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Myocardial Reperfusion InjuryPhase 1/2NCT00623142

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

A Phase 1/2 study testing Hyperbaric Oxygen in people with Myocardial Reperfusion Injury and Cytoprotection, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
Myocardial Reperfusion Injury, Cytoprotection
What is being tested?
Hyperbaric Oxygen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteUnited Kingdom
Study dates
Jan 2005to Jan 2008
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients undergoing elective first time CABG
  • Patients with at least 1 vessel coronary artery disease undergoing on- pump CABG

Who cannot join

  • 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)
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

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

    Hull, East Riding Of Yorkshire, HU16 5JQ

Other trials in United Kingdom

About this study

Official title: 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.

Being tested
Hyperbaric Oxygen
Keywords
Myocardial protection, Ischemic Reperfusion Injury, Hyperbaric Oxygen, Preconditioning
Medical subject headings
Myocardial Reperfusion Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyperbaric OxygenDrug

    Also called Hyperbaric Oxygen Preconditioning

    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

Study groups in NCT00623142
Study groupRoleWhat they receive
ANo interventionPatients in this arm were not treated with HBO prior to CABG
BExperimentalPatients in this arm were treated with HBO prior to CABG
Receives: Drug: Hyperbaric Oxygen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Myocardial Hsp72 protein

    Measured: Intra-operative (During CABG)

  2. Myocardial eNOS protein

    Measured: Intra-Operative (During CABG)

  3. Serum Troponin-T

    Measured: Peri-operative

  4. Serum soluble ICAM-1

    Measured: Peri-operative

  5. Serum soluble PSGL-1

    Measured: Peri-operative

  6. Serum soluble P-Selectin

    Measured: Peri-operative

  7. Serum soluble E-Selectin

    Measured: Peri-operative

Secondary outcomes (14)

  1. All cardiovascular haemodynamic parameters as measured by a pulmonary artery catheter

    Measured: Peri-operative

  2. Duration of mechanical ventilation

    Measured: Post Operative

  3. Duration of endotracheal intubation

    Measured: post operative

  4. Length of stay in ICU

    Measured: Post-operative

  5. Blood loss

    Measured: Post operative

  6. Inotrope usage

    Measured: Post operative

  7. Atrial Fibrillation

    Measured: Post operative

  8. Low cardiac output status

    Measured: Post operative

  9. Pulmonary complications

    Measured: Post operative

  10. Renal Complications

    Measured: Post operative

  11. Cerebrovascular complications

    Measured: Post operative

  12. Gastrointestinal complications

    Measured: Post operative

  13. Wound complications

    Measured: Post operative

  14. Cost of ICU stay

    Measured: Post operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2008 (estimated)
  2. Study startJan 2005
  3. Primary completionJan 2007
  4. Study completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00623142
Sponsor's protocol ID
R0047
Other IDs
04/Q1104/26
Status last verified
Jul 2019
First submitted
14 Feb 2008
Last updated
15 Jul 2019
Results posted
No
Data monitoring committee
Yes

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. 2008 Sep;149(1):155-64. doi: 10.1016/j.jss.2007.09.003. Epub 2007 Oct 11.

    PubMed 17996900

  • 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.

    PubMed 17526467

  • 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.

    PubMed 16945821

  • 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.

    PubMed 21721351

  • 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.

    PubMed 20129356

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Hyperbaric Oxygen in people with Myocardial Reperfusion Injury and Cytoprotection, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial Hsp72 protein (time frame: Intra-operative (During CABG)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00623142, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.

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