Your session is about to expire
← Back to Search
Sodium Bicarbonate for Preventing Kidney Disease
Phase 2
Waitlist Available
Led By Donna S Sanders, DO
Research Sponsored by Norton Community Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stage III Chronic Kidney Disease (GFR 30-60ml/min per 1.73m2 calculated by using MDRD equation)
18+ years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will compare two different treatments for contrast induced nephropathy, a common kidney complication from certain medical procedures. One group will receive saline and the other sodium bicarbonate.
Who is the study for?
This trial is for adults over 18 with Stage III Chronic Kidney Disease who are scheduled for a CT scan using contrast at Norton Community Hospital. It's not for pregnant individuals, those with recent heart issues or uncontrolled hypertension, patients on dialysis, or anyone who has had certain treatments like pressor agents or exposure to contrast dye within the last 48 hours.Check my eligibility
What is being tested?
The study compares two methods to prevent kidney damage from contrast dye used in CT scans. Group A receives normal saline solution before and after the scan; Group B gets a sodium bicarbonate solution following similar timing. The main goal is to see which treatment better prevents an increase in serum creatinine levels.See study design
What are the potential side effects?
Potential side effects may include changes in urinary pH and volume overload, which can be indicated by altered vital signs such as blood pressure and oxygen saturation. Close monitoring will occur to manage these risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is moderately reduced.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Development of contrast-induced nephropathy, defined as an increase in serum creatinine of 25% or more within 2 day after administration of contrast
Secondary outcome measures
change in estimated glomerular filtration rate
change in mean arterial pressure after initial bolus, mmHg
change in serum bicarbonate
+6 moreFind a Location
Who is running the clinical trial?
Norton Community HospitalLead Sponsor
Mathew Cusano, MDStudy DirectorNorton Community Hospital
Donna S Sanders, DOPrincipal InvestigatorNorton Community Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a heart attack recently.My heart failure symptoms have recently gotten worse.I am currently on dialysis.I have been diagnosed with multiple myeloma.My kidney function is moderately reduced.Your blood pressure is not well controlled, with readings consistently above 160/100 mmHg despite treatment.I have been treated with specific medications like pressor agents or mannitol recently.I am 18 years old or older.Your creatinine level is higher than 8 mg/dL.I have not been exposed to contrast agents within 48 hours before the study.You are allergic to contrast dye.Your blood creatinine level has increased by at least 0.5mg/dL in the past 24 hours.
Research Study Groups:
This trial has the following groups: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this therapy secure enough to be used by individuals?
"This treatment's safety is estimated to be a 2 on the scale of 1-3, as it has only gone through Phase 2 trials. Thus far, there is evidence supporting its safety but none that can verify its efficacy."
Answered by AI
Is enrollment still accessible for this clinical trial?
"In accordance with information published on clinicaltrials.gov, this investigation is no longer recruiting subjects as of October 25th 2006. Although the project has been concluded, there are 480 other research studies accepting participants at present."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger