AzTrials
AzTrials

Renal NeoplasmNCT03273751

The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy

A study testing Remote Ischemic Preconditioning in people with Renal Neoplasm and Renal Injury, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is intended to evaluate the renal protective effect of Remote Ischemic Preconditioning (RIPC) in patients undergoing partial nephrectomy. Half of the enrolled subjects will receive 4 cycles of brief ischemia on the upper arm after anesthesia induction and prior to the surgery, while the other half will not… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Renal Neoplasm, Renal Injury
What is being tested?
Remote Ischemic Preconditioning
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
1 siteSouth Korea
Study dates
1 Sep 2017to 28 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients scheduled to undergo open, laparoscopic, or robot-assisted laparoscopic partial nephrectomy
  • 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

Who cannot join

  • Peripheral vascular disease involving upper extremities or lower extremities
  • Severe cardiopulmonary diseases (valvular or ischemic heart disease, heart failure, chronic obstructive pulmonary disease)
  • Hepatic failure, renal failure

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

About this study

Official title: The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy : A Randomized Controlled Trial

This study is intended to evaluate the renal protective effect of Remote Ischemic Preconditioning (RIPC) in patients undergoing partial nephrectomy. Half of the enrolled subjects will receive 4 cycles of brief ischemia on the upper arm after anesthesia induction and prior to the surgery, while the other half will not receive this treatment as a control group.

Read the detailed description

Remote Ischemic Preconditioning (RIPC) is the concept of mitigating ischemia-reperfusion injury to target organs by a brief episode of ischemia-reperfusion of the limb. The protective effect of RIPC on major organs has been demonstrated in an animal study, but its clinical efficacy has not yet been established.

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.

Being tested
Remote Ischemic Preconditioning, Sham control
Keywords
Remote Ischemic Preconditioning, Partial nephrectomy, Acute kidney injury
Medical subject headings
Kidney Neoplasms, Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote Ischemic PreconditioningProcedure or surgery

    Also called RIPC

    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 controlProcedure or surgery

    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.

Study groups in NCT03273751
Study groupRoleWhat they receive
Remote Ischemic Preconditioning (RIPC)ExperimentalFour cycles of upper arm ischemia/reperfusion
Receives: Procedure: Remote Ischemic Preconditioning
Sham controlSham comparatorPlacement of a blood pressure cuff around upper arm without inflation.
Receives: Procedure: Sham control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum creatinine level

    Postoperative serum creatinine levels as an index of kidney damage

    Measured: Postoperative day 1

Secondary outcomes (23)

  1. The incidence of acute kidney injury (AKI)

    The incidence of AKI according to the serum creatinine diagnostic criteria of Kidney Disease Improving Global outcomes (KDIGO) Clinical Practice Guideline for AKI

    Measured: Within 7 days after surgery

  2. Serum creatinine level

    Postoperative serum creatinine levels as an index of kidney damage

    Measured: 1 hour after surgery

  3. Serum creatinine level

    Postoperative serum creatinine levels as an index of kidney damage

    Measured: Postoperative day 3

  4. Serum creatinine level

    Postoperative serum creatinine levels as an index of kidney damage

    Measured: 2 weeks after surgery

  5. estimated glomerular filtration rate (eGFR)

    eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).

    Measured: 1 hour after surgery

  6. estimated glomerular filtration rate (eGFR)

    eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).

    Measured: Postoperative day 1

  7. estimated glomerular filtration rate (eGFR)

    eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).

    Measured: Postoperative day 3

  8. estimated glomerular filtration rate (eGFR)

    eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).

    Measured: 2 weeks after surgery

  9. Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side

    Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.

    Measured: 5 min after the induction of anesthesia (baseline)

  10. Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side

    Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.

    Measured: 30 minutes after induction of anesthesia

  11. Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side

    Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.

    Measured: 60 minutes after induction of anesthesia

  12. Regional oxygen saturation (rSO2) of the contralateral kidney of the operated side

    Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.

    Measured: 90 minutes after induction of anesthesia

  13. Urine creatinine level

    Urine creatinine level

    Measured: Postoperative day 1

  14. Urine creatinine level

    Urine creatinine level

    Measured: 2 weeks after surgery

  15. Urine microalbumin

    Urine microalbumin

    Measured: Postoperative day 1

  16. Urine microalbumin

    Urine microalbumin

    Measured: 2 weeks after surgery

  17. Urine beta-2 microglobulin

    Urine beta-2 microglobulin

    Measured: Postoperative day 1

  18. Urine beta-2 microglobulin

    Urine beta-2 microglobulin

    Measured: 2 weeks after surgery

  19. Urine N-acetyl-beta-D-glucosaminidase

    Urine N-acetyl-beta-D-glucosaminidase

    Measured: Postoperative day 1

  20. Urine N-acetyl-beta-D-glucosaminidase

    Urine N-acetyl-beta-D-glucosaminidase

    Measured: 2 weeks after surgery

  21. Glomerular filtration rate measured by scintigraphy

    Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy

    Measured: preoperative baseline

  22. Glomerular filtration rate measured by scintigraphy

    Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy

    Measured: 6 months after surgery

  23. Glomerular filtration rate measured by scintigraphy

    Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy

    Measured: 12 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2017
  2. Study start1 Sep 2017
  3. Primary completion28 Aug 2018
  4. Study completion28 Aug 2018

Resources

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
Model description
A prospective, randomized, parallel group, controlled study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03273751
Sponsor's protocol ID
1707-087-870
Status last verified
Oct 2021
First submitted
3 Sep 2017
Last updated
21 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23452148

  • 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.

    PubMed 26024502

  • 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.

    PubMed 26936039

  • 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.

    PubMed 30180887

Questions about this trial

What is this clinical trial studying?

A study testing Remote Ischemic Preconditioning in people with Renal Neoplasm and Renal Injury, run by Seoul National University Hospital at 1 site in South Korea.

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 3 inclusion and 3 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 21 Oct 2021. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Serum creatinine level (time frame: Postoperative day 1). 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 NCT03273751, which also lists 4 linked publications.

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 21 Oct 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in