The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy
NCT ID: NCT03273751
Last Updated: 2021-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
86 participants
INTERVENTIONAL
2017-09-01
2018-08-28
Brief Summary
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Detailed Description
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The kidney is a typical organ vulnerable to ischemic injury, and the renal protective effect of RIPC can be expected. There have been many reports of renal protective effects of RIPC in cardiac and vascular surgery. On the other hand, few studies have investigated the effect of RIPC during partial nephrectomy in which ischemia-reperfusion injury can occur during the surgery.
In this study, the investigators will evaluate the effect of RIPC in patients undergoing partial nephrectomy to prevent renal impairment and improve the prognosis after the surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Remote Ischemic Preconditioning (RIPC)
Four cycles of upper arm ischemia/reperfusion
Remote Ischemic Preconditioning
After induction of anesthesia, RIPC consisted of four 5-min cycles of limb ischemia induced by a blood pressure cuff placed on the upper arm and inflated to 250 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated.
Sham control
Placement of a blood pressure cuff around upper arm without inflation.
Sham control
After induction of anesthesia, sham control consisted of the placement of a blood pressure cuff on the upper arm with no inflation during the surgery.
Interventions
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Remote Ischemic Preconditioning
After induction of anesthesia, RIPC consisted of four 5-min cycles of limb ischemia induced by a blood pressure cuff placed on the upper arm and inflated to 250 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated.
Sham control
After induction of anesthesia, sham control consisted of the placement of a blood pressure cuff on the upper arm with no inflation during the surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Normal contralateral renal function was defined as split renal function of \>40% as determined by preoperative Tc-99m DiethyleneTriamine Pentaacetic Acid (DTPA) kidney scan
* Written informed consent
Exclusion Criteria
* Severe cardiopulmonary diseases (valvular or ischemic heart disease, heart failure, chronic obstructive pulmonary disease)
* Hepatic failure, renal failure
20 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Won Ho Kim, MD
Clinical Associate Professor
Principal Investigators
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Won Ho Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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Huang J, Chen Y, Dong B, Kong W, Zhang J, Xue W, Liu D, Huang Y. Effect of remote ischaemic preconditioning on renal protection in patients undergoing laparoscopic partial nephrectomy: a 'blinded' randomised controlled trial. BJU Int. 2013 Jul;112(1):74-80. doi: 10.1111/bju.12004. Epub 2013 Mar 4.
Zarbock A, Schmidt C, Van Aken H, Wempe C, Martens S, Zahn PK, Wolf B, Goebel U, Schwer CI, Rosenberger P, Haeberle H, Gorlich D, Kellum JA, Meersch M; RenalRIPC Investigators. Effect of remote ischemic preconditioning on kidney injury among high-risk patients undergoing cardiac surgery: a randomized clinical trial. JAMA. 2015 Jun 2;313(21):2133-41. doi: 10.1001/jama.2015.4189.
Zhang L, Diao Y, Chen G, Tanaka A, Eastwood GM, Bellomo R. Remote ischemic conditioning for kidney protection: A meta-analysis. J Crit Care. 2016 Jun;33:224-32. doi: 10.1016/j.jcrc.2016.01.026. Epub 2016 Feb 10.
Hur M, Park SK, Shin J, Choi JY, Yoo S, Kim WH, Kim JT. The effect of remote ischemic preconditioning on serum creatinine in patients undergoing partial nephrectomy: a study protocol for a randomized controlled trial. Trials. 2018 Sep 4;19(1):473. doi: 10.1186/s13063-018-2820-3.
Other Identifiers
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1707-087-870
Identifier Type: -
Identifier Source: org_study_id