Remote Ischemic Preconditioning on Pulmonary Injury in Cardic Surgery

Study Overview
=================
Brief Summary
-----------------
During cardiac surgery with cardiopulmonary bypass , pulmonary dysfunction remains to be a problem complicating the postoperative course of the patients.Remote ischemic preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive strategy.Recent several trials suggested that RIPC could provide pulmonary protection by reducing serum biomarkers,however,whether the RIPC can improve the clinical outcomes in patients undergoing on-pump cardiac surgery,is still uncertain. The study hypothesis is: remote ischemic preconditioning will provide lung-protective effect and improve clinical outcomes in patients undergoing cardic surgery.

Detailed Description
-----------------
Remote ischemic preconditioning (RIPC) protocol will be induced during anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood pressure cuff inflated to a pressure 200mmHg

Official Title
-----------------
Effect of Remote Ischemic Preconditioning on Pulmonary Injury in Cardic Surgery

Conditions
-----------------
Lung Injury, Remote Ischemic Preconditioning

Intervention / Treatment
-----------------
* Procedure: Remote Ischemic Preconditioning
* Procedure: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing heart surgery on cardiopulmonary bypass Patients aged 18 years to 80 years Exclusion Criteria: Inability to give informed consent Preoperative severe impairment of respiratory function (arterial oxygen tension (PaO2) <60 mmHg or FEV1<50% predicted) Prior receipt of chemotherapy or radiation therapy or immunotherapy left ventricular ejection fraction less than 30% preoperative use of inotropics or mechanical assist device Patients with significant hepatic dysfunction (Prothrombin>2.0 ratio) Patients with known renal failure with a GFR<30 mL/min/1.73 m2 recent myocardial infarction (within 7 days) Systemic or local active infections (either clinically defined or suggested by evidence such as elevated C-reactive protein levels, leukocytosis, or a body temperature>38℃) Significant peripheral arterial disease affecting the upper limbs surgeries: cardiac transplantation, concomitant carotid endarterectomy , previous heart surgery,, off-pump surgery, emergency surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remote Ischemic Preconditioning(RIPC)<br>3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200mmHg will be given to RIPC | Procedure: Remote Ischemic Preconditioning<br>* RIPC will be induced during anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200mmHg<br>* Other names: RIPC;|
| Placebo Comparator: Control<br>Control group without remote ischemic preconditioning | Procedure: Control<br>* Control group witnout remote ischemic preconditioning<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of PaO2/FiO2 over 24 hours after cardiac surgery |  | 24 hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 30 days post surgery | 
| Postoperative Pulmonary Complications |  | 30 days post surgery |