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CompletedNCT01627756Updated Feb 20, 2020

Continued Ventilation During Cardiopulmonary Bypass

An interventional study of Lung Ventilation and Non-ventilated Group in Coronary Artery Disease, sponsored by Medical University of Vienna. Completed at 1 site in Hungary. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-02-20.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
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Study summary

Cardiopulmonary bypass (CPB) is well known to induce a strong anti-inflammatory response. The investigators examined whether continued mechanical ventilation during CPB alters systemic immune activation.

Read the detailed description

Cardiopulmonary bypass is well known to induce a strong anti-inflammatory response. Studies had been shown that the contact of blood components with artificial surfaces, the surgical trauma, endotoxemia and a reperfusion injury are in part responsible for the seen immunological affect after surgery. The purpose of this study is to test the effect of continued mechanical ventilation during surgery on a blood marker called soluble ST2 in patients sera. Soluble ST2 acts as a decoy receptor of IL-33 and has anti-inflammatory effects. Elevated soluble ST2 concentrations are reported in patients with acute myocardial infarction, sepsis, congestive heart failure and elevates soluble ST2 levels are associated with adverse outcome.

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Conditions studied

  • Coronary Artery Disease

Keywords

  • Thoracic Surgery
  • Endotoxins
  • Respiration, Artificial
  • Immune System
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's enrollment of 30 is below the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

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

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Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Written informed consent
  • age > 40 and \< 80

Exclusion criteria

Exclusion Criteria:

  • treatment with steroids or immunomodulatory interventions during the past four weeks
  • signs of an acute infection
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Ventilation Group

    Volume controlled ventilation was done during the whole surgery.

    Other: Lung Ventilation

  • Active comparator
    Non-ventilation Group

    In the non-ventilated group lungs were collapsed after completion of CPB until after weaning from the extracorporeal circulation.

    Other: Non-ventilated Group

Interventions

  • OtherLung Ventilation

    In the ventilated group, mechanical ventilation was done with the half of the initial tidal volume (i.e. 3-4 ml/kg, 250-300ml) during the aortic cross-clamp.

  • OtherNon-ventilated Group

    . In the non-ventilated group lungs were collapsed after completion of CPB until after weaning from the extracorporeal circulation.

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What researchers measure

Primary outcomes

  1. Alteration of soluble ST2 concentration in serum

    Concentration of soluble ST2 will be assessed in the serum of patient´s preoperativem, postoperative and the following five consecutive days after surgery.

    Time frame: Preoperative, postoperative, day 1, day 2, day 3, day 4, day 5 after surgery

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Study locations

1 site
  • Medical University of Debrecen
    Debrecen, Nagyerdei krt. 98, Hungary
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References and documents

Publications

  • Szerafin T, Niederpold T, Mangold A, Hoetzenecker K, Hacker S, Roth G, Lichtenauer M, Dworschak M, Wolner E, Ankersmit HJ. Secretion of soluble ST2 - possible explanation for systemic immunosuppression after heart surgery. Thorac Cardiovasc Surg. 2009 Feb;57(1):25-9. doi: 10.1055/s-2008-1039044. Epub 2009 Jan 23. PubMed 19169993 ↗
  • Szerafin T, Hoetzenecker K, Hacker S, Horvath A, Pollreisz A, Arpad P, Mangold A, Wliszczak T, Dworschak M, Seitelberger R, Wolner E, Ankersmit HJ. Heat shock proteins 27, 60, 70, 90alpha, and 20S proteasome in on-pump versus off-pump coronary artery bypass graft patients. Ann Thorac Surg. 2008 Jan;85(1):80-7. doi: 10.1016/j.athoracsur.2007.06.049. PubMed 18154785 ↗
  • Szerafin T, Horvath A, Moser B, Hacker S, Hoetzenecker K, Steinlechner B, Brunner M, Roth G, Boltz-Nitulescu G, Peterffy A, Wolner E, Ankersmit HJ. Apoptosis-specific activation markers in on- versus off-pump coronary artery bypass graft (CABG) patients. Clin Lab. 2006;52(5-6):255-61. PubMed 16812952 ↗
  • Szerafin T, Brunner M, Horvath A, Szentgyorgyi L, Moser B, Boltz-Nitulescu G, Peterffy A, Hoetzenecker K, Steinlechner B, Wolner E, Ankersmit HJ. Soluble ST2 protein in cardiac surgery: a possible negative feedback loop to prevent uncontrolled inflammatory reactions. Clin Lab. 2005;51(11-12):657-63. PubMed 16329625 ↗
  • Mildner M, Storka A, Lichtenauer M, Mlitz V, Ghannadan M, Hoetzenecker K, Nickl S, Dome B, Tschachler E, Ankersmit HJ. Primary sources and immunological prerequisites for sST2 secretion in humans. Cardiovasc Res. 2010 Sep 1;87(4):769-77. doi: 10.1093/cvr/cvq104. Epub 2010 Apr 2. PubMed 20363761 ↗
  • Ng CS, Arifi AA, Wan S, Ho AM, Wan IY, Wong EM, Yim AP. Ventilation during cardiopulmonary bypass: impact on cytokine response and cardiopulmonary function. Ann Thorac Surg. 2008 Jan;85(1):154-62. doi: 10.1016/j.athoracsur.2007.07.068. PubMed 18154801 ↗
  • Beer L, Szerafin T, Mitterbauer A, Debreceni T, Maros T, Dworschak M, Roth GA, Ankersmit HJ. Low tidal volume ventilation during cardiopulmonary bypass reduces postoperative chemokine serum concentrations. Thorac Cardiovasc Surg. 2014 Dec;62(8):677-82. doi: 10.1055/s-0034-1387824. Epub 2014 Dec 15. PubMed 25226360 ↗
  • Beer L, Szerafin T, Mitterbauer A, Kasiri MM, Debreceni T Palotas L, Dworschak M, Roth GA, Ankersmit HJ. Ventilation during cardiopulmonary bypass: impact on heat shock protein release. J Cardiovasc Surg (Torino). 2014 Dec;55(6):849-56. Epub 2013 Dec 17. PubMed 24343370 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2020, 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
NCT01627756
Lead sponsor
Medical University of Vienna
Responsible party
Hendrik Jan Ankersmit (Assoc. Prof, Medical University of Vienna) — Principal investigator
First posted
Jun 26, 2012
Start date
Apr 2009
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Feb 20, 2020

Study contacts

Hendrik Jan Ankersmit, MD
principal investigator · Medical University of Vienna

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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