Kidney DiseasesNCT01289548
Effect of Remote Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation
A study testing remote ischaemic preconditioning in people with Kidney Diseases and Kidney Failure, Chronic, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The purpose of this study was to investigate whether lower limb ischaemic preconditioning can improve renal function in patients undergoing living donor kidney transplantation Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Diseases, Kidney Failure, Chronic, Kidney Failure
- What is being tested?
- remote ischaemic preconditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- May 2010to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- Re-transplant patients
- Those with peripheral vascular disease affecting the lower limbs
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Effect of Lower Limb 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
Read the detailed 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.
- Conditions
- Kidney Diseases, Kidney Failure, Chronic, Kidney Failure, Renal Insufficiency, Renal Insufficiency, Chronic, Urologic Diseases
- Being tested
- remote ischaemic preconditioning
- Keywords
- remote ischaemic preconditioning, kidney transplantation
- Medical subject headings
- Kidney Diseases, Kidney Failure, Chronic, Renal Insufficiency, Renal Insufficiency, Chronic, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischaemic preconditioningDevice
Also called RIPC
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.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min |
| donor | Experimental | 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. Receives: Device: remote ischaemic preconditioning |
| recipient | Experimental | 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. Receives: Device: remote ischaemic preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Creatine Concentration of the Recipients
Plasma creatinine concentration before surgery, 1hour, 4hours, 24hours, 48hours and 72hours after the artery unclamping
Measured: within the first 3days after the operation
Urinary Output of the Recipients Postoperatively
Accumulated urinary output 1hour, 4hours and 24hours after the artery unclamping and the urinary output on the 2nd and 3rd day after the operation
Measured: within the first 3days after the operation
Plasma Concentration of NGAL in the Recipients
Plasma concentration of neutrophil gelatinase-associated lipocalin (NGAL) before the operation and 24hours after the artery unclamping
Measured: within the first 24hours after the operation
Secondary outcomes (10)
Acute Rejection of Transplanted Kidney
biopsy-confirmed, clinically symptomatic
Measured: before discharge
Delayed Graft Function
Delayed Graft Function according to the clinical symptoms
Measured: before discharge
Length of Postoperative Hospital Stay
time from the day of operation to the day of discharge for the recipients
Measured: before discharge
Total Costs During the Hospitalization
Total costs from the admission to the discharge of the recipients
Measured: from the admission to the discharge of the patients
Urine Concentration of NAG Preoperatively in Recipients
Urine concentration of N-acetyl-D-glucosaminidase (NAG) before the operation
Measured: before operation
Urine Concentration of NAG Postoperatively in Recipients
Urine concentration of N-acetyl-D-glucosaminidase (NAG) 1hour, 4hours and 24hours after the artery unclamping in the recipients
Measured: within the first 24hours after the artery unclamping
Urine Concentration of RBP Preoperatively in the Recipients
Urine concentration of retinol binding protein (RBP) before the operation in the recipients
Measured: before the operation
Urine Concentration of RBP Postoperatively in the Recipients
Urine concentration of retinol binding protein (RBP) 1hour, 4hours and 24hours after the artery unclamping in the recipients
Measured: within the first 24hours after the artery unclamping
Plasma Concentration of SOD in the Recipients
Plasma concentration of superoxide dismutase (SOD) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients
Measured: within 24hours after the operation
Plasma Concentration of MDA in the Recipients
Plasma concentration of malondialdehyde (MDA) before the operation, 1hour, 4hours and 24hours after the artery unclamping in the recipients
Measured: within the first 24hours after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2011 (estimated)
- Study startMay 2010
- Primary completionNov 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun Medical SA
- Responsible party
- Principal investigator, Hua Zheng, Huazhong University of Science and Technology
- Investigators
- Yuke Tian, M.D., Study chair, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289548
- Sponsor's protocol ID
- TJMZK201001
- Status last verified
- Sep 2012
- First submitted
- 2 Feb 2011
- Last updated
- 10 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23325011
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lower Limb Ischaemic Preconditioning on Renal Function in Patients Undergoing Living Donor Kidney Transplantation
- ClinicalTrials.gov ID
- NCT01289548
- Acronym / sponsor ID
- TJMZK201001
- Conditions
- Kidney Diseases, Kidney Failure, Chronic, Kidney Failure, Renal Insufficiency, Renal Insufficiency, Chronic, Urologic Diseases
- Keywords
- remote ischaemic preconditioning, kidney transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- B. Braun Medical SA
- Study start
- May 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 3 Feb 2011 (estimated)
- Results
- Posted 10 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min |
| donor | Experimental | Device: remote ischaemic preconditioningDonors 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. |
| recipient | Experimental | Device: remote ischaemic preconditioningrecipients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (2 listed)
- Re-transplant patients
- Those with peripheral vascular disease affecting the lower limbs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remote ischaemic preconditioningAlso: RIPCRemote 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. | Device | donor, recipient |
Primary outcome
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
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
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
10 secondary outcomes
Acute Rejection of Transplanted Kidney
Time frame: before discharge
Delayed Graft Function
Time frame: before discharge
Length of Postoperative Hospital Stay
Time frame: before discharge
Total Costs During the Hospitalization
Time frame: from the admission to the discharge of the patients
Urine Concentration of NAG Preoperatively in Recipients
Time frame: before operation
Urine Concentration of NAG Postoperatively in Recipients
Time frame: within the first 24hours after the artery unclamping
Urine Concentration of RBP Preoperatively in the Recipients
Time frame: before the operation
Urine Concentration of RBP Postoperatively in the Recipients
Time frame: within the first 24hours after the artery unclamping
Plasma Concentration of SOD in the Recipients
Time frame: within 24hours after the operation
Plasma Concentration of MDA in the Recipients
Time frame: within the first 24hours after the operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23325011Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuke Tian, M.D. study chair
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remote ischaemic preconditioning in people with Kidney Diseases and Kidney Failure, Chronic, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Creatine Concentration of the Recipients (time frame: within the first 3days after the operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01289548, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2013.