
Hjortrup PB, Haase N, Wetterslev J, Lange T, Bundgaard H, Rasmussen BS et al (2017) Effects of fluid restriction on measures of circulatory efficacy in adults with septic shock. Acta Anaesthesiol Scand 61(4):390–398
doi: 10.1111/aas.12862
pubmed: 28150304
Hjortrup PB, Haase N, Bundgaard H, Thomsen SL, Winding R, Pettilä V et al (2016) Restricting volumes of resuscitation fluid in adults with septic shock after initial management: the CLASSIC randomised, parallel-group, multicentre feasibility trial. Intensive Care Med 42(11):1695–1705
doi: 10.1007/s00134-016-4500-7
pubmed: 27686349
Nguyen HB, Rivers EP, Knoblich BP, Jacobsen G, Muzzin A, Ressler JA et al (2004) Early lactate clearance is associated with improved outcome in severe sepsis and septic shock. Crit Care Med 32(8):1637–1642
doi: 10.1097/01.CCM.0000132904.35713.A7
pubmed: 15286537
Arnold RC, Shapiro NI, Jones AE, Schorr C, Pope J, Casner E et al (2009) Multicenter study of early lactate clearance as a determinant of survival in patients with presumed sepsis. Shock 32(1):35–39
doi: 10.1097/SHK.0b013e3181971d47
pubmed: 19533847
Chertoff J, Chisum M, Garcia B, Lascano J (2015) Lactate kinetics in sepsis and septic shock: a review of the literature and rationale for further research. J Intensive Care 3:39
doi: 10.1186/s40560-015-0105-4
pubmed: 26445673
pmcid: 4594907
Kattan E, Hernández G, Ospina-Tascón G, Valenzuela ED, Bakker J, Castro R (2020) A lactate-targeted resuscitation strategy may be associated with higher mortality in patients with septic shock and normal capillary refill time: a post hoc analysis of the ANDROMEDA-SHOCK study. Ann Intensive Care 10(1):114
doi: 10.1186/s13613-020-00732-1
pubmed: 32845407
pmcid: 7450018
Hernández G, Ospina-Tascón GA, Damiani LP, Estenssoro E, Dubin A, Hurtado J et al (2019) Effect of a resuscitation strategy targeting peripheral perfusion status vs serum lactate levels on 28-day mortality among patients with septic shock: the ANDROMEDA-SHOCK randomized clinical trial. JAMA 321(7):654–664
doi: 10.1001/jama.2019.0071
pubmed: 30772908
pmcid: 6439620
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(8):739–746
doi: 10.1001/jama.2010.158
pubmed: 20179283
pmcid: 2918907
Jansen TC, van Bommel J, Schoonderbeek FJ, Sleeswijk Visser SJ, van der Klooster JM, Lima AP et al (2010) Early lactate-guided therapy in intensive care unit patients: a multicenter, open-label, randomized controlled trial. Am J Respir Crit Care Med 182(6):752–761
doi: 10.1164/rccm.200912-1918OC
pubmed: 20463176
Kattan E, Bakker J, Estenssoro E, Ospina-Tascón GA, Cavalcanti AB, Backer D et al (2022) Hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial study protocol. Rev Bras Ter Intensiva 34(1):96–106
doi: 10.5935/0103-507X.20220004-en
pubmed: 35766659
pmcid: 9345585