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

NCT ID: NCT01427621

Last Updated: 2011-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Valve Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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RIPCcom group

Group Type EXPERIMENTAL

remote ischemic pre and postconditioning (RIPC)

Intervention Type PROCEDURE

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.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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combined intervention of remote ischemic preconditioning and remote ischemic postconditioning.

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Young-Lan Kwak, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine

References

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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.

Reference Type DERIVED
PMID: 22281799 (View on PubMed)

Other Identifiers

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4-2009-0648

Identifier Type: -

Identifier Source: org_study_id

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