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Dialysate Sodium Concentration for Chronic Kidney Failure (SummerMRI Trial)

N/A
Recruiting
Led By Talat A Ikizler, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have acceptable dialysis adequacy (eKt/V > 1.2) for a minimum of 3 months and a patent, well-functioning, hemodialysis AV access
On MHD for more than 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

SummerMRI Trial Summary

This trial is investigating how inflammation and insulin resistance may cause protein energy wasting in dialysis patients.

Who is the study for?
This trial is for individuals on hemodialysis for over 6 months, who can consent and have good dialysis adequacy. It's not suitable for those with recent hospitalization, significant residual kidney function or urine output, steroid or immunosuppressant use, pregnancy, intolerance to study medication, metal in body affecting MRI scans, Type 1 Diabetes on insulin therapy or severe inflammatory diseases.Check my eligibility
What is being tested?
The study investigates how different sodium levels in dialysate affect inflammation and insulin resistance in end-stage renal disease patients. Participants will be compared to controls without kidney disease by measuring tissue sodium content and markers of inflammation and protein metabolism.See study design
What are the potential side effects?
While the trial does not specify side effects directly related to low or high dialysate sodium concentration adjustments during hemodialysis, changes may impact blood pressure regulation and could potentially lead to muscle cramps or weakness.

SummerMRI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My dialysis is working well and I have a good access point for it.
Select...
I have been on maintenance hemodialysis for over 6 months.

SummerMRI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Muscle sodium content
Net skeletal muscle protein balance measured by stable isotope technique reported as g/100 ml/min
Muscle Tissue
+1 more
Secondary outcome measures
6-minute walk
Handgrip strength measured by dynamometer
Interleukin 1
+6 more

SummerMRI Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: High Dialysate NaExperimental Treatment1 Intervention
high dialysate sodium concentration (138 mEq/L)
Group II: Low Dialysate NaActive Control1 Intervention
Low dialysate sodium concentration (132 mEq/L)

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,605 Previous Clinical Trials
3,305,576 Total Patients Enrolled
Talat A Ikizler, MDPrincipal InvestigatorTennessee Valley Healthcare System Nashville Campus, Nashville, TN
4 Previous Clinical Trials
64 Total Patients Enrolled

Media Library

high dialysate sodium concentration (138 mEq/L) Clinical Trial Eligibility Overview. Trial Name: NCT04067752 — N/A
Kidney Disease Research Study Groups: High Dialysate Na, Low Dialysate Na
Kidney Disease Clinical Trial 2023: high dialysate sodium concentration (138 mEq/L) Highlights & Side Effects. Trial Name: NCT04067752 — N/A
high dialysate sodium concentration (138 mEq/L) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04067752 — N/A

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~0 spots leftby Apr 2024