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

Cardiac Surgery Patients Clinical Trial

Official title:

The Neuroprotection of Remote Ischemic Preconditioning on Cardiac Surgery in Multicenter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01231789
• Other study ID #: RIPC-Cardiac-Neuroprotection
• Status: Recruiting
• Phase: N/A
• First received: September 15, 2010
• Last updated: August 19, 2012
• Start date: June 2009
• Est. completion date: August 2013

Study information

• Verified date: June 2009
• Source: Xijing Hospital
• Contact: Hailong DONG, MD, PhD
• Phone: 86-2984775337
• Email: hldong6[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: National Natural Science FoundationChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiac Surgery Patients

Intervention

Procedure:
• RIPC
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
• sham RIPC
Patients had a deflated cuff placed on the right upper arm for 30 min without any inflation procedure.

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	mini-mental state examination scale	the neurological function	6 months after surgery	No