Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study) - Full Text View

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 ]


Enrollment:	1400
Study Start Date:	December 2010
Study Completion Date:	May 2015
Primary Completion Date:	May 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.

Eligibility


Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067703

Locations


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 of Schleswig-Holstein

German Research Foundation

University Hospital, Frankfurt

Investigators


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

More Information

Publications:

Meybohm P, Bein B, Brosteanu O, Cremer J, Gruenewald M, Stoppe C, Coburn M, Schaelte G, Böning A, Niemann B, Roesner J, Kletzin F, Strouhal U, Reyher C, Laufenberg-Feldmann R, Ferner M, Brandes IF, Bauer M, Stehr SN, Kortgen A, Wittmann M, Baumgarten G, Meyer-Treschan T, Kienbaum P, Heringlake M, Schön J, Sander M, Treskatsch S, Smul T, Wolwender E, Schilling T, Fuernau G, Hasenclever D, Zacharowski K; RIPHeart Study Collaborators. A Multicenter Trial of Remote Ischemic Preconditioning for Heart Surgery. N Engl J Med. 2015 Oct 8;373(15):1397-407. doi: 10.1056/NEJMoa1413579. Epub 2015 Oct 5.

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.

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

Candilio L, Malik A, Ariti C, Barnard M, Di Salvo C, Lawrence D, Hayward M, Yap J, Roberts N, Sheikh A, Kolvekar S, Hausenloy DJ, Yellon DM. Effect of remote ischaemic preconditioning on clinical outcomes in patients undergoing cardiac bypass surgery: a randomised controlled clinical trial. Heart. 2015 Feb;101(3):185-92. doi: 10.1136/heartjnl-2014-306178. Epub 2014 Sep 24.


Responsible Party:	Patrick Meybohm, Prof. 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:	December 1, 2015
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Schleswig-Holstein:


remote ischaemic preconditioning, cardiac surgery

ClinicalTrials.gov processed this record on September 26, 2016