Renin Angiotensin Aldosterone System In Septic Kids

Recruiting

• Conditions: Acute Kidney Injury (Nontraumatic); Sepsis; Acute Kidney Injury Due to Sepsis

• Registration Number: NCT06295393
• Lead Sponsor: Northwell Health

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 Timeline

• Study Start: 2024-01-24
• Study First Submitted: 2024-02-08
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-05
• Last Update Submitted: 2024-03-05
• Study First Posted: 2024-03-06
• Last Update Posted: 2024-03-06
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• pediatric patients age 1 days - 18 years old with sepsis or age 1 day - 18 years and healthy.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in serum renin in sepsis	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	Comparison between healthy and septic subjects serum renin levels

Secondary Outcome Measures

Name	Time	Method
Aberrations in the renin angiotensin aldosterone system (RAAS) in sepsis associated acute kidney injury	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.	Comparison of RAAS components between sepsis with and without AKI
Aberrations in the renin angiotensin aldosterone system (RAAS) in sepsis versus healthy patients	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.	Comparison of RAAS components between sepsis and healthy
Changes in renal blood flow on Ultrasound in Sepsis	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.	Measuring renal blood flow trend over first three days of sepsis
Renal blood flow and RAAS in sepsis	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.	Comparison between blood flow by renal ultrasound and components of RAAS
Septic induced kidney injury will be associated with alterations in renal blood flow	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.	Ultrasound will measure blood flow to kidneys during sepsis and compare with serum levels of RAAS
Changes in the components of the RAAS over the first three days in sepsis	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.	Measuring components of RAAS over three days and comparing trend

Trial Locations

Locations (1)

Cohen Children's Medical Center; 🇺🇸 New Hyde Park, New York, United States