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.
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 Type
OBSERVATIONAL
Enrollment
74
Cohen Children's Medical Center
New Hyde Park, New York, United States
RECRUITINGDifference in serum renin in sepsis
Comparison between healthy and septic subjects serum renin levels
Time frame: For sepsis cohort point 1 collection within the first 48 hours from of meeting sepsis criteria, point 2: 48-72 hours and point 3: 72-94 hours. For the healthy cohort blood drawn at a single time point up to 24 hours
Aberrations in the renin angiotensin aldosterone system (RAAS) in sepsis associated acute kidney injury
Comparison of RAAS components between sepsis with and without AKI
Time frame: For sepsis cohort point 1 collection within the first 48 hours from of meeting sepsis criteria, point 2: 48-72 hours and point 3: 72-94 hours.
Septic induced kidney injury will be associated with alterations in renal blood flow
Ultrasound will measure blood flow to kidneys during sepsis and compare with serum levels of RAAS
Time frame: For sepsis cohort point 1 collection within the first 48 hours from of meeting sepsis criteria, point 2: 48-72 hours and point 3: 72-94 hours.
Aberrations in the renin angiotensin aldosterone system (RAAS) in sepsis versus healthy patients
Comparison of RAAS components between sepsis and healthy
Time frame: For sepsis cohort point 1 collection within the first 48hours from of meeting sepsis criteria, point 2: 48-72 hours and point 3: 72-94hours. For the healthy cohort blood drawn at a single time point.
Changes in the components of the RAAS over the first three days in sepsis
Measuring components of RAAS over three days and comparing trend
Time frame: For sepsis cohort point 1 collection within the first 48hours from of meeting sepsis criteria, point 2: 48-72 hours and point 3: 72-94hours.
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Changes in renal blood flow on Ultrasound in Sepsis
Measuring renal blood flow trend over first three days of sepsis
Time frame: For sepsis cohort point 1 collection within the first 48 hours from of meeting sepsis criteria, point 2: 48-72 hours and point 3: 72-94 hours.
Renal blood flow and RAAS in sepsis
Comparison between blood flow by renal ultrasound and components of RAAS
Time frame: For sepsis cohort point 1 collection within the first 48 hours from of meeting sepsis criteria, point 2: 48-72 hours and point 3: 72-94hours.