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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01427621
First received: August 30, 2011
Last updated: August 31, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Heart Valve Diseases
Procedure: remote ischemic pre and postconditioning (RIPC)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Combined Remote Ischemic Preconditioning and Postconditioning on Acute Pulmonary Injury in Patients Undergoing Valvular Heart Surgery

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Comparison of postoperative PaO2/FiO2 [ Time Frame: at 10 minutes after anesthetic induction ] [ Designated as safety issue: No ]
    Comparison of postoperative PaO2/FiO2 between RIPCcom group and Control group.


Enrollment: 54
Study Start Date: March 2010
Study Completion Date: May 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RIPCcom group Procedure: remote ischemic pre and postconditioning (RIPC)
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.
Other Name: combined intervention of remote ischemic preconditioning and remote ischemic postconditioning.
No Intervention: Control group

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01427621

Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Young-Lan Kwak, MD, Ph.D Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
  More Information

No publications provided by Yonsei University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01427621     History of Changes
Other Study ID Numbers: 4-2009-0648
Study First Received: August 30, 2011
Last Updated: August 31, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Heart Valve Diseases
Lung Injury
Heart Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 30, 2014