NCT06295393

Renin Angiotensin Aldosterone System In Septic Kids

Early Identification of Sepsis-associated Acute Kidney Injury Using Ultrasonography Measurements and Renin and Angiotensin Levels in Children and Adults.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 74 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 1 Day – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sepsis
• Acute Kidney Injury Due to Sepsis
• Acute Kidney Injury (Nontraumatic)

Timeline

• Start date: 2024-01-24
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2024-03-06
• Last updated: 2024-03-06

Locations

1 site across 1 country: United States