Continued Ventilation During Cardiopulmonary Bypass

NCT01627756 | Completed

• 1 other identifier: 2894-2008
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Thoracic Surgery; Endotoxins; Respiration, Artificial; Immune System

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ventilation Group

EXPERIMENTAL

Volume controlled ventilation was done during the whole surgery.

Other: Lung Ventilation

Non-ventilation Group

ACTIVE COMPARATOR

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

Other: Non-ventilated Group

Interventions

Lung Ventilation OTHER

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.

Ventilation Group

Non-ventilated Group OTHER

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

Non-ventilation Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• age \> 40 and \< 80

You may not qualify if:

• treatment with steroids or immunomodulatory interventions during the past four weeks
• signs of an acute infection

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Debrecen

Debrecen, Nagyerdei krt. 98, Hungary

Location

Related Publications (8)

• 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.

  PMID: 19169993 BACKGROUND

• 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.

  PMID: 18154785 BACKGROUND

• 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.

  PMID: 16812952 BACKGROUND

• 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.

  PMID: 16329625 BACKGROUND

• 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.

  PMID: 20363761 BACKGROUND

• 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.

  PMID: 18154801 BACKGROUND

• 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.

  PMID: 25226360 DERIVED

• 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.

  PMID: 24343370 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Respiratory Aspiration

Interventions

Ventilation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Environment, Controlled; Environment; Environment and Public Health

Study Officials

• Hendrik Jan Ankersmit, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 26, 2012
• Study Start: April 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

HU (1)