SepsisRISKNCT06295393

Renin Angiotensin Aldosterone System In Septic Kids

An observational study of Sepsis and Acute Kidney Injury Due to Sepsis, run by Northwell Health at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 1 day to 18 yearsHealthy volunteers can take part
Conditions the study is for: Sepsis, Acute Kidney Injury Due to Sepsis, Acute Kidney Injury (Nontraumatic)
How many people: 74 participants
Where: 1 siteUnited States
Study dates: 24 Jan 2024to 1 Jun 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 day to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

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.

Who may be able to join

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

Who cannot join

-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

Trial locations and contacts

1 site in 1 country.

Grace Fisler, MD contact

203-671-0654

gfisler@northwell.edu

United States1 site, 1 recruiting

Cohen Children's Medical Center
New Hyde Park, New York, 11004
Grace Fisler, MD, gfisler@northwell.edu
Shannon A Moriarty, 631-834-0984, smoriarty2@northwell.edu
Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Sepsis, Acute Kidney Injury Due to Sepsis, Acute Kidney Injury (Nontraumatic)
Medical subject headings: Sepsis, Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06295393
Study group	Role	What they receive
Pediatric Septic		1 day -18 year olds admitted to the ICU meeting criteria for sepsis define as pSOFA >/= 2 and/or Phoenix score.
Healthy		1 day - 18 year old; healthy outpatient

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in serum renin in sepsis
Comparison between healthy and septic subjects serum renin levels
Measured: 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 outcomes (6)

Aberrations in the renin angiotensin aldosterone system (RAAS) in sepsis associated acute kidney injury
Comparison of RAAS components between sepsis with and without AKI
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Changes in renal blood flow on Ultrasound in Sepsis
Measuring renal blood flow trend over first three days of sepsis
Measured: 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
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jan 20241 Jun 2025

First posted6 Mar 2024
Study start24 Jan 2024
Primary completion1 Jun 2025 (estimated)
Study completion1 Jun 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for SepsisStudies of the same condition, open and under way.
More trials run by Northwell HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 74 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06295393
Sponsor's protocol ID: 20-0229-CCMC
Acronym: RISK
Status last verified: Mar 2024
First submitted: 8 Feb 2024
Last updated: 6 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 31722600
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.
PubMed 35627493
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.
PubMed 36939916
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 Feb 27;331(8):675-686. doi: 10.1001/jama.2024.0196.
PubMed 38245897
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.
PubMed 28783810
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.
PubMed 34612847
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.
PubMed 30675420
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.
PubMed 30035208
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.
PubMed 31665764

Want to know more?

Grace Fisler, MD

203-671-0654

gfisler@northwell.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Identification of Sepsis-associated Acute Kidney Injury Using Ultrasonography Measurements and Renin and Angiotensin Levels in Children and Adults.
ClinicalTrials.gov ID: NCT06295393
Acronym / sponsor ID: RISK / 20-0229-CCMC
Conditions: Sepsis, Acute Kidney Injury Due to Sepsis, Acute Kidney Injury (Nontraumatic)
Study type: Observational
Recruitment status: Unknown status
Enrolment: 74 participants (estimated)
Lead sponsor: Northwell HealthUniversity, hospital or other
Study start: 24 Jan 2024 (actual)
Primary completion: 1 Jun 2025 (estimated)
Study completion: 1 Jun 2025 (estimated)
First posted: 6 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Pediatric Septic	–	–1 day -18 year olds admitted to the ICU meeting criteria for sepsis define as pSOFA >/= 2 and/or Phoenix score.
Healthy	–	–1 day - 18 year old; healthy outpatient

Who may qualify

Ages: 1 day to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult
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.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

-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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

6 secondary outcomes

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.
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.
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.
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.
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.
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.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
Background: PubMed 31722600Zhi 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.
Background: PubMed 35627493Deja 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.
Background: PubMed 36939916Stanski 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.
Background: PubMed 38245897Sanchez-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 Feb 27;331(8):675-686. doi: 10.1001/jama.2024.0196.
Background: PubMed 28783810Matics 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.
Background: PubMed 34612847Menon 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.
Background: PubMed 30675420Kidney 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.
Background: PubMed 30035208Basu 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.
Background: PubMed 31665764Goswami 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Grace Fisler, MD contact

203-671-0654

gfisler@northwell.edu

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Sepsis and Acute Kidney Injury Due to Sepsis, run by Northwell Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Grace Fisler, MD (203-671-0654, gfisler@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06295393, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.