The Protective Effects Of Treatment With Hyperbaric Oxygen Prior To Bypass Heart Surgery
The Effects of Hyperbaric Oxygen Preconditioning On Cardiovascular Protection & Ischemic Reperfusion Injury
2 other identifiers
interventional
81
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2005
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 14, 2008
CompletedFirst Posted
Study publicly available on registry
February 25, 2008
CompletedJuly 15, 2019
July 1, 2019
2 years
February 14, 2008
July 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Myocardial Hsp72 protein
Intra-operative (During CABG)
Myocardial eNOS protein
Intra-Operative (During CABG)
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
Secondary Outcomes (14)
All cardiovascular haemodynamic parameters as measured by a pulmonary artery catheter
Peri-operative
Duration of mechanical ventilation
Post Operative
Duration of endotracheal intubation
post operative
Length of stay in ICU
Post-operative
Blood loss
Post operative
- +9 more secondary outcomes
Study Arms (2)
A
NO INTERVENTIONPatients in this arm were not treated with HBO prior to CABG
B
EXPERIMENTALPatients in this arm were treated with HBO prior to CABG
Interventions
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 Criteria
You may qualify if:
- Patients undergoing elective first time CABG
- Patients with at least 1 vessel coronary artery disease undergoing on- pump CABG
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hull & East Yorkshire NHS Trust (Castle Hill Hospital)
Hull, East Riding Of Yorkshire, HU16 5JQ, United Kingdom
Related Publications (5)
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. doi: 10.1016/j.jss.2007.09.003. Epub 2007 Oct 11.
PMID: 17996900BACKGROUNDYogaratnam 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. doi: 10.1007/BF02849998.
PMID: 17526467BACKGROUNDYogaratnam 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. doi: 10.1016/j.carrev.2006.04.006.
PMID: 16945821BACKGROUNDJeysen 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.
PMID: 21721351BACKGROUNDYogaratnam JZ, Laden G, Guvendik L, Cowen M, Cale A, Griffin S. Hyperbaric oxygen preconditioning improves myocardial function, reduces length of intensive care stay, and limits complications post coronary artery bypass graft surgery. Cardiovasc Revasc Med. 2010 Jan-Mar;11(1):8-19. doi: 10.1016/j.carrev.2009.03.004.
PMID: 20129356DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeysen Z Yogaratnam, MB.BCh, BAO, MRCS
Hull & East Yorkshire NHS Trust (Castle Hill Hospital), United Kingdom
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
February 14, 2008
First Posted
February 25, 2008
Study Start
January 1, 2005
Primary Completion
January 1, 2007
Study Completion
January 1, 2008
Last Updated
July 15, 2019
Record last verified: 2019-07