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
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu časopisecké články, randomizované kontrolované studie, multicentrická studie
PubMed
38598125
PubMed Central
PMC11078841
DOI
10.1007/s00134-024-07385-9
PII: 10.1007/s00134-024-07385-9
Knihovny.cz E-zdroje
- Klíčová slova
- Fluid therapy, Hyperlactatemia, Lactate, Sepsis, Septic shock,
- MeSH
- časové faktory MeSH
- hyperlaktatemie * etiologie MeSH
- jednotky intenzivní péče * statistika a číselné údaje MeSH
- kyselina mléčná krev MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- septický šok * terapie komplikace krev mortalita MeSH
- tekutinová terapie * metody normy MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- kyselina mléčná MeSH
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
Collaboration for Research in Intensive Care Copenhagen Denmark
Department of Clinical Medicine University of Copenhagen Copenhagen Denmark
Department of Clinical Science and Education Karolinska Institutet Södersjukhuset Stockholm Sweden
Department of Clinical Sciences Danderyd Hospital Stockholm Sweden
Department of Intensive Care Copenhagen University Hospital Rigshospitalet Copenhagen Denmark
Zobrazit více v PubMed
Shankar-Hari M, Phillips GS, Levy ML, Seymour CW, Liu VX, Deutschman CS, et al. 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. 2016;315(8):775–787. doi: 10.1001/jama.2016.0289. PubMed DOI PMC
Hernandez G, Bellomo R, Bakker J. The ten pitfalls of lactate clearance in sepsis. Intensive Care Med. 2019;45(1):82–85. doi: 10.1007/s00134-018-5213-x. PubMed DOI PMC
Bakker J, de Backer D, Hernandez G. Lactate-guided resuscitation saves lives: we are not sure. Intensive Care Med. 2016;42(3):472–474. doi: 10.1007/s00134-016-4220-z. PubMed DOI
Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, et al. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Crit Care Med. 2021;49(11):e1063–e1143. doi: 10.1097/CCM.0000000000005337. PubMed DOI
Kushimoto S, Akaishi S, Sato T, Nomura R, Fujita M, Kudo D, et al. Lactate, a useful marker for disease mortality and severity but an unreliable marker of tissue hypoxia/hypoperfusion in critically ill patients. Acute Med Surg. 2016;3(4):293–297. doi: 10.1002/ams2.207. PubMed DOI PMC
Bloos F, Zhang Z, Boulain T. Lactate-guided resuscitation saves lives: yes. Intensive Care Med. 2016;42(3):466–469. doi: 10.1007/s00134-015-4196-0. PubMed DOI
Monnet X, Delaney A, Barnato A. Lactate-guided resuscitation saves lives: no. Intensive Care Med. 2016;42(3):470–471. doi: 10.1007/s00134-016-4235-5. PubMed DOI
Boyd JH, Forbes J, Nakada TA, Walley KR, Russell JA. Fluid resuscitation in septic shock: a positive fluid balance and elevated central venous pressure are associated with increased mortality. Crit Care Med. 2011;39(2):259–265. doi: 10.1097/CCM.0b013e3181feeb15. PubMed DOI
Liu G, Haijin L, An Y, Wei X, Yi X, Yi H. Early lactate levels for prediction of mortality in patients with sepsis or septic shock: a meta-analysis. Int J Clin Exp Med. 2017;10:37–47.
Meyhoff TS, Hjortrup PB, Møller MH, Wetterslev J, Lange T, Kjaer MN, et al. Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial-Protocol and statistical analysis plan. Acta Anaesthesiol Scand. 2019;63(9):1262–1271. doi: 10.1111/aas.13434. PubMed DOI
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, et al. The third international consensus definitions for sepsis and septic shock (Sepsis-3) JAMA. 2016;315(8):801–810. doi: 10.1001/jama.2016.0287. PubMed DOI PMC
Meyhoff TS, Hjortrup PB, Wetterslev J, Sivapalan P, Laake JH, Cronhjort M, et al. Restriction of intravenous fluid in ICU patients with septic shock. N Engl J Med. 2022;386(26):2459–2470. doi: 10.1056/NEJMoa2202707. PubMed DOI
Kjær MN, Meyhoff TS, Sivapalan P, Granholm A, Hjortrup PB, Madsen MB, et al. Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock. Intensive Care Med. 2023;49(7):820–830. doi: 10.1007/s00134-023-07114-8. PubMed DOI PMC
Granholm A, Perner A, Krag M, Hjortrup PB, Haase N, Holst LB, et al. Simplified Mortality Score for the Intensive Care Unit (SMS-ICU): protocol for the development and validation of a bedside clinical prediction rule. BMJ Open. 2017;7(3):e015339. doi: 10.1136/bmjopen-2016-015339. PubMed DOI PMC
Haller B, Schmidt G, Ulm K. Applying competing risks regression models: an overview. Lifetime Data Anal. 2013;19(1):33–58. doi: 10.1007/s10985-012-9230-8. PubMed DOI
Bradburn MJ, Clark TG, Love SB, Altman DG. Survival analysis Part III: multivariate data analysis—choosing a model and assessing its adequacy and fit. Br J Cancer. 2003;89(4):605–611. doi: 10.1038/sj.bjc.6601120. PubMed DOI PMC
Hjortrup PB, Haase N, Wetterslev J, Lange T, Bundgaard H, Rasmussen BS, et al. Effects of fluid restriction on measures of circulatory efficacy in adults with septic shock. Acta Anaesthesiol Scand. 2017;61(4):390–398. doi: 10.1111/aas.12862. PubMed DOI
Hjortrup PB, Haase N, Bundgaard H, Thomsen SL, Winding R, Pettilä V, et al. Restricting volumes of resuscitation fluid in adults with septic shock after initial management: the CLASSIC randomised, parallel-group, multicentre feasibility trial. Intensive Care Med. 2016;42(11):1695–1705. doi: 10.1007/s00134-016-4500-7. PubMed DOI
Nguyen HB, Rivers EP, Knoblich BP, Jacobsen G, Muzzin A, Ressler JA, et al. Early lactate clearance is associated with improved outcome in severe sepsis and septic shock. Crit Care Med. 2004;32(8):1637–1642. doi: 10.1097/01.CCM.0000132904.35713.A7. PubMed DOI
Arnold RC, Shapiro NI, Jones AE, Schorr C, Pope J, Casner E, et al. Multicenter study of early lactate clearance as a determinant of survival in patients with presumed sepsis. Shock. 2009;32(1):35–39. doi: 10.1097/SHK.0b013e3181971d47. PubMed DOI
Chertoff J, Chisum M, Garcia B, Lascano J. Lactate kinetics in sepsis and septic shock: a review of the literature and rationale for further research. J Intensive Care. 2015;3:39. doi: 10.1186/s40560-015-0105-4. PubMed DOI PMC
Kattan E, Hernández G, Ospina-Tascón G, Valenzuela ED, Bakker J, Castro R. 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. 2020;10(1):114. doi: 10.1186/s13613-020-00732-1. PubMed DOI PMC
Hernández G, Ospina-Tascón GA, Damiani LP, Estenssoro E, Dubin A, Hurtado J, et al. 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. 2019;321(7):654–664. doi: 10.1001/jama.2019.0071. PubMed DOI PMC
Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010;303(8):739–746. doi: 10.1001/jama.2010.158. PubMed DOI PMC
Jansen TC, van Bommel J, Schoonderbeek FJ, Sleeswijk Visser SJ, van der Klooster JM, Lima AP, et al. Early lactate-guided therapy in intensive care unit patients: a multicenter, open-label, randomized controlled trial. Am J Respir Crit Care Med. 2010;182(6):752–761. doi: 10.1164/rccm.200912-1918OC. PubMed DOI
Kattan E, Bakker J, Estenssoro E, Ospina-Tascón GA, Cavalcanti AB, Backer D, et al. 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. 2022;34(1):96–106. doi: 10.5935/0103-507X.20220004-en. PubMed DOI PMC