CClinicalTrials.gg
Status unknownNCT04678518ECMOUpdated May 19, 2022

Inflammatory Markers Dynamics in Response to Extra-corporeal Membrane Oxygenator Decannulation

An interventional study of Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF in Inflammatory Markers Changes in Response to Extra-corporeal Membrane Oxygenator Decannulation, sponsored by Hamad Medical Corporation. Status unknown at 2 sites in Qatar. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-19.

Sponsored by Hamad Medical Corporation · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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

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Conditions studied

  • Inflammatory Markers Changes in Response to Extra-corporeal Membrane Oxygenator Decannulation
03

In context

Lead sponsor

Hamad Medical Corporation is the lead sponsor of 133 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ALL ECMO patients candidates for decannulation

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    SIRS

    Patients will be grouped according to the presence or absence of SIRS criteria into group I (SIRS)

    Diagnostic Test: Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF

  • Placebo comparator
    NON-SIRS

    Patients will be grouped according to the presence or absence of SIRS criteria into group II (Non-SIRS)

    Diagnostic Test: Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF

Interventions

  • Diagnostic testInflammatory 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)

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 2 years

Other outcomes

  1. Length of stay in ICU

    Time frame: First 48 hours after ECMO initiation

  2. Length of mechanical ventilation

    Time frame: First 48 hours after ECMO initiation

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Study locations

2 of 2 sites recruiting
  • Hamad medical corporation
    Doha, DA 3050, Qatar
    Recruiting
  • Hamad medical corporation
    Doha, DA 3050, Qatar
    Recruiting
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References and documents

Publications

  • 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. PubMed 5060491 ↗
  • 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. PubMed 25303799 ↗
  • Davies MG, Hagen PO. Systemic inflammatory response syndrome. Br J Surg. 1997 Jul;84(7):920-35. doi: 10.1002/bjs.1800840707. PubMed 9240130 ↗
  • 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. PubMed 25940752 ↗
  • 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. PubMed 26063972 ↗
  • 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. PubMed 19901912 ↗
  • 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. PubMed 11044491 ↗
  • 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. PubMed 24329567 ↗
  • 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. PubMed 23628149 ↗
  • 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. PubMed 19054695 ↗
  • 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. PubMed 27425197 ↗
  • 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. PubMed 23379727 ↗
  • 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. PubMed 26842109 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04678518
Lead sponsor
Hamad Medical Corporation
Responsible party
Sponsor
First posted
Dec 22, 2020
Start date
Feb 28, 2023 (estimated)
Primary completion
Oct 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
May 19, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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