Effects of Remote Ischemic Preconditioning and Postconditioning on Lung Injury During Cardiopulmonary Bypass

Overview

Remote Ischemic Preconditioning(RIPC) and remote ischemic postconditioning(RIPoC) seems to have a protective effect during ischemic period. Using cardiopulmonary bypass(CPB) during open heart surgery reduces pulmonary blood flow and may cause ischemic damage to lung tissue. The investigators anticipate that RIPC and RIPoC may reduce lung injury after CPB.

Full Title of Study: “Effects of Remote Ischemic Preconditioning and Postconditioning on Lung Ischemic-reperfusion Injury During Cardiopulmonary Bypass – Substudy of NCT00997217”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: November 2010

Detailed Description

Cardiopulmonary bypass(CPB) can cause lung function deterioration through various mechanisms. Lung parenchymal tissue ischemia resulted by pulmonary atelectasis and decreased bronchial circulation during CPB is one of the reasons. There were few studies reported that RIPC and RIPoCcan benefit lung function of children or infant after CPB, but studies about adults are still lacking. Purpose: The purpose of this study is to evaluate effect of RIPC and RIPoC on the lung function after CPB. Methods: Patients will randomly allocated either in study group or control group. Study group will receive RIPC and RIPoC maneuver before and after CPB. Control group will have same automated cuff around their arm but it will not activated. Care givers will be blinded whether the automated cuff is on or not. We will compare pulmonary parameters (PaO2/FiO2, dynamic and static compliances, Intrapulmonary shunts, etc.) between study group and control group, and check levels of plasma cytokines(IL-4, IL-8, IL-10, TNF-alpha) till 24hr after the operation.

Interventions

  • Procedure: remote ischemic preconditioning and postconditioning
    • RIPC is done before the use of CPB. It consists of 4 cycles of 5 minutes inflation of pneumatic cuff to 200 mmHg and deflation for 5 minutes. RIPoC is exactly same procedure done “after” CPB.
  • Procedure: Control
    • This group has same pneumatic cuff during the surgery, but it is not inflated during the surgery

Arms, Groups and Cohorts

  • Experimental: RIPC
    • those who receive RIPC and RIPoC before and after CPB
  • Placebo Comparator: Control
    • this group have same pneumatic cuff around their arm, but it is not inflated.

Clinical Trial Outcome Measures

Primary Measures

  • arterial partial pressure of oxygen divided by fraction of inspired oxygen
    • Time Frame: within 24hr after the surgery
    • follow up PaO2/FiO2 during operation and after the opreation for 24 hours

Secondary Measures

  • plasma cytokines
    • Time Frame: within 24hr after the surgery
    • follow up plasma IL-6, IL-8, IL-10, TNF-alpha levels during the surgery and within 24hr after the surgery

Participating in This Clinical Trial

Inclusion Criteria

  • those who aged 18-80 years old and planned to undergo elective open heart surgery using cardiopulmonary bypass Exclusion Criteria:

  • emergent operation – preoperative use of inotropics or mechanical assist device, – left ventricular ejection fraction less than 30%, – severe liver, renal disease, – recent myocardial infarction (within 7 days), – recent systemic infection or sepsis (within 7 days) – peripheral vascular disease affecting upper limbs – amputation of the upper limbs – major combined operation such as aortic surgery or carotid endarterectomy – descending thoracic aortic surgery – rare surgeries; cardiac transplantation, correction of complicated congenital anomalies, pulmonary thromboembolectomy, etc – significantly decreased pulmonary function before the planned surgery (e.g. using ventilator, oxygen therapy, tachypnea, orthopnea, active lung lesion on chest X-ray, FEV1/FVC less than 50% of predicted level, PaO2 less than 80 mmHg) – intracardiac shunt – severe pulmonary artery hypertension – systemic or local steroid therapy

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Seoul National University Hospital, Seoul National University Hospital
  • Overall Official(s)
    • YunSeok Jeon, MD, Study Director, Seoul National University Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.