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Clinical Trials/NCT01231789
NCT01231789
Unknown
Not Applicable

The Neuroprotection of Remote Ischemic Preconditioning on Cardiac Surgery in Multicenter

Xijing Hospital1 site in 1 country150 target enrollmentJune 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Surgery Patients
Sponsor
Xijing Hospital
Enrollment
150
Locations
1
Primary Endpoint
the neurological injury markers, including serum level of S-100B and NSE
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
August 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Xijing Hospital
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

the neurological injury markers, including serum level of S-100B and NSE

Time Frame: before surgery, 6h, 24h, 48h, and 72h after bypass

the biomarkers of brain injury

Secondary Outcomes

  • mini-mental state examination scale(6 months after surgery)

Study Sites (1)

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