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Effect of Remote Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation

H

Huazhong University of Science and Technology

Status

Completed

Conditions

Kidney Failure
Kidney Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases

Treatments

Device: remote ischaemic preconditioning

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01289548
TJMZK201001

Details and patient eligibility

About

The purpose of this study was to investigate whether lower limb ischaemic preconditioning can improve renal function in patients undergoing living donor kidney transplantation

Full description

Ischemia reperfusion injury (IRI) induced renal failure after kidney transplantation is a common clinical problem associated with a high morbidity and mortality. To reduce the adverse effects of IRI after organ transplantation various strategies aimed at the different pathophysiological processes of IRI have been investigated. Remote ischemic preconditioning (RIPC) is one such strategy where brief IRI of one organ protects other organs from sustained IRI. Many studies have shown that RIPC protects heart, muscle flaps, stomach, liver, lungs, and kidneys from IRI. RIPC of the limb with a tourniquet is a safe and convenient method of preconditioning organs against IRI. However, the efficacy of RIPC in patients undergoing living donor kidney transplantation need to be established and mechanism of early and late RIPC, such as whether the donor should undergo remote preconditioning or the recipient, need to be investigated.

Enrollment

120 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject capable of giving written informed consent, with end-stage kidney disease, who is a suitable candidate for primary kidney transplantation
  • Living donors
  • Compatible ABO blood type
  • PRA < 20%

Exclusion criteria

  • Re-transplant patients
  • Those with peripheral vascular disease affecting the lower limbs

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 3 patient groups

control
No Intervention group
Description:
patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min
donor
Experimental group
Description:
Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
Treatment:
Device: remote ischaemic preconditioning
recipient
Experimental group
Description:
recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
Treatment:
Device: remote ischaemic preconditioning

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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