Continued Ventilation During Cardiopulmonary Bypass

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hendrik Jan Ankersmit, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01627756
First received: June 19, 2012
Last updated: June 25, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Other: Lung Ventilation
Other: Non-ventilated Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Continued Mechanical Ventilation During CABG Operation Attenuates Systemic Immune Modulation

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Alteration of soluble ST2 concentration in serum [ Time Frame: Preoperative, postoperative, day 1, day 2, day 3, day 4, day 5 after surgery ] [ Designated as safety issue: No ]
    Concentration of soluble ST2 will be assessed in the serum of patient´s preoperativem, postoperative and the following five consecutive days after surgery.


Enrollment: 30
Study Start Date: April 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ventilation Group
Volume controlled ventilation was done during the whole surgery.
Other: Lung 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.
No Intervention: 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
. In the non-ventilated group lungs were collapsed after completion of CPB until after weaning from the extracorporeal circulation.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01627756

Locations
Hungary
Medical University of Debrecen
Debrecen, Hungary, Nagyerdei krt. 98
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Hendrik Jan Ankersmit, MD Medical University of Vienna
  More Information

Publications:

Responsible Party: Hendrik Jan Ankersmit, Assoc. Prof, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01627756     History of Changes
Other Study ID Numbers: 2894-2008
Study First Received: June 19, 2012
Last Updated: June 25, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
Thoracic Surgery
Endotoxins
Respiration, Artificial
Immune System

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014