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Inflammatory Markers Changes in Response to Extra-corporeal Membrane Oxygenator DecannulationECMONCT04678518

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

A study testing Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF in people with Inflammatory Markers Changes in Response to Extra-corporeal Membrane Oxygenator Decannulation, run by Hamad Medical Corporation at 2 sites in Qatar.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
2 sitesQatar
Study dates
28 Feb 2023to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ALL ECMO patients candidates for decannulation

Who cannot join

  • patients who have identified sepsis prior to decannulation, febrile patients, patient who receive steroids and patient who die within 48 hours after ECMO decannulation.

Trial locations and contacts

2 sites in 1 country.

Qatar2 sites, 2 recruiting

  • Hamad medical corporation

    Doha, DA, 3050

    Ossama Bilal, 66480831, obilal@hamad.qa

    Recruiting

  • Hamad medical corporation

    Doha, DA, 3050

    Ossama Bilal, Md, 44395897, obilal@hamad.qa

    Recruiting

Other trials in Qatar

About this study

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

Being tested
Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNFDiagnostic test

    1 hour before decannulation and 3 times after decannulation (1 hours, 12 hours and 24 hours)

Study groups in NCT04678518
Study groupRoleWhat they receive
SIRSActive comparatorPatients will be grouped according to the presence or absence of SIRS criteria into group I (SIRS)
Receives: Diagnostic Test: Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF
NON-SIRSPlacebo comparatorPatients will be grouped according to the presence or absence of SIRS criteria into group II (Non-SIRS)
Receives: Diagnostic Test: Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2020
  2. Study start28 Feb 2023 (estimated)
  3. Primary completion31 Oct 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Single group
Model description
The study will be conducted in the Heart Hospital to be conducted from the time of ethical approval for 24 months. 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.
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04678518
Sponsor's protocol ID
MRC-01-20-155
Acronym
ECMO
Status last verified
May 2022
First submitted
20 Oct 2020
Last updated
19 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

  • Bilal O, Omar AS, Tbishat L, Salama A, Prabhu KS, Uddin S, Kaddoura R, Carr CS, Taha R, Pattath A, Alkhulaifi A. Pro-inflammatory cytokines in response to systemic inflammatory response syndrome post extra-corporeal membrane oxygenator decannulation. Int J Artif Organs. 2026 Jan;49(1):30-38. doi: 10.1177/03913988251398846. Epub 2025 Dec 11.

    PubMed 41383076

Questions about this trial

What is this clinical trial studying?

A study testing Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF in people with Inflammatory Markers Changes in Response to Extra-corporeal Membrane Oxygenator Decannulation, run by Hamad Medical Corporation at 2 sites in Qatar.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cytokine changes (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04678518, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.

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