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

NCT ID: NCT01289548

Last Updated: 2013-09-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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control

patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min

Group Type NO_INTERVENTION

No interventions assigned to this group

donor

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.

Group Type EXPERIMENTAL

remote ischaemic preconditioning

Intervention Type DEVICE

Remote ischaemic preconditioning consisted of three 5-min cycles of left lower limb ischaemia, which was induced by an automated cuff-inflator placed on the left lower limb and inflated to 300 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.

recipient

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.

Group Type EXPERIMENTAL

remote ischaemic preconditioning

Intervention Type DEVICE

Remote ischaemic preconditioning consisted of three 5-min cycles of left lower limb ischaemia, which was induced by an automated cuff-inflator placed on the left lower limb and inflated to 300 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.

Interventions

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remote ischaemic preconditioning

Remote ischaemic preconditioning consisted of three 5-min cycles of left lower limb ischaemia, which was induced by an automated cuff-inflator placed on the left lower limb and inflated to 300 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.

Intervention Type DEVICE

Other Intervention Names

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RIPC

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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B. Braun Medical SA

INDUSTRY

Sponsor Role collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Hua Zheng

M.D. Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuke Tian, M.D.

Role: STUDY_CHAIR

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Locations

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Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

Countries

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China

References

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Chen Y, Zheng H, Wang X, Zhou Z, Luo A, Tian Y. Remote ischemic preconditioning fails to improve early renal function of patients undergoing living-donor renal transplantation: a randomized controlled trial. Transplantation. 2013 Jan 27;95(2):e4-6. doi: 10.1097/TP.0b013e3182782f3a. No abstract available.

Reference Type DERIVED
PMID: 23325011 (View on PubMed)

Other Identifiers

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TJMZK201001

Identifier Type: -

Identifier Source: org_study_id

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