Continued Ventilation During Cardiopulmonary Bypass

Coronary Artery Disease Clinical Trial

Official title:

Continued Mechanical Ventilation During CABG Operation Attenuates Systemic Immune Modulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01627756
• Other study ID #: 2894-2008
• Status: Completed
• Phase: N/A
• Start date: April 2009
• Est. completion date: August 2010

Study information

• Verified date: February 2020
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
Hungary	Medical University of Debrecen	Debrecen

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Hungary, 

References & Publications (6)

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. — View 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. — View Citation

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. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Preoperative, postoperative, day 1, day 2, day 3, day 4, day 5 after surgery