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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.
Myocardial Reperfusion Injury
Cytoprotection
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Drug: Hyperbaric Oxygen
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Phase I
Phase II
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U.S. FDA Resources
| Study Type: |
Interventional |
| Study Design: |
Health Services Research, Randomized, Single Blind (Caregiver), Parallel Assignment, Safety/Efficacy Study |
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| Official Title: |
The Effects of Hyperbaric Oxygen Preconditioning On Cardiovascular Protection & Ischemic Reperfusion Injury |
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: |
81 |
| Study Start Date: |
January 2005 |
| Study Completion Date: |
January 2008 |
| Primary Completion Date: |
January 2007 (Final data collection date for primary outcome measure) |
| A: No Intervention
Patients in this arm were not treated with HBO prior to CABG |
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| B: Experimental
Patients in this arm were treated with HBO prior to CABG |
Drug: Hyperbaric Oxygen
100% Oxygen at 2.4 ATA for 30 minutes followed by 5 minutes break followed by 100% Oxygen at 2.4 ATA for another 30 minutes. This intervention was given about 4 to 5 hours prior to CABG |
| Ages Eligible for Study: |
20 Years to 85 Years |
| Genders Eligible for Study: |
Both |
| Accepts Healthy Volunteers: |
No |
Inclusion Criteria:
- Patients undergoing elective first time CABG
- Patients with at least 1 vessel coronary artery disease undergoing on- pump CABG
Exclusion Criteria:
- Age %u2264 20 years or %u2265 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623142
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| Hull & East Yorkshire NHS Trust (Castle Hill Hospital) |
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| Hull, East Riding of Yorkshire, United Kingdom, HU16 5JQ |
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| Hull and East Yorkshire Hospitals NHS Trust |
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| North of England Medical & Hyperbaric Services |
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| Principal Investigator: |
Jeysen Z Yogaratnam, MB.BCh, BAO, MRCS |
Hull & East Yorkshire NHS Trust (Castle Hill Hospital), United Kingdom |
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| Hull & East Yorkshire NHS Trust (Castle Hill Hospital) |
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| Hull, East Riding of Yorkshire, United Kingdom, HU16 5JQ |
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| Hull and East Yorkshire Hospitals NHS Trust |
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| North of England Medical & Hyperbaric Services |
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| Principal Investigator: |
Jeysen Z Yogaratnam, MB.BCh, BAO, MRCS |
Hull & East Yorkshire NHS Trust (Castle Hill Hospital), United Kingdom |
Publications:
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]
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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.
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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.
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| Responsible Party: |
Hull & East Yorkshire NHS Trust ( Dr. Jeysen Zivan Yogaratnam ) |
| Study ID Numbers: |
R0047, 04/Q1104/26 |
| First Received: |
February 14, 2008 |
| Last Updated: |
February 22, 2008 |
| ClinicalTrials.gov Identifier: |
NCT00623142 |
| Health Authority: |
United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Hull and East Yorkshire Hospitals NHS Trust:
| Myocardial protection |
| Ischemic Reperfusion Injury |
| Hyperbaric Oxygen |
| Preconditioning | | Study placed in the following topic categories:
| Heart Diseases |
| Postoperative Complications |
| Myocardial Ischemia |
| Vascular Diseases | |
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| Ischemia |
| Cardiomyopathies |
| Myocardial Reperfusion Injury |
| Reperfusion Injury | | Additional relevant MeSH terms:
| Pathologic Processes |
| Myocardial Reperfusion Injury |
| Cardiovascular Diseases | |
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