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Completed

NCT Number: NCT01627756

Continued Ventilation During Cardiopulmonary Bypass

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Debrecen

Debrecen, Nagyerdei krt. 98, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent
  • age > 40 and < 80

Exclusion criteria

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

Treatment and study plan

Lung Ventilation

Other

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.

Non-ventilated Group

Other

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

Primary outcomes

  1. Alteration of soluble ST2 concentration in serum

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

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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Continued Mechanical Ventilation During CABG Operation Attenuates Systemic Immune Modulation

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 26, 2012
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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