Intermittent Normoxia Reduces Myocardial Reperfusion Injury (INCPB)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Central South University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Central South University
ClinicalTrials.gov Identifier:
NCT01348906
First received: May 3, 2011
Last updated: May 5, 2011
Last verified: May 2011
  Purpose

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 Intervention
Hyperoxia
Procedure: intermittent normoxia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Intermittent Normoxic Cardiopulmonary Bypass on Myocardial Reperfusion Injury in Adult Valve Replacement

Further study details as provided by Central South University:

Primary Outcome Measures:
  • plasma concentration of troponin I [ Time Frame: within the first 24h after cardiac surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • gene expression of TNFa, IL-6, and IL-10 in myocardium [ Time Frame: 30 min after aotic de-clamping ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: May 2011
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348906

Contacts
Contact: Shengxi Chen, M.D. 86-731-89753413 shengxi.chen@hotmail.com
Contact: Li Li, M.D. 86-731-84327097 lovelily0920@yahoo.cn

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

No publications provided

Responsible Party: Shengxi Chen, Department of Cardiothoracic Surgery, Xiangya Hospital, Central South University, China
ClinicalTrials.gov Identifier: NCT01348906     History of Changes
Other Study ID Numbers: INCPB
Study First Received: May 3, 2011
Last Updated: May 5, 2011
Health Authority: China: Ministry of Health

Keywords provided by Central South University:
cardiopulmonary bypass

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

ClinicalTrials.gov processed this record on April 17, 2014