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

Seoul National University

Status: Completed

Conditions: Renal Neoplasm; Renal Injury

Treatments: Procedure: Remote Ischemic Preconditioning; Procedure: Sham control

Study type: Interventional

Funder types: Other

Identifiers

NCT03273751

1707-087-870

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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86 participants in 2 patient groups

Remote Ischemic Preconditioning (RIPC)

Experimental group

Description:

Four cycles of upper arm ischemia/reperfusion

Treatment:

Procedure: Remote Ischemic Preconditioning

Sham control

Sham Comparator group

Description:

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

Treatment:

Procedure: Sham control