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Continued Ventilation During Cardiopulmonary Bypass

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Lung Ventilation
Non-ventilated Group
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Coronary Artery Disease focused on measuring Thoracic Surgery, Endotoxins, Respiration, Artificial, Immune System

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Debrecen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ventilation Group

Non-ventilation Group

Arm Description

Volume controlled ventilation was done during the whole surgery.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 19, 2012
Last Updated
February 19, 2020
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01627756
Brief Title
Continued Ventilation During Cardiopulmonary Bypass
Official Title
Continued Mechanical Ventilation During CABG Operation Attenuates Systemic Immune Modulation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Thoracic Surgery, Endotoxins, Respiration, Artificial, Immune System

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ventilation Group
Arm Type
Experimental
Arm Description
Volume controlled ventilation was done during the whole surgery.
Arm Title
Non-ventilation Group
Arm Type
Active Comparator
Arm Description
In the non-ventilated group lungs were collapsed after completion of CPB until after weaning from the extracorporeal circulation.
Intervention Type
Other
Intervention Name(s)
Lung Ventilation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Non-ventilated Group
Intervention Description
. In the non-ventilated group lungs were collapsed after completion of CPB until after weaning from the extracorporeal circulation.
Primary Outcome Measure Information:
Title
Alteration of soluble ST2 concentration in serum
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendrik Jan Ankersmit, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Debrecen
City
Debrecen
ZIP/Postal Code
Nagyerdei krt. 98
Country
Hungary

12. IPD Sharing Statement

Citations:
PubMed Identifier
19169993
Citation
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.
Results Reference
background
PubMed Identifier
18154785
Citation
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.
Results Reference
background
PubMed Identifier
16812952
Citation
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.
Results Reference
background
PubMed Identifier
16329625
Citation
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.
Results Reference
background
PubMed Identifier
20363761
Citation
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.
Results Reference
background
PubMed Identifier
18154801
Citation
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.
Results Reference
background
PubMed Identifier
25226360
Citation
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.
Results Reference
derived
PubMed Identifier
24343370
Citation
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.
Results Reference
derived

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Continued Ventilation During Cardiopulmonary Bypass

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