Clinical trial NCT00623142: The Protective Effects Of Treatment With Hyperbaric Oxygen Prior To Bypass Heart Surgery
Official title: The Effects of Hyperbaric Oxygen Preconditioning On Cardiovascular Protection & Ischemic Reperfusion Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myocardial Reperfusion Injury
Cytoprotection
Keywords: Myocardial protection
Ischemic Reperfusion Injury
Hyperbaric Oxygen
Preconditioning
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: North of England Medical & Hyperbaric Services
First posted: 2008-02-25
Enrollment: 81
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study was to determine if treating patients who have coronary heart disease with hyperbaric oxygen (HBO) prior to coronary artery bypass graft (CABG) surgery reduces injury to the heart and vascular system during and after surgery. Furthermore, this study also aims to identify some of the post CABG clinical effects of HBO treatment prior to CABG.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective first time CABG
* Patients with at least 1 vessel coronary artery disease undergoing on- pump CABG

Exclusion Criteria:

* Age ≤ 20 years or ≥ 85 years
* Ejection fraction \< 30%
* Unstable angina
* Recent myocardial infarction (\< 1 month)
* Any additional cardiac disease (e.g. arrythmia, aneurysm, valvular/septal disease, dissection or elevated pulmonary artery pressure)
* Any end stage organ failure (e.g. renal and respiratory failure)
* History of chronic obstructive pulmonary disease (COPD)
* Pneumothorax
* Pulmonary bullae
* Convulsions
* Current history of malignancy
* Severe myopia or intraocular lens
* Patients on K+(ATP) Channel Openers e.g. Nicorandil, Oral Hypoglycemics, Opioid Analgesics, Catecholamines.

Primary outcomes:
measure: Myocardial Hsp72 protein
timeFrame: Intra-operative (During CABG)
measure: Myocardial eNOS protein
timeFrame: Intra-Operative (During CABG)
measure: Serum Troponin-T
timeFrame: Peri-operative
measure: Serum soluble ICAM-1
timeFrame: Peri-operative
measure: Serum soluble PSGL-1
timeFrame: Peri-operative
measure: Serum soluble P-Selectin
timeFrame: Peri-operative
measure: Serum soluble E-Selectin
timeFrame: Peri-operative
Secondary outcomes:
measure: All cardiovascular haemodynamic parameters as measured by a pulmonary artery catheter
timeFrame: Peri-operative
measure: Duration of mechanical ventilation
timeFrame: Post Operative
measure: Duration of endotracheal intubation
timeFrame: post operative
measure: Length of stay in ICU
timeFrame: Post-operative
measure: Blood loss
timeFrame: Post operative
measure: Inotrope usage
timeFrame: Post operative
measure: Atrial Fibrillation
timeFrame: Post operative
measure: Low cardiac output status
timeFrame: Post operative
measure: Pulmonary complications
timeFrame: Post operative
measure: Renal Complications
timeFrame: Post operative
measure: Cerebrovascular complications
timeFrame: Post operative
measure: Gastrointestinal complications
timeFrame: Post operative
measure: Wound complications
timeFrame: Post operative
measure: Cost of ICU stay
timeFrame: Post operative
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Hull & East Yorkshire NHS Trust (Castle Hill Hospital)
state: East Riding Of Yorkshire
Study officials:
affiliation: Hull & East Yorkshire NHS Trust (Castle Hill Hospital), United Kingdom
name: Jeysen Z Yogaratnam, MB.BCh, BAO, MRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yogaratnam JZ, Laden G, Guvendik L, Cowen M, Cale A, Griffin S. Pharmacological preconditioning with hyperbaric oxygen: can this therapy attenuate myocardial ischemic reperfusion injury and induce myocardial protection via nitric oxide? J Surg Res. 2008 Sep;149(1):155-64. doi: 10.1016/j.jss.2007.09.003. Epub 2007 Oct 11.
citation: Yogaratnam JZ, Laden G, Guvendik L, Cowen M, Cale A, Griffin S. Can hyperbaric oxygen be used as adjunctive heart failure therapy through the induction of endogenous heat shock proteins? Adv Ther. 2007 Jan-Feb;24(1):106-18. doi: 10.1007/BF02849998.
citation: Yogaratnam JZ, Laden G, Madden LA, Seymour AM, Guvendik L, Cowen M, Greenman J, Cale A, Griffin S. Hyperbaric oxygen: a new drug in myocardial revascularization and protection? Cardiovasc Revasc Med. 2006 Jul-Sep;7(3):146-54. doi: 10.1016/j.carrev.2006.04.006.
citation: Jeysen ZY, Gerard L, Levant G, Cowen M, Cale A, Griffin S. Research report: the effects of hyperbaric oxygen preconditioning on myocardial biomarkers of cardioprotection in patients having coronary artery bypass graft surgery. Undersea Hyperb Med. 2011 May-Jun;38(3):175-85.
citation: Yogaratnam JZ, Laden G, Guvendik L, Cowen M, Cale A, Griffin S. Hyperbaric oxygen preconditioning improves myocardial function, reduces length of intensive care stay, and limits complications post coronary artery bypass graft surgery. Cardiovasc Revasc Med. 2010 Jan-Mar;11(1):8-19. doi: 10.1016/j.carrev.2009.03.004.