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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01476969
Other study ID # CentralSouthU
Secondary ID
Status Recruiting
Phase N/A
First received November 16, 2011
Last updated August 11, 2012
Start date September 2011
Est. completion date November 2012

Study information

Verified date August 2012
Source Central South University
Contact Luo Wanjun, M.D.
Phone 86-731-89753503
Email luo3478@yahoo.cn
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Remote Ischemic Perconditioning is effective on Acute kidney injury in adult valve replacement.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Device:
Remote ischemic postconditioning
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.

Locations

Country Name City State
China Central South University Changsha Hunan

Sponsors (1)

Lead Sponsor Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Renal function within the first 48h after cardiac surgery No
Secondary concentration of troponin I (cTnI) within 48h after cardiac surgery No
Secondary Myocardial enzyme within 48h after cardiac surgery No
Secondary Cystatin C within 48h after cardiac surgery No
Secondary High-sensitivity c-reactive protein(HS-CRP) within 48h after cardiac surgery No
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