Pulmonary perfusion with oxygenated blood or custodiol HTK solution during cardiac surgery for postoperative pulmonary function in COPD patients: a trial protocol for the randomized, clinical, parallel group, assessor and data analyst blinded Pulmonary Protection Trial
<p>Abstract</p> <p>Background</p> <p>Five to thirty percent of patients undergoing cardiac surgery present with chronic obstructive pulmonary disease (COPD) and have a 2- to 10-fold higher 30-day mortality risk. Cardiopulmonary bypass (CPB) creates a whole body systemic...
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| Format: | Article |
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BMC
2013-01-01
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| Series: | Trials |
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| Online Access: | http://www.trialsjournal.com/content/14/1/30 |
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| author | Buggeskov Katrine B Wetterslev Jørn Secher Niels H Andersen Lars W Jonassen Thomas Steinbrüchel Daniel A |
| author_facet | Buggeskov Katrine B Wetterslev Jørn Secher Niels H Andersen Lars W Jonassen Thomas Steinbrüchel Daniel A |
| author_sort | Buggeskov Katrine B |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>Five to thirty percent of patients undergoing cardiac surgery present with chronic obstructive pulmonary disease (COPD) and have a 2- to 10-fold higher 30-day mortality risk. Cardiopulmonary bypass (CPB) creates a whole body systemic inflammatory response syndrome (SIRS) that could impair pulmonary function. Impaired pulmonary function can, however, be attenuated by pulmonary perfusion with oxygenated blood or custodiol HTK (histidine-tryptophan-ketoglutarate) solution.</p> <p>Methods/Design</p> <p>The Pulmonary Protection Trial (PP-Trial) randomizes 90 patients undergoing CPB-dependent cardiac surgery to evaluate whether pulmonary perfusion with oxygenated blood or custodiol HTK solution reduces postoperative pulmonary dysfunction in COPD patients. Further, we aim for a non-randomized evaluation of postoperative pulmonary function after transcatheter aortic-valve implantation (TAVI). The primary outcome measure is the oxygenation index measured from anesthesia induction to the end of surgery and until 24 hours after anesthesia induction for a total of six evaluations.</p> <p>Discussion</p> <p>Patients with COPD may be impaired by hypoxemia and SIRS. Thus, prolonged recovery and even postoperative complications and death may be reflected by the degree of hypoxemia and SIRS. The limited sample size does not aim for confirmatory conclusions on mortality, cardiovascular complications or risk of pneumonia and sepsis, but the PP-Trial is considered an important feasibility trial paving the road for a multicenter confirmatory trial.</p> <p>Trial registration</p> <p>ClinicalTrials.gov: NCT01614951.</p> |
| first_indexed | 2024-04-13T06:23:41Z |
| format | Article |
| id | doaj.art-a0c7458cb5e6492bac3f2608b2087cef |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T06:23:41Z |
| publishDate | 2013-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-a0c7458cb5e6492bac3f2608b2087cef2022-12-22T02:58:32ZengBMCTrials1745-62152013-01-011413010.1186/1745-6215-14-30Pulmonary perfusion with oxygenated blood or custodiol HTK solution during cardiac surgery for postoperative pulmonary function in COPD patients: a trial protocol for the randomized, clinical, parallel group, assessor and data analyst blinded Pulmonary Protection TrialBuggeskov Katrine BWetterslev JørnSecher Niels HAndersen Lars WJonassen ThomasSteinbrüchel Daniel A<p>Abstract</p> <p>Background</p> <p>Five to thirty percent of patients undergoing cardiac surgery present with chronic obstructive pulmonary disease (COPD) and have a 2- to 10-fold higher 30-day mortality risk. Cardiopulmonary bypass (CPB) creates a whole body systemic inflammatory response syndrome (SIRS) that could impair pulmonary function. Impaired pulmonary function can, however, be attenuated by pulmonary perfusion with oxygenated blood or custodiol HTK (histidine-tryptophan-ketoglutarate) solution.</p> <p>Methods/Design</p> <p>The Pulmonary Protection Trial (PP-Trial) randomizes 90 patients undergoing CPB-dependent cardiac surgery to evaluate whether pulmonary perfusion with oxygenated blood or custodiol HTK solution reduces postoperative pulmonary dysfunction in COPD patients. Further, we aim for a non-randomized evaluation of postoperative pulmonary function after transcatheter aortic-valve implantation (TAVI). The primary outcome measure is the oxygenation index measured from anesthesia induction to the end of surgery and until 24 hours after anesthesia induction for a total of six evaluations.</p> <p>Discussion</p> <p>Patients with COPD may be impaired by hypoxemia and SIRS. Thus, prolonged recovery and even postoperative complications and death may be reflected by the degree of hypoxemia and SIRS. The limited sample size does not aim for confirmatory conclusions on mortality, cardiovascular complications or risk of pneumonia and sepsis, but the PP-Trial is considered an important feasibility trial paving the road for a multicenter confirmatory trial.</p> <p>Trial registration</p> <p>ClinicalTrials.gov: NCT01614951.</p>http://www.trialsjournal.com/content/14/1/30Cardiopulmonary bypassInflammationSystemic inflammatory response syndromePulmonary functionPulmonary perfusionPulmoplegiaTranscatheter aortic-valve implantation |
| spellingShingle | Buggeskov Katrine B Wetterslev Jørn Secher Niels H Andersen Lars W Jonassen Thomas Steinbrüchel Daniel A Pulmonary perfusion with oxygenated blood or custodiol HTK solution during cardiac surgery for postoperative pulmonary function in COPD patients: a trial protocol for the randomized, clinical, parallel group, assessor and data analyst blinded Pulmonary Protection Trial Trials Cardiopulmonary bypass Inflammation Systemic inflammatory response syndrome Pulmonary function Pulmonary perfusion Pulmoplegia Transcatheter aortic-valve implantation |
| title | Pulmonary perfusion with oxygenated blood or custodiol HTK solution during cardiac surgery for postoperative pulmonary function in COPD patients: a trial protocol for the randomized, clinical, parallel group, assessor and data analyst blinded Pulmonary Protection Trial |
| title_full | Pulmonary perfusion with oxygenated blood or custodiol HTK solution during cardiac surgery for postoperative pulmonary function in COPD patients: a trial protocol for the randomized, clinical, parallel group, assessor and data analyst blinded Pulmonary Protection Trial |
| title_fullStr | Pulmonary perfusion with oxygenated blood or custodiol HTK solution during cardiac surgery for postoperative pulmonary function in COPD patients: a trial protocol for the randomized, clinical, parallel group, assessor and data analyst blinded Pulmonary Protection Trial |
| title_full_unstemmed | Pulmonary perfusion with oxygenated blood or custodiol HTK solution during cardiac surgery for postoperative pulmonary function in COPD patients: a trial protocol for the randomized, clinical, parallel group, assessor and data analyst blinded Pulmonary Protection Trial |
| title_short | Pulmonary perfusion with oxygenated blood or custodiol HTK solution during cardiac surgery for postoperative pulmonary function in COPD patients: a trial protocol for the randomized, clinical, parallel group, assessor and data analyst blinded Pulmonary Protection Trial |
| title_sort | pulmonary perfusion with oxygenated blood or custodiol htk solution during cardiac surgery for postoperative pulmonary function in copd patients a trial protocol for the randomized clinical parallel group assessor and data analyst blinded pulmonary protection trial |
| topic | Cardiopulmonary bypass Inflammation Systemic inflammatory response syndrome Pulmonary function Pulmonary perfusion Pulmoplegia Transcatheter aortic-valve implantation |
| url | http://www.trialsjournal.com/content/14/1/30 |
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