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

C

Central South University

Status

Unknown

Conditions

Ischemic Reperfusion Injury
Rheumatic Disease of Heart Valve

Treatments

Device: Remote ischemic postconditioning

Study type

Interventional

Funder types

Other

Identifiers

NCT01476969
CentralSouthU

Details and patient eligibility

About

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

Full 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).

Enrollment

90 estimated patients

Sex

All

Ages

20 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Double Blind

90 participants in 1 patient group

Manual Tourniquet
Experimental group
Treatment:
Device: Remote ischemic postconditioning

Trial contacts and locations

1

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Central trial contact

Luo Wanjun, M.D.; Lv Hongwei, M.D.

Data sourced from clinicaltrials.gov

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