Sodium bicarbonate for Vascular Diseases

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of Colorado, Aurora, CO
Vascular Diseases+3 More
Sodium bicarbonate - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients

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Eligible Conditions

  • Vascular Diseases
  • Transplanted Kidney Complication
  • Metabolic Acidosis

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Sodium bicarbonate will improve 1 primary outcome and 4 secondary outcomes in patients with Vascular Diseases. Measurement will happen over the course of Baseline and 12 months..

Baseline and 12 months
Change in Brachial artery flow mediated dilation at 12 months
Change in Large elastic artery stiffness and compliance at 12 months
Change in Tubular atrophy at 12 months
Change in participant plasma and urine complement activation fragment levels at 12 months
Baseline and 12 months.
Change in interstitial fibrosis at 12 months

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Sodium bicarbonate
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 120 total participants across 2 different treatment groups

This trial involves 2 different treatments. Sodium Bicarbonate is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Sodium bicarbonate
Drug
Oral sodium bicarbonate at a dose of 0.5 mEq/kg-lean body weight/day
Placebo
Drug
Oral placebo at a dose of 0.5 mEq/kg-lean body weight/day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium bicarbonate
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline and 12 months for reporting.

Closest Location

University of Colorado - Aurora, CO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
If someone's BMI is less than 40 kg/m2, their FMD measurements may not be accurate show original
This is a statement about a person who can provide consent show original
The immunosuppression regimen at the University of Colorado consists of tacrolimus, mycophenolate mofetil and prednisone show original
A stable immunosuppression regimen means that the person's immune system is under control for at least three months before they are randomized into a study. show original
was an exclusion criterion People with a blood pressure of less than 130/80 mm Hg were not allowed to participate in the study. show original
The participants in the study were required to have a stable anti-hypertensive regimen for at least one month before they were randomized into one of the two groups. show original
This text is about the age range of 18 to 80 years. show original
Measurements of serum bicarbonate levels show that the patient has a range of 16-24 milliequivalents per liter. show original
Patient received a kidney transplant one year prior to the start of the study. show original
This text states that the estimated glomerular filtration rate (eGFR) is ≥ 45 ml/min/1.73m2 when estimated by the CKD-EPI equation. show original

Patient Q&A Section

What causes acidosis?

"Acute acidosis is most commonly caused by excessive gas in the stomach, a condition called gastropneumology, though it may also be caused by excess amounts of vomiting, or as a complication of liver disease. Clinically diagnosed anion gap acidosis is the initial state of a more complex picture involving acidosis and acidemia, usually caused by an acid accumulation in the lungs, called pulmonary acidosis." - Anonymous Online Contributor

Unverified Answer

How many people get acidosis a year in the United States?

"While one in four adults in the United States has some degree of acidosis, only 1.5% of children in the United States will be hospitalized and 1.4% (1.3% in adults and 0.1% in children) will die as a result of acidosis." - Anonymous Online Contributor

Unverified Answer

Can acidosis be cured?

"Acidosis is a dynamic condition that can be reversed by the administration of sodium bicarbonate. This may be achieved not only by the ingestion of NaHCO3 (sodium bicarbonate) but also by a variety of non-sodium bicarbonate supplements or dietary changes that increase HCO3 production, thus alleviating the acidosis. However, the clinical effect will vary among individuals in compliance with treatment and dosage." - Anonymous Online Contributor

Unverified Answer

What is acidosis?

"In summary, acidosis, commonly caused by diabetic ketoacidosis, is a metabolic disturbance in which one of many blood chemical variables is abnormal. It is not a disorder of the liver." - Anonymous Online Contributor

Unverified Answer

What are the signs of acidosis?

"Signs of acidosis include tachypnea (rapid breathing) and tachycardia (high heart rate). Often, patients with acute respiratory distress syndrome (ARDS) or chronic respiratory failure can exhibit these symptoms, leading to the misconception that patients with acute respiratory distress syndrome (ARDS) or chronic respiratory failure do not tolerate acidosis well. This misconception is often the result of prior research that failed to consider the fact that signs of respiratory distress may vary from patient to patient." - Anonymous Online Contributor

Unverified Answer

What are common treatments for acidosis?

"Acidosis is treated by supportive measures such as administering intravenous fluids, administering medication, and using proton-pump inhibitors to reduce acid build-up; these measures are necessary as a result of acidosis because they relieve pain and coughing, but do not affect progression directly. Patients with a worsening acidosis may benefit from administering sodium bicarbonate to prevent acidosis." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating acidosis?

"There was no evidence suggesting that specific treatments could improve on the current knowledge about acidosis. However, some recent findings on the brain may help us understand how we perceive acids. Understanding the neural circuits involved in the perception of acids might lead us to discover novel approaches to treat acidosis." - Anonymous Online Contributor

Unverified Answer

How does sodium bicarbonate work?

"There are four major points to keep in mind with sodium bicarbonate treatment; sodium bicarbonate prevents fluid loss by keeping pH and acid levels in check. Next, sodium bicarbonate reduces the overall costs by preventing the need to buy additional supplies or to add more dialysis to an already functioning machine. Finally, sodium bicarbonate can reduce the time taken to recover from the procedure by minimizing the need to recover from complications.\n answer: The data gathered by C. et al. proves that sodium bicarbonate has positive effects on the quality of patients' lives. There are a lot of advantages to using sodium bicarbonate like the aforementioned three." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving sodium bicarbonate?

"There have been six other clinical trials involving sodium bicarbonate treatment in patients with moderate to severe metabolic acidosis. Many of these trials are still ongoing and the findings are not yet complete. Overall, they demonstrate that sodium bicarbonate, when used in patients with metabolic acidosis, is safe and improves the symptoms of the condition." - Anonymous Online Contributor

Unverified Answer

What does sodium bicarbonate usually treat?

"There is a lack of evidence in terms of what constitutes a correct use of sodium bicarbonate in management of acid-base disturbances in patients. Further research is needed to identify appropriate indications for which sodium bicarbonate is effective in the treatment of acidosis and its sequelae." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of acidosis?

"Although acidosis is a complex clinical syndrome that affects the function of many internal organs, a very high proportion of patients have no identifiable cause. Of those who have a cause, acidosis is most commonly due to gastro-intestinal pathology which is the most common cause of chronic vomiting in the general population. Acidosis is often a result of an imbalance between the oral acid load and endogenous compensation mechanisms in the body. Hence, acidosis may be secondary to other conditions, but a strong likelihood of an identifiable cause exists." - Anonymous Online Contributor

Unverified Answer

Is sodium bicarbonate safe for people?

"Sodium bicarbinate does not seem to cause acute renal impairment in healthy volunteers. The risks of adverse reactions are considered to be less than 2.0%. Further studies are needed to validate these findings in people with renal impairment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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