Hyponatremia Clinical Trial
Official title:
Urea for Chronic Hyponatremia: A Pilot Study
Verified date | April 2024 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 and/or 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 and/or 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.
Status | Terminated |
Enrollment | 2 |
Est. completion date | September 29, 2022 |
Est. primary completion date | September 29, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age =18 years - Attended =1 visit at a University of Pittsburgh Medical Center (UPMC) outpatient clinic within the prior 12 months - Chronic hyponatremia with a history of = 2 sequential plasma sodium concentration (PNa) between 125 mmol/L and 132 mmol/L performed = 14 days apart within the last 12 months with most recent PNa = 132 mmol/L prior to screening - Patients are ambulatory without the need for any assist device (e.g., cane, walker) - Mini-mental state examination (MMSE) score = 25 - Diagnosis of SIADH established by the Bartter and Schwartz criteria as follows: 1. Hyponatremia with a PNa between 125 mmol/L and 132 mmol/L 2. Plasma osmolality < 275 mOsm/kg 3. Clinical euvolemia 4. Urine osmolality > 100 mosm/kg 5. Urine Na = 20 mmol/L 6. Intact adrenal function (i.e., morning plasma cortisol value =15 µg/dL, or negative corticotropin stimulation test) 7. Normal thyroid stimulating hormone (TSH) level (i.e., TSH between 0.3 to 5 µIU/mL) 8. eGFR >= 45 ml/min/1.73 m2) Exclusion Criteria: - Cirrhosis and/or end-stage liver disease - Heart failure on diuretics and/or with recorded left ventricular ejection fraction <40 percent - Chronic kidney disease with most recent estimated glomerular filtration rate <45 ml/min/1.73m2 - Adrenal insufficiency - Untreated hypothyroidism - Urinary tract obstruction within the prior 2 months - Uncontrolled hyperglycemia (most recent random plasma glucose = 200 mg/dL) - Ongoing drug treatment for hyponatremia with vaptans or combination of loop diuretics and salt tablets. - Active malignancy - Active infection - Neurological disorders with impairment of ambulation or cognition - End-stage lung disease with marked impairment in ambulatory capacity - Chronic pain with impairment of ambulation or cognition - Chronic nausea - Hypersensitivity to urea - Women who are pregnant, breast feeding, or of childbearing potential who are not using contraception - Patient is unable to consent for himself/herself |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Helbert Rondon Berrios, MD, MS | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
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* Note: There are 41 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number and Percentage of Participants Who Met Inclusion/Exclusion Criteria and Were Enrolled in the Study | Number and percentage of participants who met inclusion/exclusion criteria and were enrolled in the study. To be assessed by analysis of enrollment data. | 9 months | |
Primary | Number and Percentage of Participants Enrolled Who Completed the Study | Number and percentage of participants enrolled who completed the study. To be assessed by analysis of enrollment and completion data. | 9 months | |
Primary | Monthly Enrollment Rate | Number of participants enrolled in the study every month. To be assessed by analysis of enrollment data | 9 months | |
Primary | Number of Prescribed Urea Doses Taken by Participants | Number of prescribed urea doses taken by participants. To be assessed by records in study diary and number of returned medication doses. | Baseline to day 42 while taking urea | |
Primary | Reasons for Non-Adherence to Urea Therapy | Reasons for non-adherence to urea therapy. To be assessed by medication acceptability and medication side effect questionnaires | Baseline to day 42 while taking urea | |
Primary | Change in Plasma Sodium Concentration | Change in plasma sodium concentration from baseline to day 42. Based on plasma sodium assessments on days 0 and 42. | Baseline to day 42 | |
Primary | Change in Percentage Accuracy Action Boundary Selection | Change in percentage accuracy action boundary selection from baseline to day 42. This will be measured by the Perception-Action Coupling Task (PACT) which is an affordance-based assessment conducted on an iPad, which uses matched pairs of 'virtual' balls and 'virtual' holes to assess patients' ability to accurately assess their action boundaries. Accuracy of affordance perception is measured. Scores goes from 0% to 100% with higher score representing increased accuracy | Baseline to day 42 | |
Primary | Change in Overall Score of Sensorimotor Ability Battery | Change in overall score of sensorimotor ability battery from baseline to day 42. This will be measured by the Senaptec Sensory Station™ test battery which examines separate sensorimotor elements including; multiple object tracking, reaction time, perception span, go/no go, depth perception and dynamic visual acuity. Score goes from 0 to1500 with higher scores representing better sensorimotor ability | Baseline to day 42 | |
Primary | Change in the Sample Entropy of the Center of Pressure Data From the Force Plate | Measure the 'structure' of the noise in the oscillations of the center of mass of the individual. The measurement represent the percentage of displacement from the center of pressure. No reference ranges are available as these vary according to the population studied | Baseline to day 42 | |
Primary | Change in Percentage Angular Deviation of Vestibular Control System Using Dynamic Representation of Upright Stance | Change in percentage angular deviation of vestibular control system using dynamic representation of upright stance from baseline to day 42. This was assessed using the NeuroCom™ Sensory Organization. This test enables both the examination of postural control and stability in response to a direct perturbation of the vestibular control system underlying the maintenance of upright posture, giving insight into the relative contributions and/or any deficits in the vestibular system involved in maintaining upright stance in dynamic situations. No reference range for changes in percentage exist which vary with the population studied. Larger positive changes indicate significant improvement in vestibular balance control. | Baseline to day 42 | |
Primary | Change in Percentage Angular Deviation of Somatosensory Control System Using Dynamic Representation of Upright Stance | Change in percentage angular deviation of somatosensory control system using dynamic representation of upright stance from baseline to day 42. This will be assessed using the NeuroCom™ Sensory Organization. This test enables both the examination of postural control and stability in response to a direct perturbation of the somatosensory control system underlying the maintenance of upright posture, giving insight into the relative contributions and/or any deficits in the somatosensory system involved in maintaining upright stance in dynamic situations. No reference range for changes in percentage exist which vary with the population studied. Larger positive changes indicate significant improvement in somatosensory balance control. | Baseline to day 42 | |
Primary | Change in Percentage Angular Deviation of Visual Control System Using Dynamic Representation of Upright Stance | Change in percentage angular deviation of visual control system using dynamic representation of upright stance from baseline to day 42. This will be assessed using the NeuroCom™ Sensory Organization. This test enables both the examination of postural control and stability in response to a direct perturbation of the visual control system underlying the maintenance of upright posture, giving insight into the relative contributions and/or any deficits in the visual system involved in maintaining upright stance in dynamic situations. No reference range for changes in percentage exist which vary with the population studied. Larger positive changes indicate significant improvement in visual balance control. | Baseline to 42 days | |
Primary | Change in Percentage Weight Symmetry Using Dynamic Representation of Upright Stance | Change in percentage weight symmetry using dynamic representation of upright stance from baseline to day 42. This will be assessed using the Motor Control Test (MCT). MCT assesses the ability to quickly recover from an unexpected external translation. Weight symmetry indicates weight distribution under the left and right legs prior to perturbation onset. A score of 100 indicates perfect between-limb symmetry. Larger deviations away (higher or Lower) from 100 indicate asymmetry. Scores goes from -100 to +100 closer to 100 is optimal. | Baseline to day 42 | |
Primary | Change in Movement Latency of Posture Control and Stability Using Dynamic Representation of Upright Stance | Change in movement latency of posture control and stability using dynamic representation of upright stance from baseline to day 42. This will be assessed using the Motor Control Test (MCT). MCT assesses the ability to quickly recover from an unexpected external translation. Latency scores measure the time lapse between force plate translation on postural response for healthy, elderly populations, with previously reported mean latency values ranging from 126.80-131.40. Higher/Larger scores indicate poorer balance control. | Baseline to day 42 | |
Primary | Change in Amplitude Scaling of Posture Control and Stability Using Dynamic Representation of Upright Stance | Change in amplitude scaling of posture control and stability using dynamic representation of upright stance from baseline to day 42. This will be assessed using the Motor Control Test (MCT). MCT assesses the ability to quickly recover from an unexpected external translation. It is scored in units of angular momentum and normalized to body height and weight. No reference range for changes in percentage exist which vary with the population studied. Larger positive changes indicate significant improvement in ability to recover from an unexpected external translation reflecting better balance. | Baseline to day 42 | |
Primary | Number and Proportion of Participants Enrolled in the Study With Adverse Events Related to the Use of Urea | Number and proportion of participants enrolled in the study with adverse events related to the use of urea from baseline to day 42. To be assessed by medication side effect questionnaire. | Baseline to day 42 while taking urea | |
Primary | Adverse Events Related to Urea | To be assessed by medication side effect questionnaire. A tabulation of counts of participants experiencing specific known side effects of urea as well as their intensity (mild, moderate or severe) will be performed. | Baseline to day 42 while taking urea | |
Secondary | Number of Patients Screened | Number of patients screened. To be assessed by analysis of screening data. | 9 months | |
Secondary | Number and Percentage of Patients Screened Who Met Inclusion/Exclusion Criteria for the Study | Number and percentage of patients screened who met inclusion/exclusion criteria for the study.
To be assessed by analysis of screening and enrollment data. |
9 months | |
Secondary | Number and Proportion of Participants Who Took More Than 80 Percent of Prescribed Urea Doses | Number and proportion of participants who took more than 80 percent of prescribed urea doses. To be assessed by analysis of study diary and number of returned medication doses. | Baseline to day 42 while taking urea | |
Secondary | Number and Proportion of Participants Who Thought the Medication Was Acceptable | Number and proportion of participants who thought the medication was acceptable. Based on ratings for acceptability in the medication acceptability questionnaire. | Baseline to day 42 while taking urea | |
Secondary | Average Ratings for Medication Acceptability | Average ratings using a 5-point Likert scale medication acceptability questionnaire. in which responders specify their level of agreement to a statement in five points: (1) Strongly disagree; (2) Disagree; (3) Neutral; (4) Agree; (5) Strongly agree; or (1) Very Unhappy; (2) Unhappy; (3) Neutral; (4) Happy; (5) Very Happy. A higher overall score represents more acceptability | Baseline to day 42 while taking urea | |
Secondary | Change in SF-12 (Health Survey) Mental Component Summary (MCS) | Change in SF-12 (Health Survey) Mental Component Summary (MCS) from baseline to day 42. Based on SF-12 MCS assessments on days 0 and 42. This is computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Baseline to day 42 | |
Secondary | Change in SF-12 (Health Survey) Physical Component Summary (PCS) | Change in SF-12 (Health Survey) Physical Component Summary (PCS) from baseline to day 42. Based on SF-12 PCS assessments on days 0 and 42. This is computed using the scores of 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Baseline to day 42 |
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