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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

Tracking Information
First Submitted Date  ICMJE February 10, 2010
First Posted Date  ICMJE February 11, 2010
Last Update Posted Date December 3, 2015
Study Start Date  ICMJE December 2010
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2013)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2010)
Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure [ Time Frame: Postoperative 30 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2011)
  • Occurence of any component of the composite outcome [ Time Frame: Postoperative hospital discharge, 3 months, 12 months ]
  • length of stay on the intensive care unit [ Time Frame: Postoperative during hospital stay ]
  • total hospital stay [ Time Frame: hospital discharge ]
  • new onset of atrial fibrillation [ Time Frame: In-hospital ]
  • Delirium [ Time Frame: Postoperative 24, 48, 72, 96 hrs ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2010)
  • Occurence of any componet of the composite [ Time Frame: Postoperative hospital discharge, 3 months, 12 months ]
  • length of stay on the intensive care unit [ Time Frame: Postoperative during hospital stay ]
  • total hospital stay [ Time Frame: hospital discharge ]
  • new onset of atrial fibrillation [ Time Frame: Postoperative 30 days ]
  • Delirium [ Time Frame: Postoperative 24, 48, 72, 96 hrs ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)
Official Title  ICMJE Remote Ischaemic Preconditioning for Heart Surgery
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Myocardial Injury
  • Mortality
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: RIPC
    Intervention: Procedure: Remote Ischemic Preconditioning
  • Sham Comparator: CONTROL
    Intervention: Procedure: Control/sham procedure (blood pressure cuff)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 1, 2014)
1400
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2010)
2070
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01067703
Other Study ID Numbers  ICMJE ME 3559/1-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Patrick Meybohm, University Hospital Schleswig-Holstein
Study Sponsor  ICMJE University Hospital Schleswig-Holstein
Collaborators  ICMJE
  • German Research Foundation
  • University Hospital, Frankfurt
Investigators  ICMJE
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
PRS Account University Hospital Schleswig-Holstein
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP