The Protective Effects Of Treatment With Hyperbaric Oxygen Prior To Bypass Heart Surgery - Full Text View

Sponsors and Collaborators:	Hull and East Yorkshire Hospitals NHS Trust North of England Medical & Hyperbaric Services
Information provided by:	Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier:	NCT00623142

Purpose

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.

Condition	Intervention	Phase
Myocardial Reperfusion Injury Cytoprotection	Drug: Hyperbaric Oxygen	Phase I Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Single Blind (Caregiver), Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effects of Hyperbaric Oxygen Preconditioning On Cardiovascular Protection & Ischemic Reperfusion Injury

Further study details as provided by Hull and East Yorkshire Hospitals NHS Trust:

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)

Arms	Assigned Interventions
A: No Intervention Patients in this arm were not treated with HBO prior to CABG
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

Eligibility

Ages Eligible for Study:	20 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623142

Locations

United Kingdom, East Riding of Yorkshire
Hull & East Yorkshire NHS Trust (Castle Hill Hospital)
Hull, East Riding of Yorkshire, United Kingdom, HU16 5JQ

Sponsors and Collaborators

Hull and East Yorkshire Hospitals NHS Trust

North of England Medical & Hyperbaric Services

Investigators

Principal Investigator:

Jeysen Z Yogaratnam, MB.BCh, BAO, MRCS

Hull & East Yorkshire NHS Trust (Castle Hill Hospital), United Kingdom

More Information

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]

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.

Responsible Party:	Hull & East Yorkshire NHS Trust ( Dr. Jeysen Zivan Yogaratnam )
Study ID Numbers:	R0047, 04/Q1104/26
Study 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

Ischemia
Cardiomyopathies
Myocardial Reperfusion Injury
Reperfusion Injury

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009