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

Myocardial Reperfusion Injury Clinical Trial

Official title:

The Effects of Hyperbaric Oxygen Preconditioning On Cardiovascular Protection & Ischemic Reperfusion Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623142
• Other study ID #: R0047
• Secondary ID: 04/Q1104/26
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2005
• Est. completion date: January 2008

Study information

• Verified date: July 2019
• Source: Hull and East Yorkshire Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 2008
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cytoprotection
• Myocardial Reperfusion Injury
• Reperfusion Injury

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Hull & East Yorkshire NHS Trust (Castle Hill Hospital)	Hull	East Riding Of Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Hull and East Yorkshire Hospitals NHS Trust	North of England Medical & Hyperbaric Services

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View 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. Review. — View 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. Epub 2007 Oct 11. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial Hsp72 protein		Intra-operative (During CABG)
Primary	Myocardial eNOS protein		Intra-Operative (During CABG)
Primary	Serum Troponin-T		Peri-operative
Primary	Serum soluble ICAM-1		Peri-operative
Primary	Serum soluble PSGL-1		Peri-operative
Primary	Serum soluble P-Selectin		Peri-operative
Primary	Serum soluble E-Selectin		Peri-operative
Secondary	All cardiovascular haemodynamic parameters as measured by a pulmonary artery catheter		Peri-operative
Secondary	Duration of mechanical ventilation		Post Operative
Secondary	Duration of endotracheal intubation		post operative
Secondary	Length of stay in ICU		Post-operative
Secondary	Blood loss		Post operative
Secondary	Inotrope usage		Post operative
Secondary	Atrial Fibrillation		Post operative
Secondary	Low cardiac output status		Post operative
Secondary	Pulmonary complications		Post operative
Secondary	Renal Complications		Post operative
Secondary	Cerebrovascular complications		Post operative
Secondary	Gastrointestinal complications		Post operative
Secondary	Wound complications		Post operative
Secondary	Cost of ICU stay		Post operative

External Links

•   publication link - Abstract