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The Protective Effects Of Treatment With Hyperbaric Oxygen Prior To Bypass Heart Surgery
This study has been completed.
First Received: February 14, 2008   Last Updated: February 22, 2008   History of Changes
Sponsor: Hull and East Yorkshire Hospitals NHS Trust
Collaborator: 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

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

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy Surgery
U.S. FDA Resources

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     History of Changes
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

Additional relevant MeSH terms:
Pathologic Processes
Heart Diseases
Postoperative Complications
Myocardial Ischemia
Vascular Diseases
 Cardiovascular Diseases
Cardiomyopathies
Myocardial Reperfusion Injury
Reperfusion Injury

ClinicalTrials.gov processed this record on February 04, 2010



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