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

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ClinicalTrials.gov Identifier: NCT00623142
Recruitment Status : Completed
First Posted : February 25, 2008
Last Update Posted : February 25, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Myocardial Reperfusion Injury Cytoprotection Drug: Hyperbaric Oxygen Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Health Services Research
Official Title: The Effects of Hyperbaric Oxygen Preconditioning On Cardiovascular Protection & Ischemic Reperfusion Injury
Study Start Date : January 2005
Primary Completion Date : January 2007
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
No Intervention: A
Patients in this arm were not treated with HBO prior to CABG
Experimental: B
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
Other Name: Hyperbaric Oxygen Preconditioning


Outcome Measures

Primary Outcome Measures :
  1. Myocardial Hsp72 protein [ Time Frame: Intra-operative (During CABG) ]
  2. Myocardial eNOS protein [ Time Frame: Intra-Operative (During CABG) ]
  3. Serum Troponin-T [ Time Frame: Peri-operative ]
  4. Serum soluble ICAM-1 [ Time Frame: Peri-operative ]
  5. Serum soluble PSGL-1 [ Time Frame: Peri-operative ]
  6. Serum soluble P-Selectin [ Time Frame: Peri-operative ]
  7. Serum soluble E-Selectin [ Time Frame: Peri-operative ]

Secondary Outcome Measures :
  1. All cardiovascular haemodynamic parameters as measured by a pulmonary artery catheter [ Time Frame: Peri-operative ]
  2. Duration of mechanical ventilation [ Time Frame: Post Operative ]
  3. Duration of endotracheal intubation [ Time Frame: post operative ]
  4. Length of stay in ICU [ Time Frame: Post-operative ]
  5. Blood loss [ Time Frame: Post operative ]
  6. Inotrope usage [ Time Frame: Post operative ]
  7. Atrial Fibrillation [ Time Frame: Post operative ]
  8. Low cardiac output status [ Time Frame: Post operative ]
  9. Pulmonary complications [ Time Frame: Post operative ]
  10. Renal Complications [ Time Frame: Post operative ]
  11. Cerebrovascular complications [ Time Frame: Post operative ]
  12. Gastrointestinal complications [ Time Frame: Post operative ]
  13. Wound complications [ Time Frame: Post operative ]
  14. Cost of ICU stay [ Time Frame: Post operative ]

Eligibility Criteria

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623142


Locations
United Kingdom
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Jeysen Zivan Yogaratnam, Hull & East Yorkshire NHS Trust
ClinicalTrials.gov Identifier: NCT00623142     History of Changes
Other Study ID Numbers: R0047
04/Q1104/26
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: February 25, 2008
Last Verified: January 2008

Keywords provided by Hull and East Yorkshire Hospitals NHS Trust:
Myocardial protection
Ischemic Reperfusion Injury
Hyperbaric Oxygen
Preconditioning

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