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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Central South University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Luo Wanjun, Central South University
ClinicalTrials.gov Identifier:
NCT01476969
First received: November 16, 2011
Last updated: August 11, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention
Rheumatic Disease of Heart Valve
Ischemic Reperfusion Injury
Device: Remote ischemic postconditioning

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Remote Ischemic Perconditioning on Acute Kidney Injury in Adult Valve Replace

Further study details as provided by Central South University:

Primary Outcome Measures:
  • Renal function [ Time Frame: within the first 48h after cardiac surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • concentration of troponin I (cTnI) [ Time Frame: within 48h after cardiac surgery ] [ Designated as safety issue: No ]
  • Myocardial enzyme [ Time Frame: within 48h after cardiac surgery ] [ Designated as safety issue: No ]
  • Cystatin C [ Time Frame: within 48h after cardiac surgery ] [ Designated as safety issue: No ]
  • High-sensitivity c-reactive protein(HS-CRP) [ Time Frame: within 48h after cardiac surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: September 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Manual Tourniquet 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.
Other Name: Manual Tourniquet YZ-01

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).

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476969

Contacts
Contact: Luo Wanjun, M.D. 86-731-89753503 luo3478@yahoo.cn
Contact: Lv Hongwei, M.D. 86-13467616975 hongweilv@163.com

Locations
China, Hunan
Central South University Recruiting
Changsha, Hunan, China, 410008
Contact: Luo Wanjun, M.D.    86-731-89753503    luo3478@yahoo.cn   
Contact: Lv Hongwei, M.D.    86-13467616975    hongweilv@163.com   
Principal Investigator: Luo Wanjun, M.D.         
Sub-Investigator: Lv Hongwei, M.D.         
Sponsors and Collaborators
Central South University
Investigators
Study Director: Luo Wanjun, M.D. Central South University
  More Information

No publications provided

Responsible Party: Luo Wanjun, Director, Central South University
ClinicalTrials.gov Identifier: NCT01476969     History of Changes
Other Study ID Numbers: CentralSouthU
Study First Received: November 16, 2011
Last Updated: August 11, 2012
Health Authority: China: Ministry of Health

Keywords provided by Central South University:
Ischemia reperfusion injury
Cardiopulmonary bypass
Remote Ischemic Postconditioning
Other Functional Disturbances Following Cardiac Surgery

Additional relevant MeSH terms:
Acute Kidney Injury
Ischemia
Reperfusion Injury
Rheumatic Diseases
Cardiovascular Diseases
Connective Tissue Diseases
Kidney Diseases
Musculoskeletal Diseases
Pathologic Processes
Postoperative Complications
Renal Insufficiency
Urologic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014