Clinical trial NCT01231789: The Neuroprotection of Remote Ischemic Preconditioning (RIPC) on Cardiac Surgery in Multicenter
Official title: The Neuroprotection of Remote Ischemic Preconditioning on Cardiac Surgery in Multicenter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Surgery Patients
Keywords: cardiac surgery
RIPC
brain injury
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2010-11-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: the neurological injury markers, including serum level of S-100B and NSE
timeFrame: before surgery, 6h, 24h, 48h, and 72h after bypass
Secondary outcomes:
measure: mini-mental state examination scale
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Hailong Dong, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhu S, Zheng Z, Lv W, Ouyang P, Han J, Zhang J, Dong H, Lei C. Neuroprotective effect of remote ischemic preconditioning in patients undergoing cardiac surgery: A randomized controlled trial. Front Cardiovasc Med. 2022 Sep 6;9:952033. doi: 10.3389/fcvm.2022.952033. eCollection 2022.