Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)

This study has been terminated.
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: September 1, 2014
Last verified: September 2014

February 10, 2010
September 1, 2014
December 2010
May 2014   (final data collection date for primary outcome measure)
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
Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure [ Time Frame: Postoperative 30 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01067703 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Occurence of any componet of the composite [ 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: Postoperative 30 days ] [ Designated as safety issue: No ]
  • Delirium [ Time Frame: Postoperative 24, 48, 72, 96 hrs ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)
Remote Ischaemic Preconditioning for Heart Surgery

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Myocardial Injury
  • Mortality
  • 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.
  • Active Comparator: RIPC
    Intervention: Procedure: Remote Ischemic Preconditioning
  • Sham Comparator: CONTROL
    Intervention: Procedure: Control/sham procedure (blood pressure cuff)
Meybohm P, Zacharowski K, Cremer J, Roesner J, Kletzin F, Schaelte G, Felzen M, Strouhal U, Reyher C, Heringlake M, Schön J, Brandes I, Bauer M, Knuefermann P, Wittmann M, Hachenberg T, Schilling T, Smul T, Maisch S, Sander M, Moormann T, Boening A, Weigand MA, Laufenberg R, Werner C, Winterhalter M, Treschan T, Stehr SN, Reinhart K, Hasenclever D, Brosteanu O, Bein B; RIP Heart-Study Investigator Group. Remote ischaemic preconditioning for heart surgery. The study design for a multi-center randomized double-blinded controlled clinical trial--the RIPHeart-Study. Eur Heart J. 2012 Jun;33(12):1423-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1400
May 2015
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01067703
ME 3559/1-1
Yes
Patrick Meybohm, University of Schleswig-Holstein
University of Schleswig-Holstein
  • German Research Foundation
  • University Hospital, Frankfurt
Principal Investigator: Patrick Meybohm, MD University Hospital Frankfurt/ University Hospital 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
University of Schleswig-Holstein
September 2014

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