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

Primary Purpose

Acute Lung Injury

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
remote ischemic preconditioning and postconditioning
Control
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Lung Injury focused on measuring RIPC, lung protection, ischemic reperfusion injury, cardiopulmonary bypass

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RIPC

Control

Arm Description

those who receive RIPC and RIPoC before and after CPB

this group have same pneumatic cuff around their arm, but it is not inflated.

Outcomes

Primary Outcome Measures

arterial partial pressure of oxygen divided by fraction of inspired oxygen
follow up PaO2/FiO2 during operation and after the opreation for 24 hours

Secondary Outcome Measures

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

Full Information

First Posted
June 9, 2010
Last Updated
June 3, 2014
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01144585
Brief Title
Effects of Remote Ischemic Preconditioning and Postconditioning on Lung Injury During Cardiopulmonary Bypass
Official Title
Effects of Remote Ischemic Preconditioning and Postconditioning on Lung Ischemic-reperfusion Injury During Cardiopulmonary Bypass - Substudy of NCT00997217
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury
Keywords
RIPC, lung protection, ischemic reperfusion injury, cardiopulmonary bypass

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RIPC
Arm Type
Experimental
Arm Description
those who receive RIPC and RIPoC before and after CPB
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
this group have same pneumatic cuff around their arm, but it is not inflated.
Intervention Type
Procedure
Intervention Name(s)
remote ischemic preconditioning and postconditioning
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
This group has same pneumatic cuff during the surgery, but it is not inflated during the surgery
Primary Outcome Measure Information:
Title
arterial partial pressure of oxygen divided by fraction of inspired oxygen
Description
follow up PaO2/FiO2 during operation and after the opreation for 24 hours
Time Frame
within 24hr after the surgery
Secondary Outcome Measure Information:
Title
plasma cytokines
Description
follow up plasma IL-6, IL-8, IL-10, TNF-alpha levels during the surgery and within 24hr after the surgery
Time Frame
within 24hr after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YunSeok Jeon, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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