Clinical Value of Remote Ischemic Preconditioning

This study has been completed.
Sponsor:
Collaborators:
Levanger Hospital
Namsos Hospital
Sykehuset Innlandet HF
Helse Møre og Romsdal HF
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01740102
First received: November 21, 2012
Last updated: October 30, 2013
Last verified: October 2013

November 21, 2012
October 30, 2013
August 2012
January 2013   (final data collection date for primary outcome measure)
Postoperative atrial fibrillation [ Time Frame: Up to 10 days after surgery ] [ Designated as safety issue: No ]
A patient will be classified as belonging to the postoperative atrial fibrillation group if they have any episode of atrial fibrillation, measured by telemetry, lasting more than 1 minute during their postoperative days at the hospital.
Same as current
Complete list of historical versions of study NCT01740102 on ClinicalTrials.gov Archive Site
Length of hospital stay [ Time Frame: Maximum 14 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical Value of Remote Ischemic Preconditioning
Does Remote Ischemic Preconditioning Reduce the Incidence of Postoperative Atrial Fibrillation in Patient Undergoing Coronary Artery Bypass Graft Surgery?

Objectives: Despite utilization of available means for cardioprotection during cardiac surgery, myocardial injury still occurs. Further improvement of cardioprotection is therefore necessary. Remote ischemic preconditioning (RIPC) is an easy and non-invasive method. Laboratory research has shown promising results regarding myocardial survival during open heart surgery, but the clinical value of RIPC is still largely unknown. The investigators hypothesize that RIPC before coronary artery bypass grafting (CABG) reduces the incidence of postoperative atrial fibrillation (POAF).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Heart Diseases
  • Atrial Fibrillation
Procedure: RIPC
The remote ischemic preconditioning will consist of three sequential sphygmomanometer cuff inflations. The cuff will be inflated up to 200 mmHg for 5 minutes and then deflated for 5 minutes. This cycle will be performed three times in total. The entire preconditioning will therefore last for 25 minutes.
Other Names:
  • Remote ischemic preconditioning
  • Ischemic preconditioning
  • Experimental: RIPC
    Remote ischemic preconditioning (RIPC) in the operating theatre after induction of anaesthesia and before surgery.
    Intervention: Procedure: RIPC
  • No Intervention: No RIPC
    Patients in the control group will not receive remote ischemic preconditioning before the surgery.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
September 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Elective isolated on-pump CABG surgery
  • Informed consent

Exclusion Criteria:

  • Patients with a severe pulmonary disease
  • Patients with renal failure (GFR<30 mL/min/1.73 m2)
  • Patients with liver failure
  • Peripheral vascular disease affecting the upper limbs
  • Patients on sulfonylurea derivatives.
  • Patients with atrial fibrillation in their case history
  • Prior cardiac surgery (Re-operations)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01740102
2011/2525
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
  • Levanger Hospital
  • Namsos Hospital
  • Sykehuset Innlandet HF
  • Helse Møre og Romsdal HF
Study Director: Alexander Wahba, MD prof Faculty of Medicine Norwegian University of Science and Technology Trondheim, Norway, and Department of Cardiothoracic Surgery, St. Olavs Hospital, Trondheim, Norway.
Principal Investigator: Lars Erik B Krogstad Faculty of Medicine Norwegian University of Science and Technology Trondheim, Norway.
Norwegian University of Science and Technology
October 2013

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