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

Ischemic Reperfusion Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01476969
• Other study ID #: CentralSouthU
• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Ischemia
• Ischemic Reperfusion Injury
• Reperfusion Injury
• Rheumatic Disease of Heart Valve
• Rheumatic Diseases

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