The Neuroprotection of Remote Ischemic Preconditioning (RIPC) on Cardiac Surgery in Multicenter

Study Overview
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Brief Summary
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The current study is designed to clarify the neuroprotective effect of remote ischemic preconditioning on the patients underwent open-heart cardiac surgery.

Detailed Description
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BACKGROUND: Brain ischemia and injury are commonly contributed to perioperative morbidity and mortality after cardiac surgery. Remote ischemic preconditioning (RIPC) is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ provide systemic protection from prolonged ischemia. To investigate whether remote preconditioning protects the brain injury in patients undergoing elective cardiac surgery, a randomized trial will be performed in current study. DESIGNING 150 patients will be randomize assigned to cardiac surgery with RIPC or without RIPC (control). Remote ischemic preconditioning consist of three 5-min cycles of right upper limb ischaemia, induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff is deflated. Cerebral injury was assessed by S-100b, NSE, and neurological function scores in different time points. EXPECTED RESULTS RIPC will reduce the incidence of cerebral injury in cardiac surgery. CONCLUSIONS: In patients undergoing elective cardiac surgery, RIPC reduces the incidence of postoperative cerebral injury.

Official Title
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The Neuroprotection of Remote Ischemic Preconditioning on Cardiac Surgery in Multicenter

Conditions
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Cardiac Surgery Patients

Intervention / Treatment
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* Procedure: RIPC
* Procedure: sham RIPC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with acquired heart valve diseases scheduled for valve replacement or CABG Exclusion Criteria: Were unable to give informed consent Patients who presented with other systemic diseases such as hepatic,renal, and pulmonary diseases, or have had a heart operation before, were excluded. Additionally, patients taking antidiabetic sulfonylurea or glibenclamide were excluded because these agents have been shown to abrogate the cardioprotection elicited by ischemic preconditioning.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: sham RIPC<br>Patients had a deflated cuff placed on the right upper arm for 30 min. | Procedure: sham RIPC<br>* Patients had a deflated cuff placed on the right upper arm for 30 min without any inflation procedure.<br>* Other names: sham remote ischemic preconditioning;|
| Experimental: RIPC treatment<br>RIPC consisted of three 5-min cycles of right upper arm ischemia, which was induced by an automated cuff-inflator placed on the right upper arm and inflated to 200 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated | Procedure: RIPC<br>* RIPC consisted of three 5-min cycles of right upper arm ischemia, which was induced by an automated cuff-inflator placed on the right upper arm and inflated to 200 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated<br>* Other names: remote ischemic preconditioning;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the neurological injury markers, including serum level of S-100B and NSE | the biomarkers of brain injury | before surgery, 6h, 24h, 48h, and 72h after bypass | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mini-mental state examination scale | the neurological function | 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, RIPC, brain injury