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

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ClinicalTrials.gov Identifier: NCT01427621
Recruitment Status : Completed
First Posted : September 1, 2011
Last Update Posted : September 1, 2011
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : March 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Comparison of postoperative PaO2/FiO2 [ Time Frame: at 10 minutes after anesthetic induction ]
    Comparison of postoperative PaO2/FiO2 between RIPCcom group and Control group.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 1, 2011    Key Record Dates
Last Update Posted: September 1, 2011
Last Verified: August 2011

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