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Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)

Primary Purpose

Myocardial Injury, Mortality

Status
Terminated
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Remote Ischemic Preconditioning
Control/sham procedure (blood pressure cuff)
Sponsored by
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Injury focused on measuring remote ischaemic preconditioning, cardiac surgery

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Aachen (RWTH)
  • University Hospital Charite
  • University Hospital Bonn
  • University Hospital Frankfurt/M
  • University Hospital Goettingen
  • University Hospital Schleswig-Holstein
  • University Hospital of Schleswig-Holstein
  • University Hospital Magdeburg
  • University Hospital Rostock
  • University Hospital Wuerzburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

RIPC

CONTROL

Arm Description

Outcomes

Primary Outcome Measures

Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure
Time frame until hospital discharge

Secondary Outcome Measures

Occurence of any component of the composite outcome
length of stay on the intensive care unit
total hospital stay
new onset of atrial fibrillation
Delirium

Full Information

First Posted
February 10, 2010
Last Updated
December 1, 2015
Sponsor
University Hospital Schleswig-Holstein
Collaborators
German Research Foundation, Goethe University
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1. Study Identification

Unique Protocol Identification Number
NCT01067703
Brief Title
Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)
Official Title
Remote Ischaemic Preconditioning for Heart Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Study Start Date
December 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein
Collaborators
German Research Foundation, Goethe University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Injury, Mortality
Keywords
remote ischaemic preconditioning, cardiac surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RIPC
Arm Type
Active Comparator
Arm Title
CONTROL
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Remote Ischemic Preconditioning
Intervention Description
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
Intervention Name(s)
Control/sham procedure (blood pressure cuff)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite of all-cause mortality, non-fatal myocardial infarction, any new stroke, and/or acute renal failure
Description
Time frame until hospital discharge
Time Frame
In-hospital
Secondary Outcome Measure Information:
Title
Occurence of any component of the composite outcome
Time Frame
Postoperative hospital discharge, 3 months, 12 months
Title
length of stay on the intensive care unit
Time Frame
Postoperative during hospital stay
Title
total hospital stay
Time Frame
hospital discharge
Title
new onset of atrial fibrillation
Time Frame
In-hospital
Title
Delirium
Time Frame
Postoperative 24, 48, 72, 96 hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Meybohm, MD
Organizational Affiliation
University Hospital Frankfurt/ University Hospital Schleswig-Holstein
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Berthold Bein, MD, DESA
Organizational Affiliation
University Hospital Schleswig-Holstein
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jochen Cremer, MD
Organizational Affiliation
University Hospital Schleswig-Holstein
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kai Zacharowski, MD, PhD
Organizational Affiliation
University Hospital Frankfurt am Main
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Aachen (RWTH)
City
Aachen
Country
Germany
Facility Name
University Hospital Charite
City
Berlin
Country
Germany
Facility Name
University Hospital Bonn
City
Bonn
Country
Germany
Facility Name
University Hospital Frankfurt/M
City
Frankfurt/M
Country
Germany
Facility Name
University Hospital Goettingen
City
Goettingen
Country
Germany
Facility Name
University Hospital Schleswig-Holstein
City
Kiel
Country
Germany
Facility Name
University Hospital of Schleswig-Holstein
City
Luebeck
Country
Germany
Facility Name
University Hospital Magdeburg
City
Magdeburg
Country
Germany
Facility Name
University Hospital Rostock
City
Rostock
Country
Germany
Facility Name
University Hospital Wuerzburg
City
Wuerzburg
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26436208
Citation
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.
Results Reference
result
PubMed Identifier
22880214
Citation
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.
Results Reference
result
PubMed Identifier
30678657
Citation
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.
Results Reference
derived
PubMed Identifier
29581218
Citation
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.
Results Reference
derived
PubMed Identifier
25252696
Citation
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.
Results Reference
derived

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Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)

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