Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295393
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-08
Brief Title:
Renin Angiotensin Aldosterone System In Septic Kids
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Early Identification of Sepsis-associated Acute Kidney Injury Using Ultrasonography Measurements and Renin and Angiotensin Levels in Children and Adults
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RISK
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
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 sepsis37 healthy with enrollment ratio 11 and expected different of 50 in renin levels this provides 80 power at an alpha of 005
Sepsis identified as pediatric Sequential Organ Failure Assessment pSOFA 2 infection andor 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
Powered to collect 74 patients total 37 sepsis37 healthy with enrollment ratio 11 and expected different of 50 in renin levels this provides 80 power at an alpha of 005
Sepsis identified as pediatric Sequential Organ Failure Assessment pSOFA 2 infection andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None