Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery

Atrial Fibrillation Clinical Trial

Official title:

Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00882622
• Other study ID #: A165/08_2
• Status: Withdrawn
• Phase: Phase 1
• First received: April 14, 2009
• Last updated: January 17, 2012
• Start date: February 2009
• Est. completion date: February 2009

Study information

• Verified date: January 2012
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on cardiac function in patients undergoing cardiac surgery compared to control intervention.

Description:

In detail, we will focus on new onset of atrial fibrillation, ventricular arrhythmias, myocardial injury, and cardiac function. Furthermore, we aim to investigate underlying pathways of RIPC in modifying the perioperative stress response.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient undergoing heart surgery on cardiopulmonary bypass

Exclusion Criteria:

• Emergency cases

• Myocardial infarction up to 7 days prior to enrollment

• Ejection fraction less than 30%

• Inability to give informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiac Function
• Myocardial Injury
• Ventricular Arrythmias

Intervention

Procedure:
• Remote Ischemic Preconditioning
RIPC will be induced during anesthesia by four 5-min cycles of upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 15 mm Hg greater than the systolic arterial pressure measured via the arterial line.
• Control/sham procedure
Sham placement of the blood pressure cuff around the upper limb without inflation.

Locations

Country	Name	City	State
Germany	University Hospital	Frankfurt am Main
Germany	University Hospital Schleswig-Holstein	Kiel

Sponsors (2)

Lead Sponsor	Collaborator
Patrick Meybohm	University Hospital, Frankfurt

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New onset of atrial fibrillation		Within 30 days after surgery	No
Secondary	Ventricular arrhythmias, myocardial injury, cardiac function. Underlying pathways of Remote Ischemic Preconditioning in modifying the perioperative stress response.		Within 24 hours after surgery	No