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

NCT03273751 | Completed

• 1 other identifier: 1707-087-870
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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 receive this treatment as a control group.

Conditions

Renal Neoplasm; Renal Injury

Keywords

Remote Ischemic Preconditioning; Partial nephrectomy; Acute kidney injury

Outcome Measures

Primary Outcomes (1)

• Serum creatinine level

  Postoperative serum creatinine levels as an index of kidney damage

  Postoperative day 1

Secondary Outcomes (23)

• The incidence of acute kidney injury (AKI)

  Within 7 days after surgery

• Serum creatinine level

  1 hour after surgery

• Serum creatinine level

  Postoperative day 3

• Serum creatinine level

  2 weeks after surgery

• estimated glomerular filtration rate (eGFR)

  1 hour after surgery

Study Arms (2)

Remote Ischemic Preconditioning (RIPC)

EXPERIMENTAL

Four cycles of upper arm ischemia/reperfusion

Procedure: Remote Ischemic Preconditioning

Sham control

SHAM COMPARATOR

Placement of a blood pressure cuff around upper arm without inflation.

Procedure: Sham control

Interventions

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.

Also known as: RIPC

Remote Ischemic Preconditioning (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.

Sham control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (4)

• 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.

  PMID: 23452148 BACKGROUND

• 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.

  PMID: 26024502 BACKGROUND

• 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.

  PMID: 26936039 BACKGROUND

• 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.

  PMID: 30180887 DERIVED

MeSH Terms

Conditions

Kidney Neoplasms; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Renal Insufficiency

Study Officials

• Won Ho Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators and outcome assessors will be blinded to group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: A prospective, randomized, parallel group, controlled study

Study Record Dates

• First Submitted: September 3, 2017
• First Posted: September 6, 2017
• Study Start: September 1, 2017
• Primary Completion: August 28, 2018
• Study Completion: August 28, 2018
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)