Continued Ventilation During Cardiopulmonary Bypass

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT01627756
Collaborator
(none)
30
1
2
16
1.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Lung Ventilation
  • Other: Non-ventilated Group
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Continued Mechanical Ventilation During CABG Operation Attenuates Systemic Immune Modulation
Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Aug 1, 2010
Actual Study Completion Date :
Aug 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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.

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

Outcome Measures

Primary Outcome Measures

  1. Alteration of soluble ST2 concentration in serum [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hendrik Jan Ankersmit, Assoc. Prof, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01627756
Other Study ID Numbers:
  • 2894-2008
First Posted:
Jun 26, 2012
Last Update Posted:
Feb 20, 2020
Last Verified:
Feb 1, 2020
Keywords provided by Hendrik Jan Ankersmit, Assoc. Prof, Medical University of Vienna
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 20, 2020