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Remote Ischemic Preconditioning for Contrast-Induced Acute Kidney Injury (RIP-CI-AKI Trial)

N/A
Recruiting
Research Sponsored by Salehin, Salman
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing an interventional or diagnostic radiological procedure in which they receive intravascular contrast, including patients undergoing coronary angiogram +/- percutaneous coronary intervention (PCI) for all clinical indications except those indicated for primary PCI due to STEMI
Patients presenting with a renal clearance in the range of less than 60 ml/min/1.73 m2 but not declared ESRD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patient's serum creatinine would be measured 48-72 hours after coronary angiogram, and re-measured 6 weeks after coronary angiogram.
Awards & highlights

RIP-CI-AKI Trial Summary

This trial will test the feasibility, safety, and effectiveness of remote ischemic preconditioning (RIPC) as a means of reducing the incidence of contrast-induced nephropathy (CI-AKI) in patients undergoing coronary angiography (CA) or other diagnostic contrast studies.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
RIPC is considered safe and has no reported adverse effects. It's a simple method where blood flow is temporarily stopped and then restored to an arm or leg which may help protect kidneys from damage during contrast imaging.

RIP-CI-AKI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having a procedure that involves dye in my veins, except for emergency heart artery opening.
Select...
My kidney function is low but I don't have end-stage renal disease.

RIP-CI-AKI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patient's serum creatinine would be measured 48-72 hours after coronary angiogram, and re-measured 6 weeks after coronary angiogram.
This trial's timeline: 3 weeks for screening, Varies for treatment, and patient's serum creatinine would be measured 48-72 hours after coronary angiogram, and re-measured 6 weeks after coronary angiogram. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Serum Creatinine
Secondary outcome measures
Major adverse events at 6 weeks, which would comprise death from all causes, including cardiovascular death, non-fatal infarction, hemofiltration or hemodialysis, and congestive heart failure leading to hospital admission.
Mortality within 6 weeks of contrast administration
Occurrence of re-hospitalization
+1 more

RIP-CI-AKI Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Remote Ischemic Preconditioning ProtocolExperimental Treatment1 Intervention
Group II: Sham Preconditioning ProtocolActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Salehin, SalmanLead Sponsor
The University of Texas Medical Branch, GalvestonLead Sponsor
240 Previous Clinical Trials
55,782 Total Patients Enrolled

Media Library

Remote Ischemic Preconditioning Clinical Trial Eligibility Overview. Trial Name: NCT05147831 — N/A
Acute Kidney Injury Research Study Groups: Remote Ischemic Preconditioning Protocol, Sham Preconditioning Protocol
Acute Kidney Injury Clinical Trial 2023: Remote Ischemic Preconditioning Highlights & Side Effects. Trial Name: NCT05147831 — N/A
Remote Ischemic Preconditioning 2023 Treatment Timeline for Medical Study. Trial Name: NCT05147831 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum number of participants currently approved for this trial?

"Confirmed. Per the clinicaltrials.gov website, this investigation is actively recruiting participants as of today. It was initially posted on November 30th 2021 with its most recent edit occurring April 14th 2022; 300 volunteers are needed at a single medical facility to complete the trial's goals."

Answered by AI

Does this investigation still accept new participants?

"As indicated on clinicaltrials.gov, this study is actively enlisting patients; the original posting was made on November 30th 2021 with a subsequent update released April 14th 2022."

Answered by AI
Recent research and studies
~37 spots leftby Jul 2024