Effect of Remote Ischemic Preconditioning on Cardiac Function After Cardiac Surgery

NCT00882622 — Phase 1, Withdrawn, Patrick Meybohm

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Registry	NCT00882622
Status	Withdrawn - Endpoints were investigated in parallel in NCT00877305
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: triple, treatment
Sponsor	Patrick Meybohm (Other); collaborators: Goethe University
Conditions	Atrial Fibrillation, Ventricular Arrythmias, Myocardial Injury, Cardiac Function
Interventions	Remote Ischemic Preconditioning, Control/sham procedure (Procedure)
Dates	start 2009-02-01, primary completion 2009-02-01, completion 2009-02-01, first posted 2009-04-16, last updated 2012-01-18
Locations	2 sites in Germany

-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.

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+Detailed 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.

+Arms and interventions

Arm	Type	Interventions	Description
RIPC	Active comparator	Procedure: Remote Ischemic Preconditioning
CONTROL	Sham comparator	Procedure: Control/sham procedure

Remote Ischemic Preconditioning (Procedure): 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 (Procedure): Sham placement of the blood pressure cuff around the upper limb without inflation.

+Outcome measures

Primary outcomes

New onset of atrial fibrillation [Within 30 days after surgery]

Secondary outcomes

Ventricular arrhythmias, myocardial injury, cardiac function. Underlying pathways of Remote Ischemic Preconditioning in modifying the perioperative stress response. [Within 24 hours after surgery]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (2)

Facility	City	Country	Status
University Hospital	Frankfurt am Main	Germany
University Hospital Schleswig-Holstein	Kiel	Germany