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

NCT ID: NCT01231789

Last Updated: 2012-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-08-31

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.

Conditions

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Cardiac Surgery Patients

Keywords

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cardiac surgery RIPC brain injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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sham RIPC

Patients had a deflated cuff placed on the right upper arm for 30 min.

Group Type SHAM_COMPARATOR

sham RIPC

Intervention Type PROCEDURE

Patients had a deflated cuff placed on the right upper arm for 30 min without any inflation procedure.

RIPC treatment

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

Group Type EXPERIMENTAL

RIPC

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

sham RIPC

Patients had a deflated cuff placed on the right upper arm for 30 min without any inflation procedure.

Intervention Type PROCEDURE

Other Intervention Names

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remote ischemic preconditioning sham remote ischemic preconditioning

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hailong Dong, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Locations

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Xijing Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hailong DONG, MD, PhD

Role: CONTACT

Phone: 86-2984775337

Email: [email protected]

Facility Contacts

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Hailong Dong, MD,PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36148077 (View on PubMed)

Other Identifiers

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RIPC-Cardiac-Neuroprotection

Identifier Type: -

Identifier Source: org_study_id