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Remote Ischaemic Preconditioning for Heart Surgery (RIPHeart-Study)

NCT01067703 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1400

Last updated 2015-12-03

No results posted yet for this study

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.

Conditions

  • Myocardial Injury
  • Mortality

Interventions

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.

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER

  • Goethe University

    collaborator OTHER

  • University Hospital Schleswig-Holstein

    lead OTHER

Principal Investigators

  • Patrick Meybohm, MD · University Hospital Frankfurt/ University Hospital Schleswig-Holstein

  • Berthold Bein, MD, DESA · University Hospital Schleswig-Holstein

  • Jochen Cremer, MD · University Hospital Schleswig-Holstein

  • Kai Zacharowski, MD, PhD · University Hospital Frankfurt am Main

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2014-05-31
Completion
2015-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01067703 on ClinicalTrials.gov