Inflammatory Markers Dynamics in Response to Extra-corporeal Membrane Oxygenator Decannulation
NCT ID: NCT04678518
Last Updated: 2022-05-19
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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UNKNOWN
NA
30 participants
INTERVENTIONAL
2023-02-28
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
The clinical characterization of post decannulation SIRS when patient fulfill 2 out of 3 criteria, fever (temperature \>38.3 Celsius), leukocytosis (white blood cell \[WBC\] \>12,000, or \> 25% increase from pre-procedure baseline), and need for escalation of vasopressors post decannulation. The rest of SIRS criteria will not be used as it is subjected to changes due to contribution from the inotropes, sedation, pain level and ventilation settings. \[12\] Patients will be grouped according to the presence or absence of SIRS criteria into group I (SIRS) and group II (no-SIRS). Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF 1 hour before decannulation and 3 times after decannulation (1 hours, 12 hours and 24 hours) both groups will be compared.
SCREENING
SINGLE
Study Groups
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SIRS
Patients will be grouped according to the presence or absence of SIRS criteria into group I (SIRS)
Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF
1 hour before decannulation and 3 times after decannulation (1 hours, 12 hours and 24 hours)
NON-SIRS
Patients will be grouped according to the presence or absence of SIRS criteria into group II (Non-SIRS)
Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF
1 hour before decannulation and 3 times after decannulation (1 hours, 12 hours and 24 hours)
Interventions
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Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF
1 hour before decannulation and 3 times after decannulation (1 hours, 12 hours and 24 hours)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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Hamad Medical Corporation
INDUSTRY
Responsible Party
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Locations
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Hamad medical corporation
Doha, DA, Qatar
Hamad medical corporation
Doha, DA, Qatar
Countries
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Facility Contacts
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References
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Hill JD, O'Brien TG, Murray JJ, Dontigny L, Bramson ML, Osborn JJ, Gerbode F. Prolonged extracorporeal oxygenation for acute post-traumatic respiratory failure (shock-lung syndrome). Use of the Bramson membrane lung. N Engl J Med. 1972 Mar 23;286(12):629-34. doi: 10.1056/NEJM197203232861204. No abstract available.
Sauer CM, Yuh DD, Bonde P. Extracorporeal membrane oxygenation use has increased by 433% in adults in the United States from 2006 to 2011. ASAIO J. 2015 Jan-Feb;61(1):31-6. doi: 10.1097/MAT.0000000000000160.
Davies MG, Hagen PO. Systemic inflammatory response syndrome. Br J Surg. 1997 Jul;84(7):920-35. doi: 10.1002/bjs.1800840707.
Wang S, Krawiec C, Patel S, Kunselman AR, Song J, Lei F, Baer LD, Undar A. Laboratory Evaluation of Hemolysis and Systemic Inflammatory Response in Neonatal Nonpulsatile and Pulsatile Extracorporeal Life Support Systems. Artif Organs. 2015 Sep;39(9):774-81. doi: 10.1111/aor.12466. Epub 2015 May 1.
Rungatscher A, Tessari M, Stranieri C, Solani E, Linardi D, Milani E, Montresor A, Merigo F, Salvetti B, Menon T, Faggian G. Oxygenator Is the Main Responsible for Leukocyte Activation in Experimental Model of Extracorporeal Circulation: A Cautionary Tale. Mediators Inflamm. 2015;2015:484979. doi: 10.1155/2015/484979. Epub 2015 May 4.
McILwain RB, Timpa JG, Kurundkar AR, Holt DW, Kelly DR, Hartman YE, Neel ML, Karnatak RK, Schelonka RL, Anantharamaiah GM, Killingsworth CR, Maheshwari A. Plasma concentrations of inflammatory cytokines rise rapidly during ECMO-related SIRS due to the release of preformed stores in the intestine. Lab Invest. 2010 Jan;90(1):128-39. doi: 10.1038/labinvest.2009.119. Epub 2009 Nov 9.
Graulich J, Walzog B, Marcinkowski M, Bauer K, Kossel H, Fuhrmann G, Buhrer C, Gaehtgens P, Versmold HT. Leukocyte and endothelial activation in a laboratory model of extracorporeal membrane oxygenation (ECMO). Pediatr Res. 2000 Nov;48(5):679-84. doi: 10.1203/00006450-200011000-00021.
Shi J, Chen Q, Yu W, Shen J, Gong J, He C, Hu Y, Zhang J, Gao T, Xi F, Li J. Continuous renal replacement therapy reduces the systemic and pulmonary inflammation induced by venovenous extracorporeal membrane oxygenation in a porcine model. Artif Organs. 2014 Mar;38(3):215-23. doi: 10.1111/aor.12154. Epub 2013 Dec 11.
Yimin H, Wenkui Y, Jialiang S, Qiyi C, Juanhong S, Zhiliang L, Changsheng H, Ning L, Jieshou L. Effects of continuous renal replacement therapy on renal inflammatory cytokines during extracorporeal membrane oxygenation in a porcine model. J Cardiothorac Surg. 2013 Apr 29;8:113. doi: 10.1186/1749-8090-8-113.
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. No abstract available.
Thangappan K, Cavarocchi NC, Baram M, Thoma B, Hirose H. Systemic inflammatory response syndrome (SIRS) after extracorporeal membrane oxygenation (ECMO): Incidence, risks and survivals. Heart Lung. 2016 Sep-Oct;45(5):449-53. doi: 10.1016/j.hrtlng.2016.06.004. Epub 2016 Jul 15.
Lamb KM, Hirose H, Cavarocchi NC. Preparation and technical considerations for percutaneous cannulation for veno-arterial extracorporeal membrane oxygenation. J Card Surg. 2013 Mar;28(2):190-2. doi: 10.1111/jocs.12058. Epub 2013 Feb 5.
Shaheen A, Tanaka D, Cavarocchi NC, Hirose H. Veno-Venous Extracorporeal Membrane Oxygenation (V V ECMO): Indications, Preprocedural Considerations, and Technique. J Card Surg. 2016 Apr;31(4):248-52. doi: 10.1111/jocs.12690. Epub 2016 Feb 3.
Other Identifiers
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MRC-01-20-155
Identifier Type: -
Identifier Source: org_study_id
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