Dysfunction of the lungs after open heart surgery.
Conditions
Interventions
Trade Name: Custodiol HTK Solution (Histidine-tryptophan-ketoglutarate)
Product Name: Custodiol HTK Solution
Product Code: SKS-kode 1301341
Pharmaceutical Form: Solution for perfusion of organs
INN or
Sponsors
Copenhagen University Hospital Rigshospitalet, The Heart Center - Department of Thoracic Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Planned and urgent surgery on legally competent patients over 18 years: - Coronary Artery Bypass Graft Surgery - Aortic Valve Replacement - Coronary Artery Bypass Graft Surgery + Aortic Valve Replacement - Transcatheter Aortic-Valve Implantation 2) Spirometry FEV1 measurement show less than or equal to 80% of the anticipated. We expect that these patients provide the largest signal with lung protective interventions in relation to lung healthy patients. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: - Previous surgery on the heart or lungs - Previous thoracic irradiation - Preoperative heart failure (ejection fraction below 20%). - Surgical demanding mitral regurgitation - Unstable patients (heart rate above 100 and systolic blood pressure below 100 mmHg) - Intubated patients - Patients with an ongoing preoperative treatment with antibiotics for suspected pneumonia. - Patients with renal insufficiency requiring hemodialysis - Pregnant and lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether patients with a preoperative reduced pulmonary function have a better preserved oxygenation capacity after open heart surgery, using either pulmonary perfusion or pulmoplegia compared with TAVI and the control-group with standard ECC (Extra Corporal Circulation).;Secondary Objective: - To investigate whether there is a difference in the postoperative oxygenation capacity in patients undergoing TAVI compared to open heart surgery, and to what extent this is due to the absence of the ECC triggered inflammatory response or a heart pump failure. - To investigate by an open lung biopsy, if there is a difference between the intervention groups compared to the TAVI and control group in the thickness of the wall and hence surface area of the alveoli as a cause of reduced oxygenation capacity. - Measuring, via a catheter placed in the right and the left atrium, the post-operative arterio-venous difference (AV difference) of the degree of activated alveolar macrophages (AMACs), white blood cells and other relevant inflammatory mediators of the intervention groups compared to TAVI and the control group, and biochemical analysis of differences in the inflammatory response of respectively the systemic and pulmonary circuit. ;Primary end point(s): Selective pulmonary artery perfusion with oxygenated blood or pulmoplegia with Custodiol ® under the ECC can improve postoperative pulmonary function defined by the oxygenation index (OI) in patients that prior to open heart surgery have a reduced lung function (FEV1 below 80% of expected).;Timepoint(s) of evaluation of this end point: The trial is initiated June 2012. We will in the initial phase include 2 patients per week. When the logistics of the experiment is in place, and whit staff recruitment, will the inclusion rate increase to 4 patients per week. It is envisaged to include a total of 120 patients and complete their follow-up over a period of 1 1/2 years. The experiment is expected to b | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Intubation time is shortened in patients undergoing open heart surgery, when pulmonary perfusion or pulmoplegia is used intra-operatively compared to the control group, receiving ECC using current practice. - LOS ICU (Intensive Care Unit Length of Stay) will be reduced in patients undergoing open heart surgery, when used pulmonary perfusion or pulmoplegia intra-operatively compared to the control group with standard ECC. - TAVI patients have a better preserved postoperative lung function compared with the control group, since the lack of ECC gives a reduced immunological response. - The inflammatory response, including the degree of activation AMAC, is reduced in patients undergoing open heart surgery, when pulmonary perfusion or pulmoplegia i used intra-operatively compared to the control group with standard ECC. - The degree of uncoupling of oxidative phosphorylation in the mitochondria is reduced with use of pulmonary perfusion or pulmoplegia under the ECC, when compared with the control group.;Timepoint(s) of evaluation of this end point: The trial is initiated June 2012. We will in the initial phase include 2 patients per week. When the logistics of the experiment is in place, and whit staff recruitment, will the inclusion rate increase to 4 patients per week. It is envisaged to include a total of 120 patients and complete their follow-up over a period of 1 1/2 years. The experiment is expected to be complete in September 2014, and time point of evaluation of end points September 2015. | — |
Countries
Denmark
Contacts
Public ContactKatrine Bredahl Buggeskov
Copenhagen University Hospital Rigshospitalet, The Heart Center - Department of Thoracic Anaesthesiology
Outcome results
None listed