Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
PRoMPT BOLUS: Balanced vs Normal Saline in Pediatric Septic Shock
NCT04102371Phase 3
Key facts
- Status
- Completed
- Start
- Aug 2020
- Primary completion
- Dec 2025
- Countries
- 1
- Sponsor
- Children's Hospital of Philadelphia
- Modality
- Small Molecules
- Conditions
- septic shock
01
Overview
Phase 3, randomised, open-label trial of lactated ringer's solution and plasma-lyte in septic shock (2 arms), sponsored by Children's Hospital of Philadelphia. Primary endpoint: Major Adverse Kidney Events within 30 days. Started Aug 2020; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Balanced fluids (BF)
Lactated Ringer's or Plasma-Lyte used for all fluid boluses and maintenance fluids
0.9% "Normal" Saline Fluid (NS)
0.9% normal saline used for all fluid boluses and maintenance fluids
03
Who it enrols
Children >2 months to <18 years with suspected septic shock requiring fluid resuscitation, who have received <=40 mL/kg of fluid prior to randomization. Excludes patients with known hyperkalemia, hypercalcemia, severe hepatic or renal impairment, or impending brain herniation.
04
Endpoints
Primary
Major Adverse Kidney Events within 30 days
Secondary
Proportion of participants with persistent kidney dysfunction
Proportion of participants with new inpatient renal replacement therapy
Hospital-free days alive between randomization and day 27
Proportion of participants with all-cause hospital mortality
Proportion of participants with all-cause mortality at 90 days
Proportion of participants with hyperlactatemia
Proportion of participants with hyperkalemia
Proportion of participants with hypercalcemia
Beyond the preview
Go deeper on NCT04102371.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT04102371.