Remote Ischemic Preconditioning for Contrast-Induced Acute Kidney Injury

(RIP-CI-AKI Trial)

Overseen By Khaled Chatila, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Salehin, Salman

Disqualifiers: Dialysis, STEMI, Cardiogenic shock, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a method called Remote Ischemic Preconditioning (RIPC) to determine if it can prevent kidney problems after using contrast dye in medical imaging tests. Contrast dye, often used in procedures like coronary angiograms, can sometimes harm the kidneys, causing contrast-induced acute kidney injury (CI-AKI). The study aims to discover if RIPC, a simple and safe technique, can reduce these kidney issues. Suitable candidates for this trial are those undergoing imaging tests with contrast dye who have some kidney function concerns but are not on dialysis. The trial seeks to confirm that RIPC is effective and safe in reducing kidney-related complications after contrast procedures. As an unphased trial, it offers patients the opportunity to contribute to important research that could lead to safer imaging procedures.

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 prior data suggests that this remote ischemic preconditioning protocol is safe for reducing contrast-induced acute kidney injury?

Research has shown that remote ischemic preconditioning (RIPC) is a safe and well-tolerated procedure. It reduces the risk of kidney damage caused by contrast dye in patients with chronic kidney disease. Studies have found RIPC to be generally safe, with no major side effects reported. This method involves temporarily stopping blood flow to a limb, which appears to protect the kidneys during procedures using contrast dye. Evidence so far suggests that RIPC is a safe option for patients at risk of kidney injury from these dyes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Remote Ischemic Preconditioning (RIPC) is unique because it offers a non-invasive way to potentially protect the kidneys from damage caused by contrast agents used in imaging tests. Unlike traditional treatments that focus on managing symptoms after kidney injury occurs, RIPC aims to activate the body's own protective mechanisms before the damage happens, using brief episodes of controlled blood flow restriction to another part of the body. Researchers are excited about this approach because it could offer a proactive strategy to prevent kidney injury, reducing the need for interventions like hydration therapy or pharmaceutical agents after the fact.

What evidence suggests that remote ischemic preconditioning is effective for reducing contrast-induced acute kidney injury?

This trial will compare the effectiveness of Remote Ischemic Preconditioning (RIPC) with a Sham Preconditioning Protocol. Research has shown that RIPC can lower the risk of kidney damage from certain medical imaging tests. In one study, only 12% of participants who used RIPC experienced this kidney issue, compared to 40% in a group that did not use RIPC. Another study found that RIPC is easy to perform, safe, and effective for individuals with long-term kidney problems. However, some research suggests it might not be as effective for people with diabetes and existing kidney issues. Overall, RIPC appears promising for reducing the risk of kidney damage in certain patient groups. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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

I am having a procedure that involves dye in my veins, except for emergency heart artery opening.

Patients who are not yet recruited for other pharmacological or medical device clinical trials.

My kidney function is low but I don't have end-stage renal disease.

Exclusion Criteria

Your systolic blood pressure is less than 80 mmHg.

It will be hard for us to get information from you 6 weeks after the study starts.

I have had a procedure to block blood flow to my kidney.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Remote Ischemic Preconditioning (RIPC) or sham preconditioning prior to coronary angiogram

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with serum creatinine measured 48-72 hours and 6 weeks post-procedure

6 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Remote Ischemic Preconditioning

Trial Overview The study tests Remote Ischemic Preconditioning (RIPC), a non-invasive technique that might prevent kidney damage from contrast used in imaging procedures like coronary angiograms. The goal is to see if RIPC can reduce the risk of acute kidney injury when added to standard care.

How Is the Trial Designed?

Group I: Remote Ischemic Preconditioning Protocol Experimental Treatment 1 Intervention

Group II: Sham Preconditioning Protocol Active Control 1 Intervention

Who Is Running the Clinical Trial?

Salehin, Salman

Lead Sponsor

Trials

1

Recruited

300+

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8240924/

Remote Ischemic Preconditioning for Prevention of Contrast ... This study indicates that remote ischemic preconditioning is a simple and well-tolerated procedure, which reduces the incidence of CI-AKI in CKD 3 and 4 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772963X25005174

Remote Ischemic Preconditioning Prevents Acute Kidney ... Azizi, et al. Remote ischemic preconditioning to reduce contrast-induced acute kidney injury in chronic kidney disease: a randomized controlled trial. BMC ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05147831

Effectiveness of Remote Ischemic Preconditioning for ... We assessed the latest promising evidence on the ability of remote ischemic preconditioning (RIPC) to reduce the incidence of CI-AKI in patients undergoing ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0164256

Remote Ischemic Preconditioning for the Prevention of ... In this study, RIPC applied prior to elective PCI was not effective in preventing CI-AKI in patients with diabetes with pre-existing CKD. Trial Registration.

5. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.112.096370

Ischemic Preconditioning for Prevention of Contrast ... Contrast medium–induced acute kidney injury occurred in 26 patients (26%), 20 (40%) in the control group and 6 (12%) in the remote ischemic preconditioning ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07179874

Remote Ischemic Preconditioning to Prevent Contrast- ... This randomized trial aims to determine whether RIPC reduces oxidative kidney damage and improves renal outcomes in this high-risk population.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40067773/

Remote ischaemic pre-conditioning, kidney injury, and ... Remote ischaemic pre-conditioning (RIPC) delivered shortly prior to an angiographic procedure may reduce contrast-associated acute kidney injury (CA-AKI).