Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Nov 1;51(11):1449-1460.
doi: 10.1097/CCM.0000000000005952. Epub 2023 Jun 9.

Multiple Electrolytes Solution Versus Saline as Bolus Fluid for Resuscitation in Pediatric Septic Shock: A Multicenter Randomized Clinical Trial

Jhuma Sankar  1 , Jayashree Muralidharan  2 , A V Lalitha  3 , Ramachandran Rameshkumar  4 , Mona Pathak  5 , Rashmi Ranjan Das  6 , Vinay M Nadkarni  7 , Javed Ismail  8 , Mahadevan Subramanian  4 , Karthi Nallasamy  2 , Nishanth Dev  9 , U Vijay Kumar  1 , Kiran Kumar  1 , Taniya Sharma  1 , Kanika Jaravta  1 , Neha Thakur  2 , Praveen Aggarwal  10 , Kana Ram Jat  1 , S K Kabra  1 , Rakesh Lodha  1
Affiliations
Randomized Controlled Trial

Multiple Electrolytes Solution Versus Saline as Bolus Fluid for Resuscitation in Pediatric Septic Shock: A Multicenter Randomized Clinical Trial

Jhuma Sankar et al. Crit Care Med. .

Abstract

Objective: 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.

Design: Parallel-group, blinded multicenter trial.

Setting: PICUs of four tertiary care centers in India from 2017 to 2020.

Patients: Children up to 15 years of age with septic shock.

Methods: 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.

Interventions: MES solution ( n = 351) versus 0.9% saline ( n = 357) for bolus fluid resuscitation during the first 7 days.

Measurements and main results: 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.

Conclusions: 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.

Trial registration: ClinicalTrials.gov NCT02835157.

PubMed Disclaimer

Conflict of interest statement

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.

Comment in

References

    1. 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
    1. 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
    1. 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
    1. 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
    1. Lira A, Pinsky MR: Choices in fluid type and volume during resuscitation: Impact on patient outcomes. Ann Intensive Care. 2014; 4:38

Publication types

Associated data