Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)
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The purpose of this study is to evaluate the effects of Remote Ischaemic Preconditioning on perioperative ischaemic injury in patients undergoing cardiac surgery compared to control intervention.
Condition | Intervention | Phase |
---|---|---|
Myocardial Injury Mortality |
Procedure: Remote Ischemic Preconditioning Procedure: Control/sham procedure (blood pressure cuff) |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
Official Title: | Remote Ischaemic Preconditioning for Heart Surgery |
- Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure [ Time Frame: In-hospital ] [ Designated as safety issue: No ]
- Occurence of any component of the composite outcome [ Time Frame: Postoperative hospital discharge, 3 months, 12 months ] [ Designated as safety issue: No ]
- length of stay on the intensive care unit [ Time Frame: Postoperative during hospital stay ] [ Designated as safety issue: No ]
- total hospital stay [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]
- new onset of atrial fibrillation [ Time Frame: In-hospital ] [ Designated as safety issue: No ]
- Delirium [ Time Frame: Postoperative 24, 48, 72, 96 hrs ] [ Designated as safety issue: No ]
Estimated Enrollment: | 2070 |
Study Start Date: | December 2010 |
Estimated Study Completion Date: | April 2014 |
Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active Comparator: RIPC |
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 200 mm Hg, whereas the pressure has to be at least 20 mm Hg greater than the systolic arterial pressure measured via the arterial line.
|
Sham Comparator: CONTROL |
Procedure: Control/sham procedure (blood pressure cuff)
Sham placement of the blood pressure cuff around a dummy arm inflated to a pressure of 200 mm Hg with four cycles of 5 min inflation and 5 min deflation.
|
Detailed Description:
Cardiac surgery with cardiopulmonary bypass is associated with a predictable incidence of myocardial, neurological and renal dysfunction. This significant morbidity and mortality is at least partly due to perioperative ischaemia. Remote ischaemic preconditioning (RIPC) is a novel, simple, non-invasive and inexpensive intervention by which ischaemia of non-vital tissue (skeletal muscles) protects remote organs (heart, brain and kidney) from a subsequent sustained episode of ischaemia. The investigators perform a multicenter randomized controlled study to evaluate that RIPC reduces teh severity of perioperative ischaemic injury in patients undergoing cardiac surgery, and results in about 1/3 risk reduction in the occurence of major adverse events.
![](https://webarchive.library.unt.edu/web/20121019014426im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients undergoing heart surgery on cardiopulmonary bypass
Exclusion Criteria:
- age < 18
- Emergency cases
- left ventricular ejection fraction less than 30%
- current atrial fibrillation
- Inability to give informed consent
- preoperative use of inotropics or mechanical assist device
- severe liver, renal and pulmonary disease
- recent myocardial infarction (within 7 days)
- recent systemic infection or sepsis (within 7 days)
- severe stroke (within 2 months)
- peripheral vascular disease affecting upper limbs
- previous serious psychiatric disorders (e.g. schizophrenia, dementia)
- concomitant carotid endarterectomy
- rare surgeries: cardiac transplantation, correction of complicated congenital anomalies, pulmonary thromboembolectomy, off-pump surgery, minimal-invasive operation without sternotomy
![](https://webarchive.library.unt.edu/web/20121019014426im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Contact: Patrick Meybohm, MD | meybohm@anaesthesie.uni-kiel.de |
Germany | |
University Hospital Aachen (RWTH) | Recruiting |
Aachen, Germany | |
Contact: Christian Stoppe | |
University Hospital Charite | Recruiting |
Berlin, Germany | |
Contact: Michael Sander | |
University Hospital Bonn | Recruiting |
Bonn, Germany | |
Contact: Pascal Knuefermann | |
University Hospital Frankfurt/M | Recruiting |
Frankfurt/M, Germany | |
Contact: Patrick Meybohm | |
Principal Investigator: Kai Zacharowski | |
University Hospital Goettingen | Recruiting |
Goettingen, Germany | |
Contact: Ivo Brandes | |
University Hospital Schleswig-Holstein | Recruiting |
Kiel, Germany | |
Contact: Berthold Bein | |
Principal Investigator: Patrick Meybohm | |
Sub-Investigator: Berthold Bein | |
Sub-Investigator: Jochen Cremer | |
University Hospital of Schleswig-Holstein | Recruiting |
Luebeck, Germany | |
Contact: Matthias Heringlake | |
University Hospital Magdeburg | Recruiting |
Magdeburg, Germany | |
Contact: Thomas Hachenberg | |
University Hospital Rostock | Recruiting |
Rostock, Germany | |
Contact: Jan Roesner | |
University Hospital Wuerzburg | Recruiting |
Wuerzburg, Germany |
Principal Investigator: | Patrick Meybohm, MD | University of Schleswig-Holstein |
Principal Investigator: | Berthold Bein, MD, DESA | University of Schleswig-Holstein |
Principal Investigator: | Jochen Cremer, MD | University of Schleswig-Holstein |
Principal Investigator: | Kai Zacharowski, MD, PhD | University Hospital Frankfurt am Main |
![](https://webarchive.library.unt.edu/web/20121019014426im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided by University of Schleswig-Holstein
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Patrick Meybohm, PD Dr Patrick Meybohm, University of Schleswig-Holstein |
ClinicalTrials.gov Identifier: | NCT01067703 History of Changes |
Other Study ID Numbers: | ME 3559/1-1 |
Study First Received: | February 10, 2010 |
Last Updated: | November 30, 2011 |
Health Authority: | Germany: Ethics Commission |
Keywords provided by University of Schleswig-Holstein:
remote ischaemic preconditioning, cardiac surgery |
ClinicalTrials.gov processed this record on October 17, 2012