Remote Ischemic Preconditioning on Pulmonary Injury in Cardic Surgery

February 19, 2017 updated by: Su Liu, Xuzhou Medical University

Effect of Remote Ischemic Preconditioning on Pulmonary Injury in Cardic Surgery

During cardiac surgery with cardiopulmonary bypass , pulmonary dysfunction remains to be a problem complicating the postoperative course of the patients.Remote ischemic preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive strategy.Recent several trials suggested that RIPC could provide pulmonary protection by reducing serum biomarkers,however,whether the RIPC can improve the clinical outcomes in patients undergoing on-pump cardiac surgery,is still uncertain.

The study hypothesis is: remote ischemic preconditioning will provide lung-protective effect and improve clinical outcomes in patients undergoing cardic surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Remote ischemic preconditioning (RIPC) protocol will be induced during anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood pressure cuff inflated to a pressure 200mmHg

Study Type

Interventional

Enrollment (Anticipated)

60

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 Contact

  • Name: Liu Su, M.D/Ph.D
  • Phone Number: +86-18118309692
  • Email: xyfymzk@163.com

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • Recruiting
        • 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

16 years to 78 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. Preoperative severe impairment of respiratory function (arterial oxygen tension (PaO2) <60 mmHg or FEV1<50% predicted)
  3. Prior receipt of chemotherapy or radiation therapy or immunotherapy
  4. left ventricular ejection fraction less than 30%
  5. preoperative use of inotropics or mechanical assist device
  6. Patients with significant hepatic dysfunction (Prothrombin>2.0 ratio)
  7. Patients with known renal failure with a GFR<30 mL/min/1.73 m2
  8. recent myocardial infarction (within 7 days)
  9. Systemic or local active infections (either clinically defined or suggested by evidence such as elevated C-reactive protein levels, leukocytosis, or a body temperature>38℃)
  10. Significant peripheral arterial disease affecting the upper limbs
  11. 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Control group without remote ischemic preconditioning
Procedure: Control
Control group witnout remote ischemic preconditioning
Active Comparator: Remote Ischemic Preconditioning(RIPC)
3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200mmHg will be given to RIPC
Procedure: Remote Ischemic Preconditioning
RIPC will be induced during 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:
  • RIPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of PaO2/FiO2 over 24 hours after cardiac surgery
Time Frame: 24 hours post surgery
24 hours post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: 30 days post surgery
30 days post surgery
Postoperative Pulmonary Complications
Time Frame: 30 days post surgery
30 days 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)

February 7, 2017

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

January 7, 2017

First Submitted That Met QC Criteria

January 7, 2017

First Posted (Estimate)

January 10, 2017

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYFY-2017-004

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

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.

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