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

Primary Purpose

Myocardial Reperfusion Injury, Cytoprotection

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Hyperbaric Oxygen
Sponsored by
Hull University Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Myocardial Reperfusion Injury focused on measuring Myocardial protection, Ischemic Reperfusion Injury, Hyperbaric Oxygen, Preconditioning

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hull & East Yorkshire NHS Trust (Castle Hill Hospital)

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

A

B

Arm Description

Patients in this arm were not treated with HBO prior to CABG

Patients in this arm were treated with HBO prior to CABG

Outcomes

Primary Outcome Measures

Myocardial Hsp72 protein
Myocardial eNOS protein
Serum Troponin-T
Serum soluble ICAM-1
Serum soluble PSGL-1
Serum soluble P-Selectin
Serum soluble E-Selectin

Secondary Outcome Measures

All cardiovascular haemodynamic parameters as measured by a pulmonary artery catheter
Duration of mechanical ventilation
Duration of endotracheal intubation
Length of stay in ICU
Blood loss
Inotrope usage
Atrial Fibrillation
Low cardiac output status
Pulmonary complications
Renal Complications
Cerebrovascular complications
Gastrointestinal complications
Wound complications
Cost of ICU stay

Full Information

First Posted
February 14, 2008
Last Updated
July 11, 2019
Sponsor
Hull University Teaching Hospitals NHS Trust
Collaborators
North of England Medical & Hyperbaric Services
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1. Study Identification

Unique Protocol Identification Number
NCT00623142
Brief Title
The Protective Effects Of Treatment With Hyperbaric Oxygen Prior To Bypass Heart Surgery
Official Title
The Effects of Hyperbaric Oxygen Preconditioning On Cardiovascular Protection & Ischemic Reperfusion Injury
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hull University Teaching Hospitals NHS Trust
Collaborators
North of England Medical & Hyperbaric Services

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Reperfusion Injury, Cytoprotection
Keywords
Myocardial protection, Ischemic Reperfusion Injury, Hyperbaric Oxygen, Preconditioning

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
No Intervention
Arm Description
Patients in this arm were not treated with HBO prior to CABG
Arm Title
B
Arm Type
Experimental
Arm Description
Patients in this arm were treated with HBO prior to CABG
Intervention Type
Drug
Intervention Name(s)
Hyperbaric Oxygen
Other Intervention Name(s)
Hyperbaric Oxygen Preconditioning
Intervention Description
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
Primary Outcome Measure Information:
Title
Myocardial Hsp72 protein
Time Frame
Intra-operative (During CABG)
Title
Myocardial eNOS protein
Time Frame
Intra-Operative (During CABG)
Title
Serum Troponin-T
Time Frame
Peri-operative
Title
Serum soluble ICAM-1
Time Frame
Peri-operative
Title
Serum soluble PSGL-1
Time Frame
Peri-operative
Title
Serum soluble P-Selectin
Time Frame
Peri-operative
Title
Serum soluble E-Selectin
Time Frame
Peri-operative
Secondary Outcome Measure Information:
Title
All cardiovascular haemodynamic parameters as measured by a pulmonary artery catheter
Time Frame
Peri-operative
Title
Duration of mechanical ventilation
Time Frame
Post Operative
Title
Duration of endotracheal intubation
Time Frame
post operative
Title
Length of stay in ICU
Time Frame
Post-operative
Title
Blood loss
Time Frame
Post operative
Title
Inotrope usage
Time Frame
Post operative
Title
Atrial Fibrillation
Time Frame
Post operative
Title
Low cardiac output status
Time Frame
Post operative
Title
Pulmonary complications
Time Frame
Post operative
Title
Renal Complications
Time Frame
Post operative
Title
Cerebrovascular complications
Time Frame
Post operative
Title
Gastrointestinal complications
Time Frame
Post operative
Title
Wound complications
Time Frame
Post operative
Title
Cost of ICU stay
Time Frame
Post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeysen Z Yogaratnam, MB.BCh, BAO, MRCS
Organizational Affiliation
Hull & East Yorkshire NHS Trust (Castle Hill Hospital), United Kingdom
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hull & East Yorkshire NHS Trust (Castle Hill Hospital)
City
Hull
State/Province
East Riding Of Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
17996900
Citation
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.
Results Reference
background
PubMed Identifier
17526467
Citation
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. doi: 10.1007/BF02849998.
Results Reference
background
PubMed Identifier
16945821
Citation
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. doi: 10.1016/j.carrev.2006.04.006.
Results Reference
background
PubMed Identifier
21721351
Citation
Jeysen 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.
Results Reference
background
PubMed Identifier
20129356
Citation
Yogaratnam 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.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=The+Effects+of+Hyperbaric+Oxygen+Preconditioning+On+Cardiovascular+Protection+%26+Ischemic+Reperfusion+Injury
Description
publication link - Abstract

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

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