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

Tracking Information

First Received Date ^ICMJE

February 10, 2010

Last Updated Date

February 28, 2013

Start Date ^ICMJE

December 2010

Estimated Primary Completion Date

April 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT01067703 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Arm (s)

Active Comparator: RIPC
Intervention: Procedure: Remote Ischemic Preconditioning
Sham Comparator: CONTROL
Intervention: Procedure: Control/sham procedure (blood pressure cuff)

Publications *

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.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

2070

Estimated Completion Date

April 2016

Estimated Primary Completion Date

April 2016 (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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Patrick Meybohm, MD

meybohm@anaesthesie.uni-kiel.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01067703

Other Study ID Numbers ^ICMJE

ME 3559/1-1

Has Data Monitoring Committee

Yes

Responsible Party

Patrick Meybohm, University of Schleswig-Holstein

Study Sponsor ^ICMJE

University of Schleswig-Holstein

Collaborators ^ICMJE

German Research Foundation
University Hospital, Frankfurt

Investigators ^ICMJE

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

Information Provided By

University of Schleswig-Holstein

Verification Date

February 2013

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

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