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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 presenting with a renal clearance in the range of less than 60 ml/min/1.73 m2 but not declared ESRD
Be older than 18 years old
Must not have
Impossibility to perform RIPC, caused by pathology in both arms (e.g. dystrophy, recent trauma, chronic wounds)
Percutaneous coiling/embolization procedures of the kidney
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
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is low but I don't have end-stage renal disease.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot have RIPC due to conditions in both arms.
Select...
I have had a procedure to block blood flow to my kidney.
Select...
I need medication through an IV for a severe heart condition.
Select...
I need an urgent heart artery exam due to a severe heart attack.
Select...
I am under 18 years old.
Select...
I am currently on dialysis.
Timeline
Screening ~ 3 weeks3 visits
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.
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.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Serum Creatinine
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
252 Previous Clinical Trials
56,586 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 am having a procedure that involves dye in my veins, except for emergency heart artery opening.I have had a procedure to block blood flow to my kidney.I need medication through an IV for a severe heart condition.You had a contrast dye injection in the past 30 days.You have Raynaud's disease.I need an urgent heart artery exam due to a severe heart attack.I am currently on dialysis.I cannot have RIPC due to conditions in both arms.I am under 18 years old.You have an intra-aortic balloon pump.My kidney function is low but I don't have end-stage renal disease.
Research Study Groups:
This trial has the following groups:- Group 1: Remote Ischemic Preconditioning Protocol
- Group 2: Sham Preconditioning Protocol
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.