Effect of Combined Remote Ischemic Preconditioning and Postconditioning on Acute Pulmonary Injury in Patients Undergoing Valvular Heart Surgery
1 other identifier
interventional
54
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 30, 2011
CompletedFirst Posted
Study publicly available on registry
September 1, 2011
CompletedSeptember 1, 2011
August 1, 2011
8 months
August 30, 2011
August 31, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of postoperative PaO2/FiO2
Comparison of postoperative PaO2/FiO2 between RIPCcom group and Control group.
at 10 minutes after anesthetic induction
Study Arms (2)
RIPCcom group
EXPERIMENTALControl group
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- patients undergoing valvular heart surgery.
- Age: 20\~80.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 22281799DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young-Lan Kwak, MD, Ph.D
Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2011
First Posted
September 1, 2011
Study Start
March 1, 2010
Primary Completion
November 1, 2010
Study Completion
May 1, 2011
Last Updated
September 1, 2011
Record last verified: 2011-08