| February 14, 2008 |
| February 22, 2008 |
| January 2005 |
| January 2007 (final data collection date for primary outcome measure) |
- Myocardial Hsp72 protein [ Time Frame: Intra-operative (During CABG) ] [ Designated as safety issue: No ]
- Myocardial eNOS protein [ Time Frame: Intra-Operative (During CABG) ] [ Designated as safety issue: No ]
- Serum Troponin-T [ Time Frame: Peri-operative ] [ Designated as safety issue: No ]
- Serum soluble ICAM-1 [ Time Frame: Peri-operative ] [ Designated as safety issue: No ]
- Serum soluble PSGL-1 [ Time Frame: Peri-operative ] [ Designated as safety issue: No ]
- Serum soluble P-Selectin [ Time Frame: Peri-operative ] [ Designated as safety issue: No ]
- Serum soluble E-Selectin [ Time Frame: Peri-operative ] [ Designated as safety issue: No ]
|
| Same as current |
| Complete list of historical versions of study NCT00623142 on ClinicalTrials.gov Archive Site |
- All cardiovascular haemodynamic parameters as measured by a pulmonary artery catheter [ Time Frame: Peri-operative ] [ Designated as safety issue: No ]
- Duration of mechanical ventilation [ Time Frame: Post Operative ] [ Designated as safety issue: No ]
- Duration of endotracheal intubation [ Time Frame: post operative ] [ Designated as safety issue: No ]
- Length of stay in ICU [ Time Frame: Post-operative ] [ Designated as safety issue: No ]
- Blood loss [ Time Frame: Post operative ] [ Designated as safety issue: No ]
- Inotrope usage [ Time Frame: Post operative ] [ Designated as safety issue: No ]
- Atrial Fibrillation [ Time Frame: Post operative ] [ Designated as safety issue: No ]
- Low cardiac output status [ Time Frame: Post operative ] [ Designated as safety issue: No ]
- Pulmonary complications [ Time Frame: Post operative ] [ Designated as safety issue: No ]
- Renal Complications [ Time Frame: Post operative ] [ Designated as safety issue: No ]
- Cerebrovascular complications [ Time Frame: Post operative ] [ Designated as safety issue: No ]
- Gastrointestinal complications [ Time Frame: Post operative ] [ Designated as safety issue: No ]
- Wound complications [ Time Frame: Post operative ] [ Designated as safety issue: No ]
- Cost of ICU stay [ Time Frame: Post operative ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| The Protective Effects Of Treatment With Hyperbaric Oxygen Prior To Bypass Heart Surgery |
| The Effects of Hyperbaric Oxygen Preconditioning On Cardiovascular Protection & Ischemic Reperfusion Injury |
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. |
| |
| Phase I, Phase II |
| Interventional |
| Health Services Research, Randomized, Single Blind (Caregiver), Parallel Assignment, Safety/Efficacy Study |
- Myocardial Reperfusion Injury
- Cytoprotection
|
| Drug: Hyperbaric Oxygen |
- No Intervention: Patients in this arm were not treated with HBO prior to CABG
- Experimental: Patients in this arm were treated with HBO prior to CABG
|
- 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. 2007 Oct 11; [Epub ahead of print]
- 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. Review.
- 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. Review.
|
| |
| Completed |
| 81 |
| January 2008 |
| January 2007 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 20 Years to 85 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United Kingdom |
| |
| NCT00623142 |
| Dr. Jeysen Zivan Yogaratnam, Hull & East Yorkshire NHS Trust |
| R0047, 04/Q1104/26 |
| Hull and East Yorkshire Hospitals NHS Trust |
| North of England Medical & Hyperbaric Services |
| Principal Investigator: |
Jeysen Z Yogaratnam, MB.BCh, BAO, MRCS |
Hull & East Yorkshire NHS Trust (Castle Hill Hospital), United Kingdom |
|
|
| Hull and East Yorkshire Hospitals NHS Trust |
| January 2008 |