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Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)

NCT ID: NCT01067703

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2015-05-31

Brief Summary

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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

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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.

Conditions

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Myocardial Injury Mortality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RIPC

Group Type ACTIVE_COMPARATOR

Remote Ischemic Preconditioning

Intervention Type PROCEDURE

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.

CONTROL

Group Type SHAM_COMPARATOR

Control/sham procedure (blood pressure cuff)

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

Goethe University

OTHER

Sponsor Role collaborator

University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Responsible Party

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Patrick Meybohm

Prof. Dr. Patrick Meybohm

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick Meybohm, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Frankfurt/ University Hospital Schleswig-Holstein

Berthold Bein, MD, DESA

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein

Jochen Cremer, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein

Kai Zacharowski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Frankfurt am Main

Locations

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University Hospital Aachen (RWTH)

Aachen, , Germany

Site Status

University Hospital Charite

Berlin, , Germany

Site Status

University Hospital Bonn

Bonn, , Germany

Site Status

University Hospital Frankfurt/M

Frankfurt/M, , Germany

Site Status

University Hospital Goettingen

Göttingen, , Germany

Site Status

University Hospital Schleswig-Holstein

Kiel, , Germany

Site Status

University Hospital of Schleswig-Holstein

Lübeck, , Germany

Site Status

University Hospital Magdeburg

Magdeburg, , Germany

Site Status

University Hospital Rostock

Rostock, , Germany

Site Status

University Hospital Wuerzburg

Würzburg, , Germany

Site Status

Countries

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Germany

References

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Meybohm P, Bein B, Brosteanu O, Cremer J, Gruenewald M, Stoppe C, Coburn M, Schaelte G, Boning 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, Schon 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.

Reference Type RESULT
PMID: 26436208 (View on PubMed)

Meybohm P, Zacharowski K, Cremer J, Roesner J, Kletzin F, Schaelte G, Felzen M, Strouhal U, Reyher C, Heringlake M, Schon 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.

Reference Type RESULT
PMID: 22880214 (View on PubMed)

Westphal S, Stoppe C, Gruenewald M, Bein B, Renner J, Cremer J, Coburn M, Schaelte G, Boening A, Niemann B, Kletzin F, Roesner J, Strouhal U, Reyher C, Laufenberg-Feldmann R, Ferner M, Brandes IF, Bauer M, Kortgen A, Stehr SN, Wittmann M, Baumgarten G, Struck R, Meyer-Treschan T, Kienbaum P, Heringlake M, Schoen J, Sander M, Treskatsch S, Smul T, Wolwender E, Schilling T, Degenhardt F, Franke A, Mucha S, Tittmann L, Kohlhaas M, Fuernau G, Brosteanu O, Hasenclever D, Zacharowski K, Meybohm P; RIPHeart-Study Collaborators. Genome-wide association study of myocardial infarction, atrial fibrillation, acute stroke, acute kidney injury and delirium after cardiac surgery - a sub-analysis of the RIPHeart-Study. BMC Cardiovasc Disord. 2019 Jan 24;19(1):26. doi: 10.1186/s12872-019-1002-x.

Reference Type DERIVED
PMID: 30678657 (View on PubMed)

Meybohm P, Kohlhaas M, Stoppe C, Gruenewald M, Renner J, Bein B, Albrecht M, Cremer J, Coburn M, Schaelte G, Boening A, Niemann B, Sander M, Roesner J, Kletzin F, Mutlak H, Westphal S, Laufenberg-Feldmann R, Ferner M, Brandes IF, Bauer M, Stehr SN, Kortgen A, Wittmann M, Baumgarten G, Meyer-Treschan T, Kienbaum P, Heringlake M, Schoen J, Treskatsch S, Smul T, Wolwender E, Schilling T, Fuernau G, Bogatsch H, Brosteanu O, Hasenclever D, Zacharowski K; RIPHeart (Remote Ischemic Preconditioning for Heart Surgery) Study Collaborators. RIPHeart (Remote Ischemic Preconditioning for Heart Surgery) Study: Myocardial Dysfunction, Postoperative Neurocognitive Dysfunction, and 1 Year Follow-Up. J Am Heart Assoc. 2018 Mar 26;7(7):e008077. doi: 10.1161/JAHA.117.008077.

Reference Type DERIVED
PMID: 29581218 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25252696 (View on PubMed)

Other Identifiers

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ME 3559/1-1

Identifier Type: -

Identifier Source: org_study_id