Continued Ventilation During Cardiopulmonary Bypass - Full Text View

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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

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

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:

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. Epub 2009 Jan 23.

Szerafin T, Hoetzenecker K, Hacker S, Horvath A, Pollreisz A, Arpád 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.

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.

Szerafin T, Brunner M, Horváth A, Szentgyörgyi L, Moser B, Boltz-Nitulescu G, Péterffy 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.

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. Epub 2010 Apr 2.

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.

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 May 23, 2013