Renin Angiotensin Aldosterone System In Septic Kids (RISK)
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About
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.
Full 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.
Enrollment
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Volunteers
Inclusion criteria
- pediatric patients age 1 days - 18 years old with sepsis or age 1 day - 18 years and healthy.
Exclusion criteria
- -pre-existing end stage renal disease (ESRD), chronic renal failure (CRF), home use of angiotensin converting enzyme inhibitor(ACE) or angiotensin receptor blocker(ARB) medications, pre-existing congestive heart failure (CHF), and unrepaired congenital heart disease
Trial design
74 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Grace Fisler, MD
Data sourced from clinicaltrials.gov
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