UnknownNot Applicable

Renin Angiotensin Aldosterone System In Septic Kids

United States74 participantsStarted 2024-01-24

Plain-language 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.

Who can participate

Age range

1 Day – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study is focused on measuring renin levels in children with sepsis — is this an observational study where my child would just have blood drawn and monitored, or would it involve any experimental treatments?
2Since the recruitment status is listed as unknown, can you find out whether this trial is actually still enrolling patients, and if so, whether our hospital or a nearby center is participating?
3The study looks at the renin-angiotensin-aldosterone system in sepsis-related kidney injury — how might understanding my child's renin levels change or guide their treatment compared to what's already being done for them?
4Given that this trial involves children who already have sepsis and acute kidney injury, would participating require any additional procedures beyond what my child would normally undergo as part of their care?
5Are there standard-of-care approaches for managing sepsis-related kidney injury that you'd recommend we prioritize first, and would participating in this study interfere with or complement those treatments?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference in serum renin in sepsis

Timeframe: 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

Trial details

NCT IDNCT06295393

SponsorNorthwell Health

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-01

Contact for this trial

Grace Fisler, MD

203-671-0654 gfisler@northwell.edu

View on ClinicalTrials.gov More Sepsis trials