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Completed

NCT Number: NCT01289548

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

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

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Key information

Conditions

Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Failure Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote ischaemic preconditioning

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.

Other names: RIPC

Primary outcomes

  1. Plasma Creatine Concentration of the Recipients

    Time frame: within the first 3days after the operation

    Plasma creatinine concentration before surgery, 1hour, 4hours, 24hours, 48hours and 72hours after the artery unclamping

  2. Urinary Output of the Recipients Postoperatively

    Time frame: within the first 3days after the operation

    Accumulated urinary output 1hour, 4hours and 24hours after the artery unclamping and the urinary output on the 2nd and 3rd day after the operation

  3. Plasma Concentration of NGAL in the Recipients

    Time frame: within the first 24hours after the operation

    Plasma concentration of neutrophil gelatinase-associated lipocalin (NGAL) before the operation and 24hours after the artery unclamping

Secondary outcomes

  1. Acute Rejection of Transplanted Kidney

    Time frame: before discharge

    biopsy-confirmed, clinically symptomatic

  2. Delayed Graft Function

    Time frame: before discharge

    Delayed Graft Function according to the clinical symptoms

  3. Length of Postoperative Hospital Stay

    Time frame: before discharge

    time from the day of operation to the day of discharge for the recipients

  4. Total Costs During the Hospitalization

    Time frame: from the admission to the discharge of the patients

    Total costs from the admission to the discharge of the recipients

  5. Urine Concentration of NAG Preoperatively in Recipients

    Time frame: before operation

    Urine concentration of N-acetyl-D-glucosaminidase (NAG) before the operation

  6. Urine Concentration of NAG Postoperatively in Recipients

    Time frame: within the first 24hours after the artery unclamping

    Urine concentration of N-acetyl-D-glucosaminidase (NAG) 1hour, 4hours and 24hours after the artery unclamping in the recipients

  7. Urine Concentration of RBP Preoperatively in the Recipients

    Time frame: before the operation

    Urine concentration of retinol binding protein (RBP) before the operation in the recipients

  8. Urine Concentration of RBP Postoperatively in the Recipients

    Time frame: within the first 24hours after the artery unclamping

    Urine concentration of retinol binding protein (RBP) 1hour, 4hours and 24hours after the artery unclamping in the recipients

  9. Plasma Concentration of SOD in the Recipients

    Time frame: within 24hours after the operation

    Plasma concentration of superoxide dismutase (SOD) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients

  10. Plasma Concentration of MDA in the Recipients

    Time frame: within the first 24hours after the operation

    Plasma concentration of malondialdehyde (MDA) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Collaborators

  • B. Braun Medical SA

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Feb 3, 2011
Registry last updated
Sep 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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