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Dialysate Sodium Concentration for Chronic Kidney Failure (SummerMRI Trial)
SummerMRI Trial Summary
This trial is investigating how inflammation and insulin resistance may cause protein energy wasting in dialysis patients.
SummerMRI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSummerMRI Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SummerMRI Trial Design
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Who is running the clinical trial?
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- I have not been hospitalized in the last month.I do not have any severe or unstable inflammatory diseases or active infections.You cannot tolerate the medication used in metabolic studies.My kidneys still work a bit or I produce over 400 ml of urine a day.I have Type 1 Diabetes and am on insulin therapy.You have metal inside your body that could cause problems during an MRI scan.My dialysis is working well and I have a good access point for it.I am currently taking steroids or other drugs that weaken my immune system.I have been on maintenance hemodialysis for over 6 months.
- Group 1: High Dialysate Na
- Group 2: Low Dialysate Na
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
How many test subjects are enrolled in this trial?
"Affirmative. Available on clinicaltrials.gov is data suggesting that this research trial, posted in March of 2022 and last updated April 7th of the same year, is still accepting participants for a cohort size of 20 individuals at 2 sites."
What is the ultimate purpose of this medical investigation?
"The principal evaluation of this experiment, which will last ~4 weeks, is the Net skeletal muscle protein balance measured by stable isotope technique expressed in g/100 ml/min. Other outcomes include Pulse Wave Velocity (measured via Sphygmocor), Recovery time (patient-reported) and Interleukin 6 as an inflammatory marker."
Does this experiment still have open enrollment?
"Clinicaltrials.gov currently displays that this research is actively recruiting participants having first been posted on March 1st 2022, and last adjusted on April 7th of the same year."
Is this experiment open to participants aged 65 or higher?
"This protocol outlines that individuals aged 21 to 80 are eligible for the trial. For those under 18, there exists 102 alternative studies and 885 additional ones available for people above 65 years of age."
Is it possible for me to partake in this clinical experiment?
"This experiment is accepting 20 individuals with kidney failure and advanced age, between 21 and 80. Vital criteria for consideration include: receiving maintenance haemodialysis for a period of 6 months or more; having dialysis adequacy (eKt/V > 1.2) over 3 consecutive months; possessing an operable AV access to support hemodialysis; and being able to provide informed consent."
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