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Effect of Remote Ischemic Perconditioning on Acute Kidney Injury in Adult Valve Replace

Primary Purpose

Rheumatic Disease of Heart Valve, Ischemic Reperfusion Injury

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Remote ischemic postconditioning
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rheumatic Disease of Heart Valve focused on measuring Ischemia reperfusion injury, Cardiopulmonary bypass, Remote Ischemic Postconditioning, Other Functional Disturbances Following Cardiac Surgery

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • rheumatic heart valve disease requiring selective aortic or double valve(aortic and mitral valve) replacement

Exclusion Criteria:

  • infective endocarditis congenital valve disease previous cardiac surgery complicated with rereplace valve
  • Renal dysfunction
  • diabetes
  • coronary artery disease
  • hypertension
  • peripheral vascular disease affecting the lower limb free of arteriovenous fistula
  • receiving aspirin, corticosteroids, angiotensin-converting enzyme inhibitors or statin perioperatively

Sites / Locations

  • Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Manual Tourniquet

Arm Description

Outcomes

Primary Outcome Measures

Renal function

Secondary Outcome Measures

concentration of troponin I (cTnI)
Myocardial enzyme
Cystatin C
High-sensitivity c-reactive protein(HS-CRP)

Full Information

First Posted
November 16, 2011
Last Updated
August 11, 2012
Sponsor
Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT01476969
Brief Title
Effect of Remote Ischemic Perconditioning on Acute Kidney Injury in Adult Valve Replace
Official Title
Effect of Remote Ischemic Perconditioning on Acute Kidney Injury in Adult Valve Replace
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether Remote Ischemic Perconditioning is effective on Acute kidney injury in adult valve replacement.
Detailed Description
Methods: Patients meeting the requirement will be randomized into 2 groups: the treatment group consisted of three 5-minute cycles left lower limb ischemia, induced by inflating a blood pressure cuff on the lower limb to 600 mmHg with an intervening 5 minutes of reperfusion, during which time the cuff was deflate; the control group consisted of placing an uninflated cuff on the left lower limb for 30 minutes. The postconditioning protocol was applied after the aortic cross-clamping. The clinical data of inotropes requirement, drainage, ventilation and intensive care time will be recorded. Venous blood samples will be taken perioperatively for detecting concentration of troponin I (cTnI), Myocardial enzyme, Renal function, Cystatin c, and High-sensitivity c-reactive protein(HS-CRP).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Disease of Heart Valve, Ischemic Reperfusion Injury
Keywords
Ischemia reperfusion injury, Cardiopulmonary bypass, Remote Ischemic Postconditioning, Other Functional Disturbances Following Cardiac Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual Tourniquet
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Remote ischemic postconditioning
Other Intervention Name(s)
Manual Tourniquet YZ-01
Intervention Description
the treatment group consisted of three 4-minute cycles left lower limb ischemia,induced by inflating a blood pressure cuff on the lower limb to 600 mmHg with an intervening 4 minutes of reperfusion ,during which time the cuff was deflate;the control group consisted of placing an uninflated cuff on the left lower limb for 24 minutes.The postconditioning protocol was applied after the aortic cross-clamping.
Primary Outcome Measure Information:
Title
Renal function
Time Frame
within the first 48h after cardiac surgery
Secondary Outcome Measure Information:
Title
concentration of troponin I (cTnI)
Time Frame
within 48h after cardiac surgery
Title
Myocardial enzyme
Time Frame
within 48h after cardiac surgery
Title
Cystatin C
Time Frame
within 48h after cardiac surgery
Title
High-sensitivity c-reactive protein(HS-CRP)
Time Frame
within 48h after cardiac surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: rheumatic heart valve disease requiring selective aortic or double valve(aortic and mitral valve) replacement Exclusion Criteria: infective endocarditis congenital valve disease previous cardiac surgery complicated with rereplace valve Renal dysfunction diabetes coronary artery disease hypertension peripheral vascular disease affecting the lower limb free of arteriovenous fistula receiving aspirin, corticosteroids, angiotensin-converting enzyme inhibitors or statin perioperatively
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luo Wanjun, M.D.
Phone
86-731-89753503
Email
luo3478@yahoo.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lv Hongwei, M.D.
Phone
86-13467616975
Email
hongweilv@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luo Wanjun, M.D.
Organizational Affiliation
Central South University
Official's Role
Study Director
Facility Information:
Facility Name
Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luo Wanjun, M.D.
Phone
86-731-89753503
Email
luo3478@yahoo.cn
First Name & Middle Initial & Last Name & Degree
Lv Hongwei, M.D.
Phone
86-13467616975
Email
hongweilv@163.com
First Name & Middle Initial & Last Name & Degree
Luo Wanjun, M.D.
First Name & Middle Initial & Last Name & Degree
Lv Hongwei, M.D.

12. IPD Sharing Statement

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Effect of Remote Ischemic Perconditioning on Acute Kidney Injury in Adult Valve Replace

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