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Vilon

KE, L-Lys-L-Glu, lysylglutamic acid

Quick Stats
Studies 40
Trials 100
Completed NA INTERVENTIONAL NCT03205410

Remote Ischemic Preconditioning as a New Method of Nephroprotection

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

Remote ischemic preconditioning (RIPC), elicited by brief episodes of ischemia and reperfusion in distant tissue, offers a protection against acute kidney injury (AKI) in patients after cardiac surgery. Investigators conducted a prospective, randomized, controlled clinical trial to assess whether RIPC reduces the incidence of AKI measured by standard way using serum creatinine concentration (SCr) and with use of serum level of neutrophil gelatinase-associated lipocalin (NGAL) as a new potential biomarker of a kidney injury. Moreover the aim of investigation was to analyse the safety and clinical outcomes of RIPC after elective, isolated, primary off-pump coronary artery bypass graft surgery (OPCAB).

Detailed Description

Cardiac surgery patients have a high risk of AKI. The development of AKI is associated with higher mortality and a higher risk for complications in patients undergoing cardiac surgery. However, there are no effective clinical strategies for preventing prevalence of AKI. RIPC as a simple, inexpensive way of protecting tissues against ischemic damage, may also reduce kidney injury. That makes RIPC under the area of interests of many researches which apply this method to prevent AKI. Investigators conducted a single-center, double-blind trial involving patients at high risk of postoperative AKI, in which want to check wether RIPC reduce the prevalence of AKI, according Kidney Disease: Improving Global Outcomes (KDIGO) definition, by increase in SCr. Furthermore researchers want to investigate a benefit from RIPC in reduction of level of SCr and higher glomerular filtration rate (GFR) 72 hours after off-pump coronary artery bypass as well as reduction of postoperative expression of NGAL an early biomarker of AKI.

Interventions

Name: remote ischemic preconditioning
Type: PROCEDURE
Description: The remote ischemic preconditioning protocol described before began after anesthesia induction, and was completed prior to the start of surgery.
Name: no - remote ischemic preconditioning
Type: PROCEDURE
Description: The sham - remote ischemic preconditioning protocol described before began after anesthesia induction, and was completed prior to the start of surgery.

Primary Outcomes

Measure: incidence of acute kidney injury within 72 hours after cardiac surgery
TimeFrame: 72 hours after cardiac surgery
Description: increase in serum creatinine level by more than 50% or more than 0.3mg/dL from baseline within 72 h after surgery
Measure: NGAL level
TimeFrame: 3 hours after cardiac surgery
Description: increased NGAL level within 3 hours after cardiac surgery

Trial Information

NCT ID

NCT03205410

Status

Completed

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Medical University of Lodz

Last Updated

December 15, 2025