Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis

Children's Hospital of Philadelphia

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Brief summary

The objectives of this multicenter pragmatic clinical trial are to compare the effectiveness and relative safety of balanced fluid resuscitation versus 0.9% "normal" saline in children with septic shock, including whether balanced fluid resuscitation can reduce progression of kidney injury.

Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.

Trial details

acronym
PRoMPT BOLUS
status
COMPLETED
phase
PHASE3
study type
INTERVENTIONAL
enrollment
9041
sponsor
Children's Hospital of Philadelphia
conditions
Shock; Septic
interventions
DRUG: Lactated Ringer; DRUG: Normal Saline; DRUG: Plasma-lyte
start date
2020-08-25
start date type
ACTUAL
primary completion date
2025-12-01
has results
false
data source
ClinicalTrials.gov
data processed
2026-10-29T09:00:05
modifications
selected fields only; whitespace normalized; brief summary truncated to 2,000 characters

Record

Archive ID
nct:NCT04102371
Published
Sep 25, 2019
Updated
Mar 5, 2026
Venue
ClinicalTrials.gov
ClinicalTrials.gov
NCT04102371
Categories
Shock, Septic
License
ClinicalTrials.gov terms (attribution, processing date, modifications noted)
Provenance
clinicaltrials

Topics