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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04678518
Other study ID # MRC-01-20-155
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 28, 2023
Est. completion date December 31, 2023

Study information

Verified date May 2022
Source Hamad Medical Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Extracorporeal membrane oxygenation (ECMO) aim at providing cardiac, respiratory support, or both. The use of ECMO could be associated with systemic inflammatory response syndrome (SIRS) at the time of initiation or the time of decannulation. There is an existing evidence to state that clinical criteria of SIRS accompany decannulation. We aim at proving this relation through studying the inflammatory markers changes before and after decannulation. The investigators will study all participants who require ECMO support in the heart hospital, all patient will be subjected to clinical evaluation of the SIRS criteria plus studying the inflammatory makers that will include IL1, IL2, IL6 and TNF before and after decannulation. Participants will be divided based on the SIRS criteria into 2 groups and both groups will be compared using Chi-Square analysis (Fisher tests if small sample size) or two tailed t-test, as appropriate


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - ALL ECMO patients candidates for decannulation Exclusion Criteria: - patients who have identified sepsis prior to decannulation, febrile patients, patient who receive steroids and patient who die within 48 hours after ECMO decannulation.

Study Design


Related Conditions & MeSH terms

  • Inflammatory Markers Changes in Response to Extra-corporeal Membrane Oxygenator Decannulation

Intervention

Diagnostic Test:
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)

Locations

Country Name City State
Qatar Hamad medical corporation Doha DA
Qatar Hamad medical corporation Doha DA

Sponsors (1)

Lead Sponsor Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

References & Publications (13)

Davies MG, Hagen PO. Systemic inflammatory response syndrome. Br J Surg. 1997 Jul;84(7):920-35. Review. — View Citation

Graulich J, Walzog B, Marcinkowski M, Bauer K, Kössel H, Fuhrmann G, Bührer 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. — View Citation

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- — View Citation

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. — View Citation

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 rel — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. 2 — View Citation

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. — View Citation

Wang S, Krawiec C, Patel S, Kunselman AR, Song J, Lei F, Baer LD, Ündar A. Laboratory Evaluation of Hemolysis and Systemic Inflammatory Response in Neonatal Nonpulsatile and Pulsatile Extracorporeal Life Support Systems. Artif Organs. 2015 Sep;39(9):774-8 — 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.20 — View Citation

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 S — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Length of stay in ICU First 48 hours after ECMO initiation
Other Length of mechanical ventilation First 48 hours after ECMO initiation
Primary Cytokine changes Cytokines changes: Interleukins (IL); IL1, IL2, IL6 and TNF 1 hour before decannulation and 3 times after decannulation (1 hours, 12 hours and 24 hours) 2 years