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NCT Number: NCT03273751

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

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.

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Key information

Conditions

Renal Neoplasm Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Renal Injury Renal Insufficiency Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Remote ischemic preconditioning

Procedure

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.

Other names: RIPC

Sham Control

Procedure

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.

Primary outcomes

  1. Serum creatinine level

    Time frame: Postoperative day 1

    Postoperative serum creatinine levels as an index of kidney damage

Secondary outcomes

  1. The incidence of acute kidney injury (AKI)

    Time frame: Within 7 days after surgery

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

  2. Serum creatinine level

    Time frame: 1 hour after surgery

    Postoperative serum creatinine levels as an index of kidney damage

  3. Serum creatinine level

    Time frame: Postoperative day 3

    Postoperative serum creatinine levels as an index of kidney damage

  4. Serum creatinine level

    Time frame: 2 weeks after surgery

    Postoperative serum creatinine levels as an index of kidney damage

  5. estimated glomerular filtration rate (eGFR)

    Time frame: 1 hour after surgery

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

  6. estimated glomerular filtration rate (eGFR)

    Time frame: Postoperative day 1

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

  7. estimated glomerular filtration rate (eGFR)

    Time frame: Postoperative day 3

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

  8. estimated glomerular filtration rate (eGFR)

    Time frame: 2 weeks after surgery

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

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

    Time frame: 5 min after the induction of anesthesia (baseline)

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

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

    Time frame: 30 minutes after induction of anesthesia

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

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

    Time frame: 60 minutes after induction of anesthesia

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

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

    Time frame: 90 minutes after induction of anesthesia

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

  13. Urine creatinine level

    Time frame: Postoperative day 1

    Urine creatinine level

  14. Urine creatinine level

    Time frame: 2 weeks after surgery

    Urine creatinine level

  15. Urine microalbumin

    Time frame: Postoperative day 1

    Urine microalbumin

  16. Urine microalbumin

    Time frame: 2 weeks after surgery

    Urine microalbumin

  17. Urine beta-2 microglobulin

    Time frame: Postoperative day 1

    Urine beta-2 microglobulin

  18. Urine beta-2 microglobulin

    Time frame: 2 weeks after surgery

    Urine beta-2 microglobulin

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

    Time frame: Postoperative day 1

    Urine N-acetyl-beta-D-glucosaminidase

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

    Time frame: 2 weeks after surgery

    Urine N-acetyl-beta-D-glucosaminidase

  21. Glomerular filtration rate measured by scintigraphy

    Time frame: preoperative baseline

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

  22. Glomerular filtration rate measured by scintigraphy

    Time frame: 6 months after surgery

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

  23. Glomerular filtration rate measured by scintigraphy

    Time frame: 12 months after surgery

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 6, 2017
Registry last updated
Oct 21, 2021

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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