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Completed

NCT Number: NCT00623142

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

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.

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Key information

Conditions

Myocardial Reperfusion Injury Cardiomyopathies Cardiovascular Diseases Cytoprotection Heart Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hull & East Yorkshire NHS Trust (Castle Hill Hospital)

Hull, East Riding Of Yorkshire, HU16 5JQ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyperbaric oxygen

Drug

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 names: Hyperbaric Oxygen Preconditioning

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Collaborators

  • North of England Medical & Hyperbaric Services

Registry information

Official study title

The Effects of Hyperbaric Oxygen Preconditioning On Cardiovascular Protection & Ischemic Reperfusion Injury

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Feb 25, 2008
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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