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NCT Number: NCT01144585

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

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

remote ischemic preconditioning and postconditioning

Procedure

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.

Control

Procedure

This group has same pneumatic cuff during the surgery, but it is not inflated during the surgery

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 15, 2010
Registry last updated
Jun 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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