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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Xijing Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01231789
First Posted: November 1, 2010
Last Update Posted: August 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Xijing Hospital
  Purpose
The current study is designed to clarify the neuroprotective effect of remote ischemic preconditioning on the patients underwent open-heart cardiac surgery.

Condition Intervention
Cardiac Surgery Patients Procedure: RIPC Procedure: sham RIPC

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Neuroprotection of Remote Ischemic Preconditioning on Cardiac Surgery in Multicenter

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • mini-mental state examination scale [ Time Frame: 6 months after surgery ]
    the neurological function


Estimated Enrollment: 150
Study Start Date: June 2009
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: remote ischemic preconditioning

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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231789


Contacts
Contact: Hailong DONG, MD, PhD 86-2984775337 hldong6@hotmail.com

Locations
China, Shaanxi
Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Hailong Dong, MD,PhD         
Principal Investigator: Hailong Dong, MD,PhD         
Sponsors and Collaborators
Xijing Hospital
Investigators
Principal Investigator: Hailong Dong, MD,PhD Xijing Hospital
  More Information

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01231789     History of Changes
Other Study ID Numbers: RIPC-Cardiac-Neuroprotection
First Submitted: September 15, 2010
First Posted: November 1, 2010
Last Update Posted: August 21, 2012
Last Verified: June 2009

Keywords provided by Xijing Hospital:
cardiac surgery
RIPC
brain injury