Assessment of Microvascular Circulation in the Pediatric Cardiac Surgery Patient
NCT ID: NCT07184476
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
40 participants
OBSERVATIONAL
2025-09-29
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Primary Tetrology of Fallot repair
Cyanotic physiology with Tetrology of Fallot w/pulmonary stenosis or atresia
No interventions assigned to this group
Primary ventricular septal defect repair (VSD)
Acyanotic lesion with VSD repair patch graft
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Day
17 Years
ALL
No
Sponsors
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Boston Children's Hospital
OTHER
Responsible Party
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Sitaram Emani
Associate Professor of Surgery, Harvard Medical School
References
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Mukaida H, Matsushita S, Kuwaki K, Inotani T, Minami Y, Saigusa A, Amano A. Time-dose response of oxygen delivery during cardiopulmonary bypass predicts acute kidney injury. J Thorac Cardiovasc Surg. 2019 Aug;158(2):492-499. doi: 10.1016/j.jtcvs.2018.10.148. Epub 2018 Nov 16.
Favia I, Garisto C, Rossi E, Picardo S, Ricci Z. Fluid management in pediatric intensive care. Contrib Nephrol. 2010;164:217-226. doi: 10.1159/000313733. Epub 2010 Apr 20.
Massey MJ, Larochelle E, Najarro G, Karmacharla A, Arnold R, Trzeciak S, Angus DC, Shapiro NI. The microcirculation image quality score: development and preliminary evaluation of a proposed approach to grading quality of image acquisition for bedside videomicroscopy. J Crit Care. 2013 Dec;28(6):913-7. doi: 10.1016/j.jcrc.2013.06.015. Epub 2013 Aug 21.
Erdem O, de Graaff JC, Hilty MP, Kraemer US, de Liefde II, van Rosmalen J, Ince C, Tibboel D, Kuiper JW. Microcirculatory Monitoring in Children with Congenital Heart Disease Before and After Cardiac Surgery. J Cardiovasc Transl Res. 2023 Dec;16(6):1333-1342. doi: 10.1007/s12265-023-10407-4. Epub 2023 Jul 14.
Mendelson AA, Lam F, Peirce SM, Murfee WL. Clinical perspectives on the microcirculation. Microcirculation. 2021 Apr;28(3):e12688. doi: 10.1111/micc.12688. No abstract available.
Pediatric Acute Lung Injury Consensus Conference Group. Pediatric acute respiratory distress syndrome: consensus recommendations from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med. 2015 Jun;16(5):428-39. doi: 10.1097/PCC.0000000000000350.
Selewski DT, Cornell TT, Heung M, Troost JP, Ehrmann BJ, Lombel RM, Blatt NB, Luckritz K, Hieber S, Gajarski R, Kershaw DB, Shanley TP, Gipson DS. Validation of the KDIGO acute kidney injury criteria in a pediatric critical care population. Intensive Care Med. 2014 Oct;40(10):1481-8. doi: 10.1007/s00134-014-3391-8. Epub 2014 Jul 31.
Kuiper JW, Tibboel D, Ince C. The vulnerable microcirculation in the critically ill pediatric patient. Crit Care. 2016 Oct 30;20(1):352. doi: 10.1186/s13054-016-1496-x.
Top AP, Ince C, Schouwenberg PH, Tibboel D. Inhaled nitric oxide improves systemic microcirculation in infants with hypoxemic respiratory failure. Pediatr Crit Care Med. 2011 Nov;12(6):e271-4. doi: 10.1097/PCC.0b013e31820ac0b3.
Watchorn JC, Fargaly H, Gilani M, Assadi J, Deitchman AR, Naumann DN, Wollborn J, Goebel U, McCurdy MT, Hutchings SD. The Reproducibility of the Point of Care Microcirculation (POEM) Score When Used to Assess Critically Ill Patients: A Multicenter Prospective Observational Study. Shock. 2020 Jul;54(1):15-20. doi: 10.1097/SHK.0000000000001474.
Gilbert-Kawai E, Coppel J, Bountziouka V, Ince C, Martin D; Caudwell Xtreme Everest and Xtreme Everest 2 Research Groups. A comparison of the quality of image acquisition between the incident dark field and sidestream dark field video-microscopes. BMC Med Imaging. 2016 Jan 21;16:10. doi: 10.1186/s12880-015-0078-8.
Alten JA, Klugman D, Raymond TT, Cooper DS, Donohue JE, Zhang W, Pasquali SK, Gaies MG. Epidemiology and Outcomes of Cardiac Arrest in Pediatric Cardiac ICUs. Pediatr Crit Care Med. 2017 Oct;18(10):935-943. doi: 10.1097/PCC.0000000000001273.
Scolletta S, Marianello D, Isgro G, Dapoto A, Terranova V, Franchi F, Baryshnikova E, Carlucci C, Ranucci M. Microcirculatory changes in children undergoing cardiac surgery: a prospective observational study. Br J Anaesth. 2016 Aug;117(2):206-13. doi: 10.1093/bja/aew187.
Buijs EA, Verboom EM, Top AP, Andrinopoulou ER, Buysse CM, Ince C, Tibboel D. Early microcirculatory impairment during therapeutic hypothermia is associated with poor outcome in post-cardiac arrest children: a prospective observational cohort study. Resuscitation. 2014 Mar;85(3):397-404. doi: 10.1016/j.resuscitation.2013.10.024. Epub 2013 Nov 5.
Akin S, Dos Reis Miranda D, Caliskan K, Soliman OI, Guven G, Struijs A, van Thiel RJ, Jewbali LS, Lima A, Gommers D, Zijlstra F, Ince C. Functional evaluation of sublingual microcirculation indicates successful weaning from VA-ECMO in cardiogenic shock. Crit Care. 2017 Oct 26;21(1):265. doi: 10.1186/s13054-017-1855-2.
Aksu U, Yavuz-Aksu B, Goswami N. Microcirculation: Current Perspective in Diagnostics, Imaging, and Clinical Applications. J Clin Med. 2024 Nov 10;13(22):6762. doi: 10.3390/jcm13226762.
Hilty MP, Guerci P, Ince Y, Toraman F, Ince C. MicroTools enables automated quantification of capillary density and red blood cell velocity in handheld vital microscopy. Commun Biol. 2019 Jun 19;2:217. doi: 10.1038/s42003-019-0473-8. eCollection 2019.
Ince C, Boerma EC, Cecconi M, De Backer D, Shapiro NI, Duranteau J, Pinsky MR, Artigas A, Teboul JL, Reiss IKM, Aldecoa C, Hutchings SD, Donati A, Maggiorini M, Taccone FS, Hernandez G, Payen D, Tibboel D, Martin DS, Zarbock A, Monnet X, Dubin A, Bakker J, Vincent JL, Scheeren TWL; Cardiovascular Dynamics Section of the ESICM. Second consensus on the assessment of sublingual microcirculation in critically ill patients: results from a task force of the European Society of Intensive Care Medicine. Intensive Care Med. 2018 Mar;44(3):281-299. doi: 10.1007/s00134-018-5070-7. Epub 2018 Feb 6.
Dilken O, Ergin B, Ince C. Assessment of sublingual microcirculation in critically ill patients: consensus and debate. Ann Transl Med. 2020 Jun;8(12):793. doi: 10.21037/atm.2020.03.222.
Related Links
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Braedius Medical Cytocam Microcirculation camera website
Other Identifiers
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IRB-P00050326
Identifier Type: -
Identifier Source: org_study_id
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