Cardiac Surgery Patients
Conditions
Keywords
cardiac surgery, RIPC, brain injury
Brief summary
The current study is designed to clarify the neuroprotective effect of remote ischemic preconditioning on the patients underwent open-heart cardiac surgery.
Detailed description
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.
Interventions
PROCEDURERIPC
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
PROCEDUREsham RIPC
Patients had a deflated cuff placed on the right upper arm for 30 min without any inflation procedure.
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the neurological injury markers, including serum level of S-100B and NSE | before surgery, 6h, 24h, 48h, and 72h after bypass | the biomarkers of brain injury |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mini-mental state examination scale | 6 months after surgery | the neurological function |
Countries
China
Contacts
Primary ContactHailong DONG, MD, PhD
Outcome results
None listed