# Comparative effectiveness of balanced fluids versus normal saline to reduce acute and chronic kidney disease in children with sepsis

> **NIH NIH P50** · CHILDREN'S HOSP OF PHILADELPHIA · 2024 · $113,332

## Abstract

PROJECT SUMMARY
Acute kidney injury (AKI) is a risk factor for adverse outcomes in critically ill children, including prolonged 
hospitalization, disability, and death. AKI is particularly significant for children with sepsis, a medical emergency 
due to life-threatening organ dysfunction from infection that affects over 72,000 children in the US and four million 
children worldwide each year. Children with sepsis-induced AKI and acute kidney disease (AKD, persistent 
kidney dysfunction of <90 days duration) may also be at risk for chronic kidney disease (CKD). Specific risk 
factors for AKI and CKD among children with sepsis remain poorly defined and, importantly, gaps remain in 
identifying the best therapies to prevent sepsis-induced AKI, AKD, and CKD. Crystalloid fluid, the cornerstone of 
resuscitation for septic shock, has key biological effects on kidney function. Emerging data in adults suggest that 
resuscitation with 0.9% “normal” saline (NS) is more likely to induceAKI and AKD compared to resuscitation with 
balanced fluids (BF). Few data on the impact of fluid resuscitation on kidney function in children exist. In this 
study, we will perform an ancillary study to the PRagMatic Pediatric Trial of Balanced vs. nOrmaL saline flUid in 
Sepsis (PRoMPT BOLUS) randomized clinical trial. That trial is randomizing children in emergency departments
with suspected septic shock to fluid resuscitation with either NS or BF. The trial will determine the comparative 
effectiveness of different crystalloids on 30-day kidney function and death in children with suspected septic 
shock. However, data on outcomes such as AKI or CKD will not be collected in direct follow-up of trial 
participants. A remaining knowledge gap after trial completion will therefore be whether BF resuscitation in 
pediatric sepsis protects against AKI and translates to a decrease in CKD. To assess these important kidney 
outcomes, we will use the Pediatric Center of Excellence in Nephrology (PCEN) Learning Health System Core
to link clinical trial data to electronic health record data available in PEDSnet (pedsnet.org) to augment trial 
outcome analyses. The primary objectives of this study are to: 1) assess whether resuscitation with BF instead 
of NS will decrease AKI and translate to a decrease in CKD in trial participants, and 2) measure the real-world 
impact of crystalloid fluid choice on sepsis-induced AKI and CKD in the larger PEDSnet source population. To 
achieve these objectives, we will utilize electronic health record data in PEDSnet to measure AKI and CKD in 
2,450 children enrolled in the PRoMPT BOLUS study at 7 trial sites. To demonstrate generalizability of trial 
results using a real-world comparison, we will determine the impact of crystalloid fluid exposure on AKI and CKD 
in a broader cohort of over 16,600 children in PEDSnet presenting to an ED for treatment of septic shock using 
a quasi-experimental observational study design. We will also determine othe...

## Key facts

- **NIH application ID:** 10913365
- **Project number:** 5P50DK114786-08
- **Recipient organization:** CHILDREN'S HOSP OF PHILADELPHIA
- **Principal Investigator:** SUSAN L. FURTH
- **Activity code:** P50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $113,332
- **Award type:** 5
- **Project period:** 2017-09-18 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10913365

## Citation

> US National Institutes of Health, RePORTER application 10913365, Comparative effectiveness of balanced fluids versus normal saline to reduce acute and chronic kidney disease in children with sepsis (5P50DK114786-08). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10913365. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*
