The Effects of Hyperbaric Oxygen Preconditioning On Cardiovascular Protection & Ischemic Reperfusion Injury
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Serum Troponin-T
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- 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 ≤ 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.
Arms & Interventions
B
Patients in this arm were treated with HBO prior to CABG
Intervention: Hyperbaric Oxygen (Drug)
Outcomes
Primary Outcomes
Serum Troponin-T
Time Frame: Peri-operative
Serum soluble PSGL-1
Time Frame: Peri-operative
Serum soluble P-Selectin
Time Frame: Peri-operative
Serum soluble E-Selectin
Time Frame: Peri-operative
Myocardial Hsp72 protein
Time Frame: Intra-operative (During CABG)
Myocardial eNOS protein
Time Frame: Intra-Operative (During CABG)
Serum soluble ICAM-1
Time Frame: Peri-operative
Secondary Outcomes
- Atrial Fibrillation(Post operative)
- Inotrope usage(Post operative)
- Blood loss(Post operative)
- Duration of mechanical ventilation(Post Operative)
- All cardiovascular haemodynamic parameters as measured by a pulmonary artery catheter(Peri-operative)
- Length of stay in ICU(Post-operative)
- Duration of endotracheal intubation(post operative)
- Low cardiac output status(Post operative)
- Pulmonary complications(Post operative)
- Renal Complications(Post operative)
- Cerebrovascular complications(Post operative)
- Gastrointestinal complications(Post operative)
- Wound complications(Post operative)
- Cost of ICU stay(Post operative)