Cardiac Clinical Trial
— SICSOfficial title:
Evaluation of High-dose Corticosteroids on Microcirculation Alterations in Cardiac Surgery, by FMD (Flow Mediated vasoDilation), Near Infrared Spectrophotometry (NIRS) and Biological Analysis (Syndecan-1)
Cardiac surgery is sometimes associated with organ dysfunction of variable severity (renal
insufficiency, cognitive decline, arrhythmias, ARDS). The phenomenon responsible is an
intense inflammatory reaction induced by cardiopulmonary bypass, leading to microcirculation
alterations, specially in endothelial cell and its protective layer - glycocalyx. Endothelial
dysfunction then reduces the reactivity of peripheral tissues to hypoxia, and is associated
with bad prognosis.
High - dose corticoids administration at anesthesia induction in cardiac surgery could
attenuate the intensity of this inflammatory reaction, and represents the current practice in
our hospital. Nevertheless, this attitude is abandoned in numerous cardiac surgery centres.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | September 2017 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All patients eligible for cardiac surgery Exclusion Criteria: - Age under 18years - Allergy to corticoids - Extreme emergency surgery - Upper member vascular disease |
Country | Name | City | State |
---|---|---|---|
Belgium | Hôpital Erasme | Brussels |
Lead Sponsor | Collaborator |
---|---|
Erasme University Hospital | Jean Paul Van Vooren |
Belgium,
Alley H, Owens CD, Gasper WJ, Grenon SM. Ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery in clinical research. J Vis Exp. 2014 Oct 22;(92):e52070. doi: 10.3791/52070. — View Citation
Barderas R, Mendes M, Torres S, Bartolomé RA, López-Lucendo M, Villar-Vázquez R, Peláez-García A, Fuente E, Bonilla F, Casal JI. In-depth characterization of the secretome of colorectal cancer metastatic cells identifies key proteins in cell adhesion, migration, and invasion. Mol Cell Proteomics. 2013 Jun;12(6):1602-20. doi: 10.1074/mcp.M112.022848. Epub 2013 Feb 26. — View Citation
Cappabianca G, Rotunno C, de Luca Tupputi Schinosa L, Ranieri VM, Paparella D. Protective effects of steroids in cardiac surgery: a meta-analysis of randomized double-blind trials. J Cardiothorac Vasc Anesth. 2011 Feb;25(1):156-65. doi: 10.1053/j.jvca.2010.03.015. Epub 2010 May 26. Review. — View Citation
Chappell D, Jacob M, Hofmann-Kiefer K, Bruegger D, Rehm M, Conzen P, Welsch U, Becker BF. Hydrocortisone preserves the vascular barrier by protecting the endothelial glycocalyx. Anesthesiology. 2007 Nov;107(5):776-84. — View Citation
Cohn SM, Nathens AB, Moore FA, Rhee P, Puyana JC, Moore EE, Beilman GJ; StO2 in Trauma Patients Trial Investigators. Tissue oxygen saturation predicts the development of organ dysfunction during traumatic shock resuscitation. J Trauma. 2007 Jan;62(1):44-54; discussion 54-5. — View Citation
Corretti MC, Anderson TJ, Benjamin EJ, Celermajer D, Charbonneau F, Creager MA, Deanfield J, Drexler H, Gerhard-Herman M, Herrington D, Vallance P, Vita J, Vogel R; International Brachial Artery Reactivity Task Force. Guidelines for the ultrasound assessment of endothelial-dependent flow-mediated vasodilation of the brachial artery: a report of the International Brachial Artery Reactivity Task Force. J Am Coll Cardiol. 2002 Jan 16;39(2):257-65. Erratum in: J Am Coll Cardiol 2002 Mar 20;39(6):1082. — View Citation
Creteur J, Carollo T, Soldati G, Buchele G, De Backer D, Vincent JL. The prognostic value of muscle StO2 in septic patients. Intensive Care Med. 2007 Sep;33(9):1549-56. Epub 2007 Jun 16. — View Citation
De Backer D, Dubois MJ, Schmartz D, Koch M, Ducart A, Barvais L, Vincent JL. Microcirculatory alterations in cardiac surgery: effects of cardiopulmonary bypass and anesthesia. Ann Thorac Surg. 2009 Nov;88(5):1396-403. doi: 10.1016/j.athoracsur.2009.07.002. — View Citation
De Backer D, Durand A. Monitoring the microcirculation in critically ill patients. Best Pract Res Clin Anaesthesiol. 2014 Dec;28(4):441-51. doi: 10.1016/j.bpa.2014.09.005. Epub 2014 Sep 28. — View Citation
Doerschug KC, Delsing AS, Schmidt GA, Haynes WG. Impairments in microvascular reactivity are related to organ failure in human sepsis. Am J Physiol Heart Circ Physiol. 2007 Aug;293(2):H1065-71. Epub 2007 May 4. — View Citation
Fellahi JL, Butin G, Fischer MO, Zamparini G, Gérard JL, Hanouz JL. Dynamic evaluation of near-infrared peripheral oximetry in healthy volunteers: a comparison between INVOS and EQUANOX. J Crit Care. 2013 Oct;28(5):881.e1-6. doi: 10.1016/j.jcrc.2013.05.004. Epub 2013 Jun 13. — View Citation
Gu YJ, Mariani MA, van Oeveren W, Grandjean JG, Boonstra PW. Reduction of the inflammatory response in patients undergoing minimally invasive coronary artery bypass grafting. Ann Thorac Surg. 1998 Feb;65(2):420-4. — View Citation
Kanahara M, Harada H, Katoh A, Ikeda H. New methodological approach to improve reproducibility of brachial artery flow-mediated dilatation. Echocardiography. 2014 Feb;31(2):197-202. doi: 10.1111/echo.12307. Epub 2013 Jul 30. — View Citation
McLay KM, Fontana FY, Nederveen JP, Guida FF, Paterson DH, Pogliaghi S, Murias JM. Vascular responsiveness determined by near-infrared spectroscopy measures of oxygen saturation. Exp Physiol. 2016 Jan;101(1):34-40. doi: 10.1113/EP085406. Epub 2015 Dec 6. Erratum in: Exp Physiol. 2016 Nov 1;101(11):1445. — View Citation
Monthé-Sagan K, Fischer MO, Saplacan V, Gerard JL, Hanouz JL, Fellahi JL. Near-infrared spectroscopy to assess microvascular dysfunction: A prospective pilot study in cardiac surgery patients. J Crit Care. 2016 Feb;31(1):264-8. doi: 10.1016/j.jcrc.2015.09.026. Epub 2015 Oct 9. — View Citation
Nussbaum C, Haberer A, Tiefenthaller A, Januszewska K, Chappell D, Brettner F, Mayer P, Dalla Pozza R, Genzel-Boroviczény O. Perturbation of the microvascular glycocalyx and perfusion in infants after cardiopulmonary bypass. J Thorac Cardiovasc Surg. 2015 Dec;150(6):1474-81.e1. doi: 10.1016/j.jtcvs.2015.08.050. Epub 2015 Aug 24. — View Citation
Panagiotopoulos I, Palatianos G, Michalopoulos A, Chatzigeorgiou A, Prapas S, Kamper EF. Alterations in biomarkers of endothelial function following on-pump coronary artery revascularization. J Clin Lab Anal. 2010;24(6):389-98. doi: 10.1002/jcla.20416. — View Citation
Pätilä T, Kukkonen S, Vento A, Pettilä V, Suojaranta-Ylinen R. Relation of the Sequential Organ Failure Assessment score to morbidity and mortality after cardiac surgery. Ann Thorac Surg. 2006 Dec;82(6):2072-8. — View Citation
Rehm M, Bruegger D, Christ F, Conzen P, Thiel M, Jacob M, Chappell D, Stoeckelhuber M, Welsch U, Reichart B, Peter K, Becker BF. Shedding of the endothelial glycocalyx in patients undergoing major vascular surgery with global and regional ischemia. Circulation. 2007 Oct 23;116(17):1896-906. Epub 2007 Oct 8. — View Citation
Riddington DW, Venkatesh B, Boivin CM, Bonser RS, Elliott TS, Marshall T, Mountford PJ, Bion JF. Intestinal permeability, gastric intramucosal pH, and systemic endotoxemia in patients undergoing cardiopulmonary bypass. JAMA. 1996 Apr 3;275(13):1007-12. — View Citation
Sangalli F, Guazzi M, Senni S, Sala W, Caruso R, Costa MC, Formica F, Avalli L, Fumagalli R. Assessing Endothelial Responsiveness After Cardiopulmonary Bypass: Insights on Different Perfusion Modalities. J Cardiothorac Vasc Anesth. 2015 Aug;29(4):912-6. doi: 10.1053/j.jvca.2014.11.008. Epub 2014 Nov 11. — View Citation
Stoner L, Tarrant MA, Fryer S, Faulkner J. How should flow-mediated dilation be normalized to its stimulus? Clin Physiol Funct Imaging. 2013 Jan;33(1):75-8. doi: 10.1111/j.1475-097X.2012.01154.x. Epub 2012 Jul 25. — View Citation
van Osch D, Dieleman JM, Nathoe HM, Boasson MP, Kluin J, Bunge JJ, Nierich AP, Rosseel PM, van der Maaten JM, Hofland J, Diephuis JC, de Lange F, Boer C, van Dijk D; Dexamethasone for Cardiac Surgery Study Group. Intraoperative High-Dose Dexamethasone in Cardiac Surgery and the Risk of Rethoracotomy. Ann Thorac Surg. 2015 Dec;100(6):2237-42. doi: 10.1016/j.athoracsur.2015.06.025. Epub 2015 Aug 25. — View Citation
Wan S, LeClerc JL, Vincent JL. Inflammatory response to cardiopulmonary bypass: mechanisms involved and possible therapeutic strategies. Chest. 1997 Sep;112(3):676-92. Review. — View Citation
Warren OJ, Watret AL, de Wit KL, Alexiou C, Vincent C, Darzi AW, Athanasiou T. The inflammatory response to cardiopulmonary bypass: part 2--anti-inflammatory therapeutic strategies. J Cardiothorac Vasc Anesth. 2009 Jun;23(3):384-93. doi: 10.1053/j.jvca.2008.09.007. Epub 2008 Dec 3. Review. — View Citation
Whitlock RP, Chan S, Devereaux PJ, Sun J, Rubens FD, Thorlund K, Teoh KH. Clinical benefit of steroid use in patients undergoing cardiopulmonary bypass: a meta-analysis of randomized trials. Eur Heart J. 2008 Nov;29(21):2592-600. doi: 10.1093/eurheartj/ehn333. Epub 2008 Jul 28. Review. — View Citation
Whitlock RP, Devereaux PJ, Teoh KH, Lamy A, Vincent J, Pogue J, Paparella D, Sessler DI, Karthikeyan G, Villar JC, Zuo Y, Avezum Á, Quantz M, Tagarakis GI, Shah PJ, Abbasi SH, Zheng H, Pettit S, Chrolavicius S, Yusuf S; SIRS Investigators. Methylprednisolone in patients undergoing cardiopulmonary bypass (SIRS): a randomised, double-blind, placebo-controlled trial. Lancet. 2015 Sep 26;386(10000):1243-53. doi: 10.1016/S0140-6736(15)00273-1. — View Citation
* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Glycocalyx Biomarker analysis - Syndecan -1 plasmatic concentration assessment | C/ Syndecan - 1 concentration assessment: This molecule is closely linked to glycocalyx and is considered as the most predictive marker of its integrity. Many factors might cause lesions of this structure (inflammation, hyperglycemia, CBP, etc). Its destruction causes further an impairement of endothelial function (vasoconstriction et vasodilation), mediated principally by endothelial factors. Corticoids can be considered as the most effective molecule for glycocalyx protection. Yet we will analyze the plasmatic concentration variation of syndecan - 1 as a glycocalyx marker. Syndecan-1 analysis is performed on frozen plasma by ELISA technique, using specific antibodies (ELISA kit from Ray Biotech, Inc), this method has already been used in previous studies. |
The first analysis will be performed once daily durin 72h | |
Primary | Flow Mediated Vasodilation change | Arterial diameter variation and Doppler flow are measured at brachial artery during vascular occlusion test - viariation of diameter and doppler flow befor and after cuff release will be assessed | 3 measurements of 5 minutes each - vascular occlusion test once daily during 48h. | |
Secondary | StO2 variation change | Tissue oxygen saturation will be assessed by near - infrared spectroscopy (physiological parameter assesment based on spectrophotometry) during vascular occlusion test and after cuff release | 4 measurements of 5 minutes each - vascular occlusion test test once daily during 48h |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04585568 -
Validation of Ballistocardiographic Biosensors and Other Hemodynamic Measures for Healthy Subjects
|
||
Withdrawn |
NCT05084391 -
Phase I/II Randomized Study of Stereotactic Ablative Radiotherapy (SABR) Versus Standard of Care for Refractory Structural Cardiac Arrhythmias (SABR-HEART)
|
Phase 1/Phase 2 | |
Recruiting |
NCT01598766 -
General Investigative MRI Protocol
|
Phase 1 | |
Not yet recruiting |
NCT03047876 -
Brain Vascular Reactivity to Hypothermic Circulatory Arrest With Antegrade Cerebral Perfusion During Aortic Arch Surgery
|
||
Completed |
NCT00639704 -
Improve Nuclear Medicine Heart Imaging, Compare MRI Results With Single Photon Emission Computed Tomography Imaging
|
||
Recruiting |
NCT05297877 -
Use of Artificial Intelligence Cardiac Ultrasound Technology in Teaching Point of Care Cardiac Ultrasound
|
N/A | |
Completed |
NCT04024982 -
TEE Training for Anaesthesiologists
|
N/A | |
Completed |
NCT04096781 -
Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AFib Stroke Prevention
|
N/A | |
Completed |
NCT06453161 -
Pre-operative Exposure to SGLT2 Inhibitors and Post-operative Acute Renal Failure in Cardiac Surgery: a Retrospective Monocentric Cohort Study
|