Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 10:53 PM
Study NCT ID:
NCT06295393
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renin Angiotensin Aldosterone System In Septic Kids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2024-02-08', 'studyFirstSubmitQcDate': '2024-03-05', 'lastUpdatePostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'description': 'Comparison between healthy and septic subjects serum renin levels'}], 'secondaryOutcomes': [{'measure': 'Aberrations in the renin angiotensin aldosterone system (RAAS) in sepsis associated acute kidney injury', '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.', 'description': 'Comparison of RAAS components between sepsis with and without AKI'}, {'measure': 'Septic induced kidney injury will be associated with alterations in renal blood flow', '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.', 'description': 'Ultrasound will measure blood flow to kidneys during sepsis and compare with serum levels of RAAS'}, {'measure': 'Aberrations in the renin angiotensin aldosterone system (RAAS) in sepsis versus healthy patients', 'timeFrame': '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.', 'description': 'Comparison of RAAS components between sepsis and healthy'}, {'measure': 'Changes in the components of the RAAS over the first three days in sepsis', 'timeFrame': '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.', 'description': 'Measuring components of RAAS over three days and comparing trend'}, {'measure': 'Changes in renal blood flow on Ultrasound 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.', 'description': 'Measuring renal blood flow trend over first three days of sepsis'}, {'measure': 'Renal blood flow and RAAS 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: 72-94hours.', 'description': 'Comparison between blood flow by renal ultrasound and components of RAAS'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis', 'Acute Kidney Injury Due to Sepsis', 'Acute Kidney Injury (Nontraumatic)']}, 'referencesModule': {'references': [{'pmid': '31722600', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35627493', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '36939916', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '38245897', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28783810', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '34612847', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30675420', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30035208', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '31665764', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Prospective observational cohort study; pediatric sepsis vs. healthy pediatric subjects and pediatric sepsis with acute kidney injury (AKI) vs without AKI.\n\nBlood samples and renal ultrasound will be collected on sequential days for septic subject and one time for the healthy patients.\n\nEnzyme-linked immunosorbent assays (ELISA) with be run on serum plasma to compare the renin-angiotensin-aldosterone system (RAAS) between groups.', 'detailedDescription': 'Prospective observational cohort study; pediatric sepsis vs. healthy pediatric subjects and pediatric sepsis with AKI vs without AKI.\n\nPowered 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.\n\nSepsis identified as pediatric Sequential Organ Failure Assessment (pSOFA) \\>/= 2 + infection and/or Phoenix sepsis criteria.\n\nCollecting blood samples on subsequent days of hospitalization. For healthy patients, a one-time blood draw will be obtained .\n\nRenal ultrasound will be performed on day 1, 2 and 3 of hospitalization.\n\nBlood will be collected and plasma stored at -80 degrees Celsius.\n\nPlasma thawed in batches and ELISAs for RAAS components.\n\nDemographic data will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric subjects, age 1 day to 18 years. Septic cohort will meet criteria for sepsis (pSOFA \\>/= 2 or Phoenix criteria) and healthy cohort.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pediatric patients age 1 days - 18 years old with sepsis or age 1 day - 18 years and healthy.\n\nExclusion Criteria:\n\n* -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'}, 'identificationModule': {'nctId': 'NCT06295393', 'acronym': 'RISK', 'briefTitle': 'Renin Angiotensin Aldosterone System In Septic Kids', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Early Identification of Sepsis-associated Acute Kidney Injury Using Ultrasonography Measurements and Renin and Angiotensin Levels in Children and Adults.', 'orgStudyIdInfo': {'id': '20-0229-CCMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric Septic', 'description': '1 day -18 year olds admitted to the ICU meeting criteria for sepsis define as pSOFA \\>/= 2 and/or Phoenix score.'}, {'label': 'Healthy', 'description': '1 day - 18 year old; healthy outpatient'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11004', 'city': 'New Hyde Park', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Grace Fisler, MD', 'role': 'CONTACT', 'email': 'gfisler@northwell.edu'}, {'name': 'Shannon A Moriarty', 'role': 'CONTACT', 'email': 'smoriarty2@northwell.edu', 'phone': '631-834-0984'}], 'facility': "Cohen Children's Medical Center", 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}], 'centralContacts': [{'name': 'Grace Fisler, MD', 'role': 'CONTACT', 'email': 'gfisler@northwell.edu', 'phone': '203-671-0654'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}