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

August 19, 2012 updated by: Xijing Hospital

The Neuroprotection of Remote Ischemic Preconditioning on Cardiac Surgery in Multicenter

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital
        • Principal Investigator:
          • Hailong Dong, MD,PhD
        • Contact:
          • Hailong Dong, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: sham RIPC
Patients had a deflated cuff placed on the right upper arm for 30 min.
Procedure: sham RIPC
Patients had a deflated cuff placed on the right upper arm for 30 min without any inflation procedure.
Other Names:
  • sham remote ischemic preconditioning
Experimental: 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
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
Other Names:
  • remote ischemic preconditioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
before surgery, 6h, 24h, 48h, and 72h after bypass

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mini-mental state examination scale
Time Frame: 6 months after surgery
the neurological function
6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

September 15, 2010

First Submitted That Met QC Criteria

October 29, 2010

First Posted (Estimate)

November 1, 2010

Study Record Updates

Last Update Posted (Estimate)

August 21, 2012

Last Update Submitted That Met QC Criteria

August 19, 2012

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RIPC-Cardiac-Neuroprotection

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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