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

This study has been completed.
Sponsor:
Collaborator:
North of England Medical & Hyperbaric Services
Information provided by:
Hull and East Yorkshire Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00623142
First received: February 14, 2008
Last updated: February 22, 2008
Last verified: January 2008

February 14, 2008
February 22, 2008
January 2005
January 2007   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00623142 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Health Services Research
  • Myocardial Reperfusion Injury
  • Cytoprotection
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
  • 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
    Intervention: Drug: Hyperbaric Oxygen

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
January 2008
January 2007   (final data collection date for primary outcome measure)

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.
Both
20 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00623142
R0047, 04/Q1104/26
Yes
Dr. Jeysen Zivan Yogaratnam, Hull & East Yorkshire NHS Trust
Hull and East Yorkshire Hospitals NHS Trust
North of England Medical & Hyperbaric Services
Principal Investigator: Jeysen Z Yogaratnam, MB.BCh, BAO, MRCS Hull & East Yorkshire NHS Trust (Castle Hill Hospital), United Kingdom
Hull and East Yorkshire Hospitals NHS Trust
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP