Cardiopulmonary Protective Effects of Modified Remote Ischaemic Preconditioning in Mitral Valve Replacement Surgery

March 15, 2018 updated by: Su Liu, Xuzhou Medical University

Cardiopulmonary Protection of Modified Remote Ischaemic Preconditioning in Mitral Valve Replacement Surgery

During cardiac surgery with cardiopulmonary bypass , injury occurs to the heart muscle and the lung.The heart and lung injury is a serious complication ,which increases both mortality and morbidity of cardiac surgery .Remote ischemic preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive strategy.Recent some trials suggested that RIPC could provide myocardial protection by reducing serum cardiac biomarkers,however, more recent multicenter studies[9-11] had failed to show the protective effects of RIPC with respect to the troponin release and lung injury.

Remote ischemic preconditioning (RIPC) is reported to have the early-phase and delayed-phase organ protective effects, whether the modified RIPC protocol induced repeatedly has the cardiopulmonary protective effect is still uncertain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

modified RIPC was induced at 24 h, 12 h and 1 h before surgery to reinforce the protective effects of RIPC.The single RIPC protocol was induced by three cycles of upper-limb ischemia, a standard blood-pressure cuff was placed on the ringt upper arm, then inflated the cuff to 200 mm Hg for 5 minutes, followed by 5 min of cuff deflation.

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • The Affiliated Hospital of Xuzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients undergoing heart surgery on cardiopulmonary bypass
  2. Patients aged 18 years to 80 years

Exclusion Criteria:

  1. Inability to give informed consent
  2. Cardiogenic shock
  3. Cardiac arrest on current admission
  4. Left ventricular ejection fraction less than 30%
  5. Current atrial fibrillation
  6. Preoperative use of inotropics or mechanical assist device
  7. Patients with significant hepatic dysfunction (Prothrombin>2.0 ratio)
  8. Patients with known renal failure with a GFR<30 mL/min/1.73 m2
  9. Patients with significant pulmonary disease (FEV1<40% predicted)
  10. Recent myocardial infarction (within 7 days)
  11. Recent systemic infection or sepsis (within 7 days)
  12. Severe stroke (within 2 months)
  13. Significant peripheral arterial disease affecting the upper limbs
  14. Previous serious psychiatric disorders (e.g. schizophrenia, dementia)
  15. Surgeries: cardiac transplantation, concomitant carotid endarterectomy , previous heart surgery,off-pump surgery, emergency surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Modified Remote Ischemic Preconditioning(mRIPC)
modified RIPC was induced at 24 h, 12 h and 1 h before surgery to reinforce the protective effects of RIPC. The single RIPC protocol was induced by three cycles of upper-limb ischemia, a standard blood-pressure cuff was placed on the ringt upper arm, then inflated the cuff to 200 mm Hg for 5 minutes, followed by 5 min of cuff deflation.
Procedure: Modified Remote Ischemic Preconditioning
mRIPC will be induced at 24 h, 12 h and 1 h before surgery and once before induction of anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200mmHg
Other Names:
  • mRIPC
Placebo Comparator: Control
Control group without remote ischemic preconditioning
Procedure: Control
Control group witnout remote ischemic preconditioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Troponin I serum release over 24 hours after surgery
Time Frame: 24 hours post surgery
24 hours post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
PaO2/FiO2 ratio over 24 hours after surgery
Time Frame: 24 hours post surgery
24 hours post surgery
salveolar-arterial oxygen gradient over 24 hours after surgery
Time Frame: 24 hours post surgery
24 hours post surgery
Inotrope score
Time Frame: 12 hours post surgery
12 hours post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xuzhou Medical University

Investigators

  • Principal Investigator: Liu Su, M.D/Ph.D, The Affiliated Hospital of Xuzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2016

Primary Completion (Actual)

January 10, 2018

Study Completion (Actual)

March 10, 2018

Study Registration Dates

First Submitted

December 31, 2016

First Submitted That Met QC Criteria

January 3, 2017

First Posted (Estimate)

January 5, 2017

Study Record Updates

Last Update Posted (Actual)

March 19, 2018

Last Update Submitted That Met QC Criteria

March 15, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYFY-2017-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD will be available when this trial is finished and the article have been published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Injury

Clinical Trials on Modified Remote Ischemic Preconditioning

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe