search
Back to results

Effect of Combined Remote Ischemic Preconditioning and Postconditioning on Acute Pulmonary Injury in Patients Undergoing Valvular Heart Surgery

Primary Purpose

Heart Valve Diseases

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
remote ischemic pre and postconditioning (RIPC)
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Valve Diseases

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients undergoing valvular heart surgery.
  • Age: 20~80.

Exclusion Criteria:

  • Emergency operation.
  • patients with peripheral vascular disease.
  • Patients with a known history or clinical evidence of chronic obstructive pulmonary disease.
  • Patients with hepatic or renal dysfunction
  • Patients with acute myocardial infarction within 1 week before surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    RIPCcom group

    Control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Comparison of postoperative PaO2/FiO2
    Comparison of postoperative PaO2/FiO2 between RIPCcom group and Control group.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 30, 2011
    Last Updated
    August 31, 2011
    Sponsor
    Yonsei University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01427621
    Brief Title
    Effect of Combined Remote Ischemic Preconditioning and Postconditioning on Acute Pulmonary Injury in Patients Undergoing Valvular Heart Surgery
    Official Title
    Effect of Combined Remote Ischemic Preconditioning and Postconditioning on Acute Pulmonary Injury in Patients Undergoing Valvular Heart Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2010 (undefined)
    Primary Completion Date
    November 2010 (Actual)
    Study Completion Date
    May 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yonsei University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Pulmonary dysfunction after cardiac surgery with CPB remains to be a problem complicating the postoperative course of the patients. The investigators hypothesized that RIPCcom, combined intervention of remote ischemic preconditioning and remote ischemic postconditioning, would confer beneficial influence on inflammatory response and resultant postoperative pulmonary dysfunction after CPB in patients undergoing complex valvular heart surgery who are at increased risk of postoperative pulmonary dysfunction.The aim of this study was to evaluate the lung-protective effect of combined remote ischemic pre- and post-conditioning in patients undergoing complex valvular heart surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Valve Diseases

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    RIPCcom group
    Arm Type
    Experimental
    Arm Title
    Control group
    Arm Type
    No Intervention
    Intervention Type
    Procedure
    Intervention Name(s)
    remote ischemic pre and postconditioning (RIPC)
    Other Intervention Name(s)
    combined intervention of remote ischemic preconditioning and remote ischemic postconditioning.
    Intervention Description
    RIPCcom group: combined intervention of remote ischemic pre- and postconditioning consisted of three 10-minute cycles of right lower limb ischemia, which was induced with an automated cuff-inflator placed on the right upper leg and inflated to 250 mmHg, with an intervening 10 minute of reperfusion during which the cuff was deflated. This intervention were performed at 10 minutes after induction of anesthesia and then 10 min after weaning from CPB.
    Primary Outcome Measure Information:
    Title
    Comparison of postoperative PaO2/FiO2
    Description
    Comparison of postoperative PaO2/FiO2 between RIPCcom group and Control group.
    Time Frame
    at 10 minutes after anesthetic induction

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients undergoing valvular heart surgery. Age: 20~80. Exclusion Criteria: Emergency operation. patients with peripheral vascular disease. Patients with a known history or clinical evidence of chronic obstructive pulmonary disease. Patients with hepatic or renal dysfunction Patients with acute myocardial infarction within 1 week before surgery
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Young-Lan Kwak, MD, Ph.D
    Organizational Affiliation
    Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22281799
    Citation
    Kim JC, Shim JK, Lee S, Yoo YC, Yang SY, Kwak YL. Effect of combined remote ischemic preconditioning and postconditioning on pulmonary function in valvular heart surgery. Chest. 2012 Aug;142(2):467-475. doi: 10.1378/chest.11-2246.
    Results Reference
    derived

    Learn more about this trial

    Effect of Combined Remote Ischemic Preconditioning and Postconditioning on Acute Pulmonary Injury in Patients Undergoing Valvular Heart Surgery

    We'll reach out to this number within 24 hrs