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

This study is currently recruiting participants.
Verified June 2009 by Xijing Hospital
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01231789
First received: September 15, 2010
Last updated: August 19, 2012
Last verified: June 2009

September 15, 2010
August 19, 2012
June 2009
June 2013   (final data collection date for primary outcome measure)
the neurological injury markers, including serum level of S-100B and NSE [ Time Frame: before surgery, 6h, 24h, 48h, and 72h after bypass ] [ Designated as safety issue: No ]
the biomarkers of brain injury
Same as current
Complete list of historical versions of study NCT01231789 on ClinicalTrials.gov Archive Site
mini-mental state examination scale [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
the neurological function
Same as current
Not Provided
Not Provided
 
The Neuroprotection of Remote Ischemic Preconditioning (RIPC) on Cardiac Surgery in Multicenter
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Cardiac Surgery Patients
  • 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
  • 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
  • Sham Comparator: sham RIPC
    Patients had a deflated cuff placed on the right upper arm for 30 min.
    Intervention: Procedure: sham RIPC
  • 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
    Intervention: Procedure: RIPC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
August 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact: Hailong DONG, MD, PhD 86-2984775337 hldong6@hotmail.com
China
 
NCT01231789
RIPC-Cardiac-Neuroprotection
No
Xijing Hospital
Xijing Hospital
Not Provided
Principal Investigator: Hailong Dong, MD,PhD Xijing Hospital
Xijing Hospital
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP