The Protective Effects Of Treatment With Hyperbaric Oxygen Prior To Bypass Heart Surgery

Phase 1

Completed

• Conditions: Myocardial Reperfusion Injury; Cytoprotection
• Interventions: Drug: Hyperbaric Oxygen

• Registration Number: NCT00623142
• Lead Sponsor: Hull University Teaching Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2007-01
• Study Completion: 2008-01
• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-02-22
• Study First Posted: 2008-02-25
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Hyperbaric Oxygen	Patients in this arm were treated with HBO prior to CABG

Primary Outcome Measures

Name	Time	Method
Serum Troponin-T	Peri-operative
Serum soluble ICAM-1	Peri-operative
Serum soluble PSGL-1	Peri-operative
Serum soluble P-Selectin	Peri-operative
Serum soluble E-Selectin	Peri-operative
Myocardial Hsp72 protein	Intra-operative (During CABG)
Myocardial eNOS protein	Intra-Operative (During CABG)

Secondary Outcome Measures

Name	Time	Method
Blood loss	Post operative
Inotrope usage	Post operative
Atrial Fibrillation	Post operative
Low cardiac output status	Post operative
Pulmonary complications	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
Renal Complications	Post operative
Cerebrovascular complications	Post operative
Gastrointestinal complications	Post operative
Wound complications	Post operative
Cost of ICU stay	Post operative

Trial Locations

Locations (1)

Hull & East Yorkshire NHS Trust (Castle Hill Hospital); 🇬🇧 Hull, East Riding Of Yorkshire, United Kingdom