Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04588207
Status:
TERMINATED
Last Update Posted:
2024-05-20
First Post:
2020-10-07
Brief Title:
Urea for Chronic Hyponatremia
Sponsor:
Helbert Rondon Berrios MD MS
Organization:
University of Pittsburgh
Study Overview
Official Title:
Urea for Chronic Hyponatremia A Pilot Study
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit participants
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is examining how a dietary supplement called urea can be used to treat low blood sodium level Low blood sodium level is a common problem and some studies show that many patients with low blood sodium level suffer from brain fog andor loss of balance Unfortunately it is unknown at this point what the best treatment is for low blood sodium level With this pilot research study the investigators are hoping to learn more about whether urea is safe to take whether patients can tolerate taking urea for several weeks whether urea increases blood sodium level and whether urea can help prevent the brain fog andor loss of balance that some patients with low blood sodium level suffer from The information obtained with this study is intended to be used to design a larger study in the future to get a definite answer whether urea is beneficial for patients with low blood sodium level
Detailed Description:
Hyponatremia is the most common electrolyte disorder encountered clinically While acute andor severe hyponatremia is commonly associated with significant symptoms milder and more chronic forms of hyponatremia remain clinically inconspicuous as the brain effectively adapts to the low extracellular osmolality However recent evidence suggests that even mild hyponatremia is associated with subtle neurocognitive deficits gait disturbances falls fractures and osteoporosis as well as increased mortality Current therapeutic interventions for hyponatremia including fluid restriction and loop diuretics lack clinical trial data to support their efficacy and are commonly associated with poor adherence The discovery of vasopressin antagonists vaptans provided a new drug class targeting the most common mechanism of hyponatremia ie elevated vasopressin Despite the demonstrated efficacy of vaptans in clinical trials their use has been limited by high cost as well as safety concerns related to risk of liver injury and the potential for rapid correction of hyponatremia Thus despite the significant morbidity and mortality associated with chronic non-severe hyponatremia there is a paucity of definitively effective safe well-tolerated and reasonably priced treatments
Small European case series have suggested that oral urea is safe and effective for the treatment of hyponatremia However urea has not been available for the treatment of hyponatremia in the United States until very recently This research group recently published the first and only study describing the effectiveness and safety of a new American formulation of oral urea among hospitalized patients with hyponatremia However the latter was a retrospective study limited to hospitalized patients Data from large clinical trials on the efficacy of urea for the prevention of patient-centered outcomes in those with chronic hyponatremia are lacking The current proposal is a pilot study that seeks to establish the feasibility of recruiting ambulatory patients with chronic hyponatremia into a study of urea determine the acceptability of urea to patients and explore the effect of this agent on plasma sodium level PNa neurocognitive function and postural stability The investigators will recruit 30 ambulatory patients with chronic non-severe hyponatremia and randomize them to oral urea or no drug treatment for a period of 42 days Following this initial phase all participants will have a 10-day washout period followed by a 42-day period in which participants initially randomized to no drug therapy will receive urea and those initially treated with urea will receive no drug therapy The investigators will collect data regarding the ease of recruitment participant adherence to urea and adverse events related to its use The investigators will monitor participants PNa neurocognitive function and postural stability over the course of the study The feasibility acceptability and proof of conceptefficacy data from this pilot study will confirm the investigators capacity to conduct and will inform the design of a large clinical trial that will assess the efficacy of urea for the prevention of serious clinical outcomes of chronic non-severe hyponatremia
Small European case series have suggested that oral urea is safe and effective for the treatment of hyponatremia However urea has not been available for the treatment of hyponatremia in the United States until very recently This research group recently published the first and only study describing the effectiveness and safety of a new American formulation of oral urea among hospitalized patients with hyponatremia However the latter was a retrospective study limited to hospitalized patients Data from large clinical trials on the efficacy of urea for the prevention of patient-centered outcomes in those with chronic hyponatremia are lacking The current proposal is a pilot study that seeks to establish the feasibility of recruiting ambulatory patients with chronic hyponatremia into a study of urea determine the acceptability of urea to patients and explore the effect of this agent on plasma sodium level PNa neurocognitive function and postural stability The investigators will recruit 30 ambulatory patients with chronic non-severe hyponatremia and randomize them to oral urea or no drug treatment for a period of 42 days Following this initial phase all participants will have a 10-day washout period followed by a 42-day period in which participants initially randomized to no drug therapy will receive urea and those initially treated with urea will receive no drug therapy The investigators will collect data regarding the ease of recruitment participant adherence to urea and adverse events related to its use The investigators will monitor participants PNa neurocognitive function and postural stability over the course of the study The feasibility acceptability and proof of conceptefficacy data from this pilot study will confirm the investigators capacity to conduct and will inform the design of a large clinical trial that will assess the efficacy of urea for the prevention of serious clinical outcomes of chronic non-severe hyponatremia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21DK122023 | NIH | None | httpsreporternihgovquickSearchR21DK122023 |