Renin Angiotensin Aldosterone System In Septic Kids (RISK)
March 5, 2024 updated by: Northwell Health
Early Identification of Sepsis-associated Acute Kidney Injury Using Ultrasonography Measurements and Renin and Angiotensin Levels in Children and Adults.
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.
Study Overview
Status
Recruiting
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 Type
Observational
Enrollment (Estimated)
74
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Grace Fisler, MD
- Phone Number: 203-671-0654
- Email: gfisler@northwell.edu
Study Locations
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New York
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New Hyde Park, New York, United States, 11004
- Recruiting
- Cohen Children's Medical Center
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Contact:
- Grace Fisler, MD
- Email: gfisler@northwell.edu
-
Contact:
- Shannon A Moriarty
- Phone Number: 631-834-0984
- Email: smoriarty2@northwell.edu
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Pediatric subjects, age 1 day to 18 years.
Septic cohort will meet criteria for sepsis (pSOFA >/= 2 or Phoenix criteria) and healthy cohort.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Pediatric Septic
1 day -18 year olds admitted to the ICU meeting criteria for sepsis define as pSOFA >/= 2 and/or Phoenix score.
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Healthy
1 day - 18 year old; healthy outpatient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in serum renin in 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. For the healthy cohort blood drawn at a single time point up to 24 hours
|
Comparison between healthy and septic subjects serum renin levels
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Aberrations in the renin angiotensin aldosterone system (RAAS) in sepsis associated acute kidney injury
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.
|
Comparison of RAAS components between sepsis with and without AKI
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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
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.
|
Ultrasound will measure blood flow to kidneys during sepsis and compare with serum levels of RAAS
|
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
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.
|
Comparison of RAAS components between sepsis and healthy
|
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
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.
|
Measuring components of RAAS over three days and comparing trend
|
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
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.
|
Measuring renal blood flow trend over first three days of 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.
|
|
Renal blood flow and RAAS in 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: 72-94hours.
|
Comparison between blood flow by renal ultrasound and components of RAAS
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl (2011). 2017 Jul;7(1):1-59. doi: 10.1016/j.kisu.2017.04.001. Epub 2017 Jun 21. No abstract available. Erratum In: Kidney Int Suppl (2011). 2017 Dec;7(3):e1.
- Matics TJ, Sanchez-Pinto LN. Adaptation and Validation of a Pediatric Sequential Organ Failure Assessment Score and Evaluation of the Sepsis-3 Definitions in Critically Ill Children. JAMA Pediatr. 2017 Oct 2;171(10):e172352. doi: 10.1001/jamapediatrics.2017.2352. Epub 2017 Oct 2.
- Zhi HJ, Zhao J, Nie S, Ma YJ, Cui XY, Zhang M, Li Y. Semiquantitative Power Doppler Ultrasound Score to Predict Acute Kidney Injury in Patients With Sepsis or Cardiac Failure: A Prospective Observational Study. J Intensive Care Med. 2021 Jan;36(1):115-122. doi: 10.1177/0885066619887333. Epub 2019 Nov 13.
- Deja A, Skrzypczyk P, Nowak M, Wronska M, Szyszka M, Ofiara A, Lesiak-Kosmatka J, Stelmaszczyk-Emmel A, Panczyk-Tomaszewska M. Evaluation of Active Renin Concentration in A Cohort of Adolescents with Primary Hypertension. Int J Environ Res Public Health. 2022 May 13;19(10):5960. doi: 10.3390/ijerph19105960.
- Stanski NL, Pode Shakked N, Zhang B, Cvijanovich NZ, Fitzgerald JC, Jain PN, Schwarz AJ, Nowak J, Weiss SL, Allen GL, Thomas NJ, Haileselassie B, Goldstein SL. Serum renin and prorenin concentrations predict severe persistent acute kidney injury and mortality in pediatric septic shock. Pediatr Nephrol. 2023 Sep;38(9):3099-3108. doi: 10.1007/s00467-023-05930-0. Epub 2023 Mar 20.
- Sanchez-Pinto LN, Bennett TD, DeWitt PE, Russell S, Rebull MN, Martin B, Akech S, Albers DJ, Alpern ER, Balamuth F, Bembea M, Chisti MJ, Evans I, Horvat CM, Jaramillo-Bustamante JC, Kissoon N, Menon K, Scott HF, Weiss SL, Wiens MO, Zimmerman JJ, Argent AC, Sorce LR, Schlapbach LJ, Watson RS; Society of Critical Care Medicine Pediatric Sepsis Definition Task Force; Biban P, Carrol E, Chiotos K, Flauzino De Oliveira C, Hall MW, Inwald D, Ishimine P, Levin M, Lodha R, Nadel S, Nakagawa S, Peters MJ, Randolph AG, Ranjit S, Souza DC, Tissieres P, Wynn JL. Development and Validation of the Phoenix Criteria for Pediatric Sepsis and Septic Shock. JAMA. 2024 Jan 21. doi: 10.1001/jama.2024.0196. Online ahead of print.
- Menon K, Schlapbach LJ, Akech S, Argent A, Biban P, Carrol ED, Chiotos K, Jobayer Chisti M, Evans IVR, Inwald DP, Ishimine P, Kissoon N, Lodha R, Nadel S, Oliveira CF, Peters M, Sadeghirad B, Scott HF, de Souza DC, Tissieres P, Watson RS, Wiens MO, Wynn JL, Zimmerman JJ, Sorce LR; Pediatric Sepsis Definition Taskforce of the Society of Critical Care Medicine. Criteria for Pediatric Sepsis-A Systematic Review and Meta-Analysis by the Pediatric Sepsis Definition Taskforce. Crit Care Med. 2022 Jan 1;50(1):21-36. doi: 10.1097/CCM.0000000000005294.
- Basu RK, Kaddourah A, Goldstein SL; AWARE Study Investigators. Assessment of a renal angina index for prediction of severe acute kidney injury in critically ill children: a multicentre, multinational, prospective observational study. Lancet Child Adolesc Health. 2018 Feb;2(2):112-120. doi: 10.1016/S2352-4642(17)30181-5.
- Goswami E, Ogden RK, Bennett WE, Goldstein SL, Hackbarth R, Somers MJG, Yonekawa K, Misurac J. Evidence-based development of a nephrotoxic medication list to screen for acute kidney injury risk in hospitalized children. Am J Health Syst Pharm. 2019 Oct 30;76(22):1869-1874. doi: 10.1093/ajhp/zxz203.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 24, 2024
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
February 8, 2024
First Submitted That Met QC Criteria
March 5, 2024
First Posted (Actual)
March 6, 2024
Study Record Updates
Last Update Posted (Actual)
March 6, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Kidney Diseases
- Urologic Diseases
- Systemic Inflammatory Response Syndrome
- Inflammation
- Renal Insufficiency
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Sepsis
- Toxemia
- Wounds and Injuries
- Acute Kidney Injury
Other Study ID Numbers
- 20-0229-CCMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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