Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT06295393
Brief Summary:
Prospective observational cohort study; pediatric sepsis vs. healthy pediatric subjects and pediatric sepsis with acute kidney injury (AKI) vs without AKI.
Blood samples and renal ultrasound will be collected on sequential days for septic subject and one time for the healthy patients.
Enzyme-linked immunosorbent assays (ELISA) with be run on serum plasma to compare the renin-angiotensin-aldosterone system (RAAS) between groups.
Detailed Description:
Prospective observational cohort study; pediatric sepsis vs. healthy pediatric subjects and pediatric sepsis with AKI vs without AKI.
Powered to collect 74 patients total (37 sepsis,37 healthy) with enrollment ratio 1:1 and expected different of 50% in renin levels, this provides 80% power at an alpha of 0.05.
Sepsis identified as pediatric Sequential Organ Failure Assessment (pSOFA) \>/= 2 + infection and/or Phoenix sepsis criteria.
Collecting blood samples on subsequent days of hospitalization. For healthy patients, a one-time blood draw will be obtained .
Renal ultrasound will be performed on day 1, 2 and 3 of hospitalization.
Blood will be collected and plasma stored at -80 degrees Celsius.
Plasma thawed in batches and ELISAs for RAAS components.
Demographic data will be collected.
Study:
NCT06295393
Study Brief:
Protocol Section:
NCT06295393