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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00882622
Other study ID # A165/08_2
Secondary ID
Status Withdrawn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Status Withdrawn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


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
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