Multiple Electrolytes Solution Versus Saline as Bolus Fluid for Resuscitation in Pediatric Septic Shock: A Multicenter Randomized Clinical Trial.
Journal
Critical care medicine
ISSN: 1530-0293
Titre abrégé: Crit Care Med
Pays: United States
ID NLM: 0355501
Informations de publication
Date de publication:
01 11 2023
01 11 2023
Historique:
medline:
31
10
2023
pubmed:
9
6
2023
entrez:
9
6
2023
Statut:
ppublish
Résumé
To determine if initial fluid resuscitation with balanced crystalloid (e.g., multiple electrolytes solution [MES]) or 0.9% saline adversely affects kidney function in children with septic shock. Parallel-group, blinded multicenter trial. PICUs of four tertiary care centers in India from 2017 to 2020. Children up to 15 years of age with septic shock. Children were randomized to receive fluid boluses of either MES (PlasmaLyte A) or 0.9% saline at the time of identification of shock. All children were managed as per standard protocols and monitored until discharge/death. The primary outcome was new and/or progressive acute kidney injury (AKI), at any time within the first 7 days of fluid resuscitation. Key secondary outcomes included hyperchloremia, any adverse event (AE), at 24, 48, and 72 hours, and all-cause ICU mortality. MES solution ( n = 351) versus 0.9% saline ( n = 357) for bolus fluid resuscitation during the first 7 days. The median age was 5 years (interquartile range, 1.3-9); 302 (43%) were girls. The relative risk (RR) for meeting the criteria for new and/or progressive AKI was 0.62 (95% CI, 0.49-0.80; p < 0.001), favoring the MES (21%) versus the saline (33%) group. The proportions of children with hyperchloremia were lower in the MES versus the saline group at 24, 48, and 72 hours. There was no difference in the ICU mortality (33% in the MES vs 34% in the saline group). There was no difference with regard to infusion-related AEs such as fever, thrombophlebitis, or fluid overload between the groups. Among children presenting with septic shock, fluid resuscitation with MES (balanced crystalloid) as compared with 0.9% saline resulted in a significantly lower incidence of new and/or progressive AKI during the first 7 days of hospitalization.
Identifiants
pubmed: 37294145
doi: 10.1097/CCM.0000000000005952
pii: 00003246-990000000-00167
doi:
Substances chimiques
Crystalloid Solutions
0
Saline Solution
0
Banques de données
ClinicalTrials.gov
['NCT02835157']
Types de publication
Randomized Controlled Trial
Multicenter Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1449-1460Informations de copyright
Copyright © 2023 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.
Déclaration de conflit d'intérêts
Dr. Nadkarni received funding from the Society of Critical Care Medicine as President (2023–2024). Drs. Nallasamy, U.V. Kumar, and K. Kumar’s institutions received funding from the Department of Science and Technology, Government of India. Dr. Kabra disclosed government work. The remaining authors have disclosed that they do not have any potential conflicts of interest.
Références
Rudd KE, Johnson SC, Agesa KM, et al.: Global, regional, and national sepsis incidence and mortality, 1990-2017: Analysis for the global burden of disease study. Lancet. 2020; 395:200–211
Weiss SL, Fitzgerald JC, Pappachan J, et al.; Sepsis Prevalence, Outcomes, and Therapies (SPROUT) Study Investigators and Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network: Global epidemiology of pediatric severe sepsis: The sepsis prevalence, outcomes, and therapies study. Am J Respir Crit Care Med. 2015; 191:1147–1157
Sankar J, Dhochak N, Kumar K, et al.: Comparison of international pediatric sepsis consensus conference versus sepsis-3 definitions for children presenting with septic shock to a tertiary care center in India: A retrospective study. Pediatr Crit Care Med. 2019; 20:e122–e129
Davis AL, Carcillo JA, Aneja RK, et al.: American College of Critical Care Medicine clinical practice parameters for hemodynamic support of pediatric and neonatal septic shock. Crit Care Med. 2017; 45:1061–1093
Lira A, Pinsky MR: Choices in fluid type and volume during resuscitation: Impact on patient outcomes. Ann Intensive Care. 2014; 4:38
Akech S, Maitland K; Ledermann saline groups: Choice of fluids for resuscitation in children with severe infection and shock: Systematic review. BMJ. 2010; 341:c4416
Lima MF, Neville IS, Cavalheiro S, et al.: Balanced crystalloids versus saline for perioperative intravenous fluid administration in children undergoing neurosurgery: A randomized clinical trial. J Neurosurg Anesthesiol. 2019; 31:30–35
Disma N, Mameli L, Pistorio A, et al.: A novel balanced isotonic sodium solution vs normal saline during major surgery in children up to 36 months: A multicenter RCT. Paediatr Anaesth. 2014; 24:980–986
Williams V, Jayashree M, Nallasamy K, et al.: 0.9% saline versus Plasma-Lyte as initial fluid in children with diabetic ketoacidosis (SPinK trial): A double-blind randomized controlled trial. Crit Care. 2020; 24:1
Balamuth F, Kittick M, McBride P, et al.: Pragmatic pediatric trial of balanced versus normal saline fluid in sepsis: The PRoMPT BOLUS randomized controlled trial pilot feasibility study. Acad Emerg Med. 2019; 26:1346–1356
Anantasit A, Tiacharoen D, Thasanthiah S, et al.: Abstract p-176: Balanced salt solution versus normal saline solution in pediatric septic shock: A randomized, double-blind controlled trial. Pediatr Crit Care Med. 2018; 19:102
Shaw AD, Bagshaw SM, Goldstein SL, et al.: Major complications, mortality, and resource utilization after open abdominal surgery: 0.9% saline compared to Plasma-Lyte. Ann Surg. 2012; 255:821–829
Roquilly A, Loutrel O, Cinotti R, et al.: Balanced versus chloride-rich solutions for fluid resuscitation in brain-injured patients: A randomised double-blind pilot study. Crit Care. 2013; 17:R77
Weiss SL, Peters MJ, Alhazzani W, et al.; Alhazzani saline groups: Surviving sepsis campaign international guidelines for the management of septic shock and sepsis-associated organ dysfunction in children. Pediatr Crit Care Med. 2020; 21:e52–e106
Hammond DA, Lam SW, Rech MA, et al.: Balanced crystalloids versus saline in critically ill adults: A systematic review and meta-analysis. Ann Pharmacother. 2020; 54:5–13
Liu C, Lu G, Wang D, et al.: Balanced crystalloids versus normal saline for fluid resuscitation in critically ill patients: A systematic review and meta-analysis with trial sequential analysis. Am J Emerg Med. 2019; 37:2072–2078
Carcillo JA, Fields A: Clinical practice parameters for hemodynamic support of pediatric and neonatal patients in septic shock. J Pediatr (Rio J). 2002; 78:449–466
Goldstein B, Giroir B, Randolph A; International Consensus Conference on Pediatric Sepsis: International pediatric sepsis consensus conference: Definitions for sepsis and organ dysfunction in pediatrics. Pediatr Crit Care Med. 2005; 6:2–8
Palevsky PM, Liu KD, Brophy PD, et al.: KDOQI US commentary on the 2012 KDIGO clinical practice guideline for acute kidney injury. Am J Kidney Dis. 2013; 61:649–672
Sanchez-Pinto LN MD1, Goldstein SL MD2, Schneider JB MD3, et al.: Association between progression and improvement of acute kidney injury and mortality in critically ill children*. Pediatr Crit Care Med. 2015; 16:703–710
Mehta P, Sinha A, Sami A, et al.: Incidence of acute kidney injury in hospitalized children. Indian Pediatr. 2012; 49:537–542
Ozkaya PY, Taner S, Ersayoğlu I, et al.: Sepsis associated acute kidney injury in pediatric intensive care unit. Ther Apher Dial. 2023; 27:73–82
Fitzgerald JC, Basu RK, Akcan-Arikan A, et al.; Sepsis PRevalence, OUtcomes, and Therapies Study Investigators and Pediatric Acute Lung Injury and Sepsis Investigators Network: Acute kidney injury in pediatric severe sepsis: An independent risk factor for death and new disability. Crit Care Med. 2016; 44:2241–2250
Fine JP, Gray RJ: A proportional hazards model for the sub-distribution of a competing risk. J Am Stat Assoc. 1999; 94:496–509.
Hermon MM, Etmayr T, Brandt JB, et al.: Pediatric infection and sepsis in five age subgroups: Single-center registry. Wien Med Wochenschr. 2021; 171:29–35
Rao BN, Rathia SK, Phuljhele S, et al.: Incidence, risk factors, clinical profile, and determinants (affecting outcome) of new onset acute kidney injury developing in critically ill patients in pediatric intensive care unit of a tertiary hospital in India. Pediatr Rev. 2019; 6:252–261
Louzada CF, Ferreira AR: Evaluation of the prevalence and factors associated with acute kidney injury in a pediatric intensive care unit. J Pediatr (Rio J). 2021; 97:426–432
Zampieri FG, Machado FR, Biondi RS, et al.: Effect of intravenous fluid treatment with a balanced solution vs 0.9% saline solution on mortality in critically ill patients: The BaSICS Randomized Clinical Trial. JAMA. 2021; 326:818–829
Semler MW, Self WH, Wanderer JP, et al.; SMART Investigators and the Pragmatic Critical Care Research Group: Balanced crystalloids versus saline in critically ill adults. N Engl J Med. 2018; 378:829–839
Self WH, Semler MW, Wanderer JP, et al.; SALT-ED Investigators: Balanced crystalloids versus saline in noncritically ill adults. N Engl J Med. 2018; 378:819–828
Brown RM, Wang L, Coston TD, et al.: Balanced crystalloids versus saline in sepsis. A secondary analysis of the SMART clinical trial. Am J Respir Crit Care Med. 2019; 200:1487–1495
Zwager CL, Tuinman PR, de Grooth H-J, et al.: Why physiology will continue to guide the choice between balanced crystalloids and normal saline: A systematic review and meta-analysis. Crit Care. 2019; 23:366
Suetrong B, Pisitsak C, Boyd JH, et al.: Hyperchloremia and moderate increase in serum chloride are associated with acute kidney injury in severe sepsis and septic shock patients. Crit Care. 2016; 20:315
Oh TK, Song IA, Jeon YT, et al.: Fluctuations in serum chloride and acute kidney injury among critically ill patients: A retrospective association study. J Clin Med. 2019; 8:447
Kimura S, de la Hoz MAA, Raines NH, et al.: Association of chloride ion and sodium-chloride difference with acute kidney injury and mortality in critically ill patients. Crit Care Explor. 2020; 2:e0247
Wilcox CS, Peart WS: Release of renin and angiotensin II into plasma and lymph during hyperchloremia. Am J Physiol. 1987; 253:F734–F741
Quilley CP, Lin YS, McGiff JC: Chloride anion concentration as a determinant of renal vascular responsiveness to vasoconstrictor agents. Br J Pharmacol. 1993; 108:106–110
Chowdhury AH, Cox EF, Francis ST, et al.: A randomized, controlled, double-blind crossover study on the effects of 2-L infusions of 0.9% saline and Plasma-LyteI 148 on renal blood flow velocity and renal cortical tissue perfusion in healthy volunteers. Ann Surg. 2012; 256:18–24
Kellum JA, Song M, Almasri E: Hyperchloremic acidosis increases circulating inflammatory molecules in experimental sepsis. Chest. 2006; 130:962–967
Tucker VL: Plasma ANP levels and protein extravasation during graded expansion with equilibrated whole blood. Am J Physiol. 1996; 271:R601–R609
Torres LN, Chung KK, Salgado CL, et al.: Low-volume resuscitation with normal saline is associated with microvascular endothelial dysfunction after hemorrhage in rats, compared to colloids and balanced crystalloids. Crit Care. 2017; 21:160
Antequera Martín AM, Barea Mendoza JA, Muriel A, et al.: Buffered solutions versus 0.9% saline for resuscitation in critically ill adults and children. Cochrane Database Syst Rev. 2019; 7:CD012247