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

Heart Valve Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427621
• Other study ID #: 4-2009-0648
• Status: Completed
• Phase: Phase 4
• First received: August 30, 2011
• Last updated: August 31, 2011
• Start date: March 2010
• Est. completion date: May 2011

Study information

• Verified date: August 2011
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Valve Diseases
• Lung Injury

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of postoperative PaO2/FiO2	Comparison of postoperative PaO2/FiO2 between RIPCcom group and Control group.	at 10 minutes after anesthetic induction	No