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Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)

This study is currently recruiting participants.
Verified February 2013 by University of Schleswig-Holstein
Sponsor:
Collaborators:
German Research Foundation
University Hospital, Frankfurt
Information provided by (Responsible Party):
Patrick Meybohm, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT01067703
First received: February 10, 2010
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by University of Schleswig-Holstein:

Primary Outcome Measures:
  • 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 ]
    Time frame until hospital discharge


Secondary Outcome Measures:
  • 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 2016
Estimated Primary Completion Date: April 2016 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067703

Contacts
Contact: Patrick Meybohm, MD meybohm@anaesthesie.uni-kiel.de

Locations
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
Sponsors and Collaborators
University of Schleswig-Holstein
German Research Foundation
University Hospital, Frankfurt
Investigators
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
  More Information

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: February 28, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University of Schleswig-Holstein:
remote ischaemic preconditioning, cardiac surgery

ClinicalTrials.gov processed this record on May 23, 2013