Remote Ischemic Preconditioning for Contrast-Induced Acute Kidney Injury
(RIP-CI-AKI Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Remote Ischemic Preconditioning for preventing contrast-induced acute kidney injury?
Is remote ischemic preconditioning safe for humans?
Remote ischemic preconditioning (RIPC) has been studied in several trials for its safety and effectiveness in preventing kidney injury caused by contrast dyes used in medical imaging. These studies, including randomized controlled trials and meta-analyses, generally suggest that RIPC is a safe procedure for humans.12356
How is the treatment Remote Ischemic Preconditioning different from other treatments for contrast-induced acute kidney injury?
Remote Ischemic Preconditioning (RIPC) is unique because it involves temporarily restricting blood flow to a limb to protect the kidneys from damage caused by contrast dyes used in medical imaging. This approach is different from other treatments as it uses the body's natural protective mechanisms rather than medications or direct interventions on the kidneys.25789
What is the purpose of this trial?
The use of imaging is increasing in clinical practice, either for diagnosis or intervention. In these imaging processes, contrast medium (CM) is widely used. However, CM administration can induce contrast-induced nephropathy (CI-AKI). CI-AKI is the third most common cause of renal insufficiency, and its incidence varies from 2% to 50% depending on patient risk factors; in addition, studies have shown that CI-AKI occurs in 2% to 25% of patients undergoing coronary intervention. CI-AKI is associated with significant mortality and morbidity in patients undergoing coronary angiography or other diagnostic contrast studies. We assessed the latest promising evidence on the ability of remote ischemic preconditioning (RIPC) to reduce the incidence of CI-AKI in patients undergoing Coronary Angiogram (CA) or diagnostic contrast studies such as CT angiogram, while at the same time being a non-invasive, low cost, easy, and safe method with absence of adverse effects. However, more randomized controlled trials are needed to confirm these preliminary results.The aim of this study is to minimize the incidence of CI-AKI at the University of Texas Medical Branch (UTMB). If found to be an effective method, RIPC would help minimize the incidence of CI-AKI in all institutions across the globe, who would adopt this intervention.The primary objective: i) reduce the rise in creatinine to \< 0.5 mg/dL post-CA in moderate to high risk patients and ii) reduce the incidence of renal replacement therapy post-CA in moderate to high risk patients; iii) we also aim to establish that RIPC is safe and effective.We hypothesize that the use of RIPC, when added to standard medical therapy (pre-and post-CA hydration), will mitigate the effects of contrast on the renal vasculature and lessen the incidence of CI-AKI in moderate to high risk patients at the University of Texas Medical Branch.The use of iodinated contrast to visually enhance target vasculature is a widely used diagnostic technique that is performed daily at UTMB, and around the world, for the diagnosis and management of a variety of conditions. A common complication of this procedure is acute kidney injury (AKI), generally referred to as contrast-induced nephropathy (CI-AKI). This complication can range from an isolated rise in serum creatinine to severe renal dysfunction necessitating renal replacement therapy. The incidence of CI-AKI has been reported as approximately 2-50%, depending upon the definition and sensitivity of assay employed to assess GFR in the hospital setting. In addition, CI-AKI is associated with significant mortality and morbidity. If proven to be beneficial, RIPC will bring about a reduction in incidence of CI-AKI, and thus help to reduce hospitalization and mortality from renal etiology following a given contrast procedure.
Eligibility Criteria
This trial is for adults with kidney function less than normal (renal clearance <60 ml/min/1.73 m2) who are about to undergo a radiological procedure using contrast, like a coronary angiogram. It's not for those under 18, without consent, very low blood pressure, certain heart conditions, on dialysis or with recent contrast exposure.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo Remote Ischemic Preconditioning (RIPC) or sham preconditioning prior to coronary angiogram
Follow-up
Participants are monitored for safety and effectiveness after treatment, with serum creatinine measured 48-72 hours and 6 weeks post-procedure
Treatment Details
Interventions
- Remote Ischemic Preconditioning
Find a Clinic Near You
Who Is Running the Clinical Trial?
Salehin, Salman
Lead Sponsor
The University of Texas Medical Branch, Galveston
Lead Sponsor