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.

Abstract

BACKGROUND:

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.

METHODS/DESIGN:

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.

DISCUSSION:

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.

TRIAL REGISTRATION:

ClinicalTrials.gov: NCT01614951.

• Authors: Katrine B Buggeskov, Jørn Wetterslev, Niels H Secher, Lars W Andersen, Thomas Jonassen, Daniel A Steinbrüchel
• Journal: Trials (Trials) Vol. 14 Pg. 30 (Jan 31 2013) ISSN: 1745-6215 [Electronic] England
• PMID: 23363494 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Bretschneider cardioplegic solution
• Mannitol
• Procaine
• Potassium Chloride
• Glucose

Topics

• Cardiac Surgical Procedures (adverse effects)
• Cardiopulmonary Bypass (adverse effects)
• Clinical Protocols
• Glucose (adverse effects, therapeutic use)
• Humans
• Lung (physiopathology)
• Mannitol (adverse effects, therapeutic use)
• Outcome Assessment, Health Care
• Perfusion
• Potassium Chloride (adverse effects, therapeutic use)
• Procaine (adverse effects, therapeutic use)
• Pulmonary Circulation
• Pulmonary Disease, Chronic Obstructive (physiopathology)
• Sample Size
• Systemic Inflammatory Response Syndrome (physiopathology)