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Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01067703
Recruitment Status : Terminated
First Posted : February 11, 2010
Last Update Posted : December 3, 2015
Sponsor:
Collaborators:
German Research Foundation
University Hospital, Frankfurt
Information provided by (Responsible Party):
Patrick Meybohm, University Hospital Schleswig-Holstein

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Myocardial Injury Mortality Procedure: Remote Ischemic Preconditioning Procedure: Control/sham procedure (blood pressure cuff) Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Remote Ischaemic Preconditioning for Heart Surgery
Study Start Date : December 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure [ Time Frame: In-hospital ]
    Time frame until hospital discharge


Secondary Outcome Measures :
  1. Occurence of any component of the composite outcome [ Time Frame: Postoperative hospital discharge, 3 months, 12 months ]
  2. length of stay on the intensive care unit [ Time Frame: Postoperative during hospital stay ]
  3. total hospital stay [ Time Frame: hospital discharge ]
  4. new onset of atrial fibrillation [ Time Frame: In-hospital ]
  5. Delirium [ Time Frame: Postoperative 24, 48, 72, 96 hrs ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067703


Locations
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Germany
University Hospital Aachen (RWTH)
Aachen, Germany
University Hospital Charite
Berlin, Germany
University Hospital Bonn
Bonn, Germany
University Hospital Frankfurt/M
Frankfurt/M, Germany
University Hospital Goettingen
Goettingen, Germany
University Hospital Schleswig-Holstein
Kiel, Germany
University Hospital of Schleswig-Holstein
Luebeck, Germany
University Hospital Magdeburg
Magdeburg, Germany
University Hospital Rostock
Rostock, Germany
University Hospital Wuerzburg
Wuerzburg, Germany
Sponsors and Collaborators
University Hospital Schleswig-Holstein
German Research Foundation
University Hospital, Frankfurt
Investigators
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Principal Investigator: Patrick Meybohm, MD University Hospital Frankfurt/ University Hospital Schleswig-Holstein
Principal Investigator: Berthold Bein, MD, DESA University Hospital Schleswig-Holstein
Principal Investigator: Jochen Cremer, MD University Hospital Schleswig-Holstein
Principal Investigator: Kai Zacharowski, MD, PhD University Hospital Frankfurt am Main
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Patrick Meybohm, Prof. Dr. Patrick Meybohm, University Hospital Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT01067703    
Other Study ID Numbers: ME 3559/1-1
First Posted: February 11, 2010    Key Record Dates
Last Update Posted: December 3, 2015
Last Verified: September 2014
Keywords provided by Patrick Meybohm, University Hospital Schleswig-Holstein:
remote ischaemic preconditioning, cardiac surgery
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes