Intermittent Normoxia Reduces Myocardial Reperfusion Injury (INCPB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01348906
Recruitment Status : Unknown
Verified May 2011 by Central South University.
Recruitment status was:  Recruiting
First Posted : May 6, 2011
Last Update Posted : May 6, 2011
Information provided by:
Central South University

Brief Summary:
This study aims to determine the effect of intermittent normoxic cardiopulmonary bypass (CPB) on inflammatory response, oxidative stress and myocardial reperfusion injury in adult patients undergoing valve replacement. The investigators hypothesized that nuclear factor kappa B (NFkB) was involved in regulating gene expression of myocardial inflammatory factor.

Condition or disease Intervention/treatment Phase
Hyperoxia Procedure: intermittent normoxia Not Applicable

Detailed Description:

Methods:Patients meeting the requirement will be randomized into 2 groups: the control group received hyperoxic reperfusion (PaO2 180-250 mmHg) throughout CPB as routine; the treatment group underwent 3 cycles of 5/5 min normal/high oxygenation (PaO2 80-150/180-250 mmHg) during cardioplegia arrest, and maintained the same hyperoxia as the control group in the rest time of CPB. The clinical data of inotropes requirement, drainage, ventilation and intensive care time will be recorded. Venous blood samples will be taken perioperatively for detecting concentration of troponin I (cTnI), tumor necrosis factor-α , interleukin-6, 10, and malondialdehyde (MDA). Atrial biopsies will be removed before cardioplegia arrest and 30min after aortic de-clamping to determine the extent of neutrophil infiltration (myeloperoxidase activity), NFkB binding DNA activity, and gene expression of inflammatory factors (TNF-α, IL-6, 10).

Statistical analysis:A sample size of at least 32 patients in each group was needed to have a power of 90%, significance at the two-side 5% level, on the basis that a SD of 0.2 ng/ml and a difference in peak serum cTnI release of about 0.15 ng/ml between control and conditioned patients was determined.

Expected Results: The treatment group will have significantly lower release of cTnI, inflammatory factors, and MDA during CPB and afterwards. Intermittent normoxia may be related to less myocardial inflammation characterized by decreased myeloperoxidase activity, gene expression of inflammatory factors, the later may result from reduced activity of NFkB binding to DNA after reperfusion.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Intermittent Normoxic Cardiopulmonary Bypass on Myocardial Reperfusion Injury in Adult Valve Replacement
Study Start Date : May 2011
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : July 2011

Arm Intervention/treatment
Experimental: Intermittent normoxia
Repeated brief normoxic reperfusion during cardioplegia arrest in adult valve replacement
Procedure: intermittent normoxia
3 cycles of 5/5 min normoxia/hyperoxic reperfusion during cardioplegia arrest in adult valve replacement

Primary Outcome Measures :
  1. plasma concentration of troponin I [ Time Frame: within the first 24h after cardiac surgery ]

Secondary Outcome Measures :
  1. gene expression of TNFa, IL-6, and IL-10 in myocardium [ Time Frame: 30 min after aotic de-clamping ]

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • rheumatic heart valve disease requiring selective aortic or double valve(aortic and mitral valve) replacement

Exclusion Criteria:

  • infective endocarditis congenital valve disease previous cardiac surgery complicated with diabetes, coronary artery disease, hypertension or peripheral vascular disease.

receiving aspirin, corticosteroids, angiotensin-converting enzyme inhibitors or statin perioperatively

Information from the National Library of Medicine

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 identifier (NCT number): NCT01348906

Contact: Shengxi Chen, M.D. 86-731-89753413
Contact: Li Li, M.D. 86-731-84327097

China, Hunan
Department of Cardiothoracic Surgery, Xiangya Hospital, Central South University Recruiting
Changsha City, Hunan, China, 410008
Contact: Wanjun , Luo    86-731-89753703   
Sub-Investigator: Li Li, M.D.         
Sponsors and Collaborators
Central South University

Responsible Party: Shengxi Chen, Department of Cardiothoracic Surgery, Xiangya Hospital, Central South University, China Identifier: NCT01348906     History of Changes
Other Study ID Numbers: INCPB
First Posted: May 6, 2011    Key Record Dates
Last Update Posted: May 6, 2011
Last Verified: May 2011

Keywords provided by Central South University:
cardiopulmonary bypass

Additional relevant MeSH terms:
Reperfusion Injury
Myocardial Reperfusion Injury
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Myocardial Ischemia