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

Effects of Remote Ischemic Preconditioning and Postconditioning on Lung Ischemic-reperfusion Injury During Cardiopulmonary Bypass - Substudy of NCT00997217

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.

Study Overview

• Status: Completed
• Conditions: Acute Lung Injury
• Intervention / Treatment: Procedure: remote ischemic preconditioning and postconditioning; Procedure: Control

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.

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RIPC; those who receive RIPC and RIPoC before and after CPB	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.
Placebo Comparator: Control; this group have same pneumatic cuff around their arm, but it is not inflated.	Procedure: Control; This group has same pneumatic cuff during the surgery, but it is not inflated during the surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: June 9, 2010
• First Submitted That Met QC Criteria: June 14, 2010
• First Posted (Estimate): June 15, 2010

Study Record Updates

• Last Update Posted (Estimate): June 4, 2014
• Last Update Submitted That Met QC Criteria: June 3, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: cardiopulmonary bypass; RIPC; lung protection; ischemic reperfusion injury
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Postoperative Complications; Thoracic Injuries; Wounds and Injuries; Reperfusion Injury; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: H-1001-016-306