Effect of Remote Ischemic Perconditioning on Acute Kidney Injury in Adult Valve Replace
1 other identifier
interventional
90
1 country
1
Brief Summary
The purpose of this study is to determine whether Remote Ischemic Perconditioning is effective on Acute kidney injury in adult valve replacement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 16, 2011
CompletedFirst Posted
Study publicly available on registry
November 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedAugust 14, 2012
August 1, 2012
1.2 years
November 16, 2011
August 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Renal function
within the first 48h after cardiac surgery
Secondary Outcomes (4)
concentration of troponin I (cTnI)
within 48h after cardiac surgery
Myocardial enzyme
within 48h after cardiac surgery
Cystatin C
within 48h after cardiac surgery
High-sensitivity c-reactive protein(HS-CRP)
within 48h after cardiac surgery
Study Arms (1)
Manual Tourniquet
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- rheumatic heart valve disease requiring selective aortic or double valve(aortic and mitral valve) replacement
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Central South University
Changsha, Hunan, 410008, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Luo Wanjun, M.D.
Central South University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
November 16, 2011
First Posted
November 22, 2011
Study Start
September 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
August 14, 2012
Record last verified: 2012-08