Urea for Chronic Hyponatremia

NCT04588207 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: STUDY20050035R21DK122023
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hyponatremia; Inappropriate ADH Syndrome

Keywords

Hyponatremia; SIADH; SIAD; Urea

Outcome Measures

Primary Outcomes (17)

• 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

• 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

• Monthly Enrollment Rate

  Number of participants enrolled in the study every month. To be assessed by analysis of enrollment data

  9 months

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (7)

• Number of Patients Screened

  9 months

• Number and Percentage of Patients Screened Who Met Inclusion/Exclusion Criteria for the Study

  9 months

• Number and Proportion of Participants Who Took More Than 80 Percent of Prescribed Urea Doses

  Baseline to day 42 while taking urea

• Number and Proportion of Participants Who Thought the Medication Was Acceptable

  Baseline to day 42 while taking urea

• Average Ratings for Medication Acceptability

  Baseline to day 42 while taking urea

Study Arms (2)

On Urea, Then Off Urea

EXPERIMENTAL

Participants assigned to this group will receive oral urea for 42 days (period 1), followed by a 10-day washout period, and then will be off urea for 42 days (period 2).

Drug: Urea

Off Urea, Then On Urea

EXPERIMENTAL

Participants assigned to this group will be off urea during for 42 days (period 1), followed by a 10-day washout period, and then on urea for 42 days (period 2)

Drug: Urea

Interventions

Urea DRUG

Groups "On Urea, Then Off Urea" and "Off Urea, Then On Urea" will receive urea during period 1 and period 2 of the study, respectively. The investigators will use the new American formulation of oral urea (i.e., Ure-Na™), which is packaged as a powder and mixed with 4 ounces. of water for oral consumption. Urea will be started at a dose of 15 grams of urea per mouth once daily. Dose titration will be based on the absolute increase in PNa on days 7 and 14. The urea dosing scheme will involve increasing from the starting dose of 15 grams/day to 30 grams/day (in 2 divided doses) based on the change in and absolute value of PNa, and subsequently, from 30 grams/day to 60 grams/day (in 2 divided doses) when indicated. The maximal dose of urea administered will be 60 g/day.

Also known as: Ure-Na

Off Urea, Then On Urea; On Urea, Then Off Urea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Hyponatremia with a PNa between 125 mmol/L and 132 mmol/L
• Plasma osmolality \< 275 mOsm/kg
• Clinical euvolemia
• Urine osmolality \> 100 mosm/kg
• Urine Na ≥ 20 mmol/L
• Intact adrenal function (i.e., morning plasma cortisol value ≥15 μg/dL, or negative corticotropin stimulation test)
• Normal thyroid stimulating hormone (TSH) level (i.e., TSH between 0.3 to 5 μIU/mL)
• eGFR \>= 45 ml/min/1.73 m2)

You may not qualify if:

• 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

Sponsors & Collaborators

• Helbert Rondon Berrios, MD, MS: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (41)

• Rondon-Berrios H, Berl T. Mild Chronic Hyponatremia in the Ambulatory Setting: Significance and Management. Clin J Am Soc Nephrol. 2015 Dec 7;10(12):2268-78. doi: 10.2215/CJN.00170115. Epub 2015 Jun 24.

  PMID: 26109207 BACKGROUND

• Schrier RW, Gross P, Gheorghiade M, Berl T, Verbalis JG, Czerwiec FS, Orlandi C; SALT Investigators. Tolvaptan, a selective oral vasopressin V2-receptor antagonist, for hyponatremia. N Engl J Med. 2006 Nov 16;355(20):2099-112. doi: 10.1056/NEJMoa065181. Epub 2006 Nov 14.

  PMID: 17105757 BACKGROUND

• Decaux G, Genette F. Urea for long-term treatment of syndrome of inappropriate secretion of antidiuretic hormone. Br Med J (Clin Res Ed). 1981 Oct 24;283(6299):1081-3. doi: 10.1136/bmj.283.6299.1081.

  PMID: 6794768 BACKGROUND

• Rondon-Berrios H, Tandukar S, Mor MK, Ray EC, Bender FH, Kleyman TR, Weisbord SD. Urea for the Treatment of Hyponatremia. Clin J Am Soc Nephrol. 2018 Nov 7;13(11):1627-1632. doi: 10.2215/CJN.04020318. Epub 2018 Sep 4.

  PMID: 30181129 BACKGROUND

• Gankam-Kengne F, Ayers C, Khera A, de Lemos J, Maalouf NM. Mild hyponatremia is associated with an increased risk of death in an ambulatory setting. Kidney Int. 2013 Apr;83(4):700-6. doi: 10.1038/ki.2012.459. Epub 2013 Jan 16.

  PMID: 23325088 BACKGROUND

• Boscoe A, Paramore C, Verbalis JG. Cost of illness of hyponatremia in the United States. Cost Eff Resour Alloc. 2006 May 31;4:10. doi: 10.1186/1478-7547-4-10.

  PMID: 16737547 BACKGROUND

• Decaux G. Is asymptomatic hyponatremia really asymptomatic? Am J Med. 2006 Jul;119(7 Suppl 1):S79-82. doi: 10.1016/j.amjmed.2006.05.013.

  PMID: 16843090 BACKGROUND

• Renneboog B, Musch W, Vandemergel X, Manto MU, Decaux G. Mild chronic hyponatremia is associated with falls, unsteadiness, and attention deficits. Am J Med. 2006 Jan;119(1):71.e1-8. doi: 10.1016/j.amjmed.2005.09.026.

  PMID: 16431193 BACKGROUND

• Verbalis JG, Barsony J, Sugimura Y, Tian Y, Adams DJ, Carter EA, Resnick HE. Hyponatremia-induced osteoporosis. J Bone Miner Res. 2010 Mar;25(3):554-63. doi: 10.1359/jbmr.090827.

  PMID: 19751154 BACKGROUND

• Kruse C, Eiken P, Vestergaard P. Hyponatremia and osteoporosis: insights from the Danish National Patient Registry. Osteoporos Int. 2015 Mar;26(3):1005-16. doi: 10.1007/s00198-014-2973-1. Epub 2014 Dec 3.

  PMID: 25466529 BACKGROUND

• Jamal SA, Arampatzis S, Harrison SL, Bucur RC, Ensrud K, Orwoll ES, Bauer DC. Hyponatremia and Fractures: Findings From the MrOS Study. J Bone Miner Res. 2015 Jun;30(6):970-5. doi: 10.1002/jbmr.2383.

  PMID: 25294595 BACKGROUND

• Hoorn EJ, Rivadeneira F, van Meurs JB, Ziere G, Stricker BH, Hofman A, Pols HA, Zietse R, Uitterlinden AG, Zillikens MC. Mild hyponatremia as a risk factor for fractures: the Rotterdam Study. J Bone Miner Res. 2011 Aug;26(8):1822-8. doi: 10.1002/jbmr.380.

  PMID: 21381111 BACKGROUND

• Mohan S, Gu S, Parikh A, Radhakrishnan J. Prevalence of hyponatremia and association with mortality: results from NHANES. Am J Med. 2013 Dec;126(12):1127-37.e1. doi: 10.1016/j.amjmed.2013.07.021.

  PMID: 24262726 BACKGROUND

• Greenberg A, Verbalis JG, Amin AN, Burst VR, Chiodo JA 3rd, Chiong JR, Dasta JF, Friend KE, Hauptman PJ, Peri A, Sigal SH. Current treatment practice and outcomes. Report of the hyponatremia registry. Kidney Int. 2015 Jul;88(1):167-77. doi: 10.1038/ki.2015.4. Epub 2015 Feb 11.

  PMID: 25671764 BACKGROUND

• Decaux G, Gankam Kengne F, Couturier B, Musch W, Soupart A, Vandergheynst F. Mild water restriction with or without urea for the longterm treatment of syndrome of inappropriate antidiuretic hormone secretion (SIADH): Can urine osmolality help the choice? Eur J Intern Med. 2018 Feb;48:89-93. doi: 10.1016/j.ejim.2017.09.024. Epub 2017 Oct 7.

  PMID: 29017746 BACKGROUND

• Decaux G. Treatment of the syndrome of inappropriate secretion of antidiuretic hormone by long loop diuretics. Nephron. 1983;35(2):82-8. doi: 10.1159/000183052. No abstract available.

  PMID: 6621759 BACKGROUND

• Decaux G, Waterlot Y, Genette F, Hallemans R, Demanet JC. Inappropriate secretion of antidiuretic hormone treated with frusemide. Br Med J (Clin Res Ed). 1982 Jul 10;285(6335):89-90. doi: 10.1136/bmj.285.6335.89.

  PMID: 6805839 BACKGROUND

• Decaux G, Waterlot Y, Genette F, Mockel J. Treatment of the syndrome of inappropriate secretion of antidiuretic hormone with furosemide. N Engl J Med. 1981 Feb 5;304(6):329-30. doi: 10.1056/NEJM198102053040605. No abstract available.

  PMID: 7442772 BACKGROUND

• Bhandari S, Peri A, Cranston I, McCool R, Shaw A, Glanville J, Petrakova L, O'Reilly K. A systematic review of known interventions for the treatment of chronic nonhypovolaemic hypotonic hyponatraemia and a meta-analysis of the vaptans. Clin Endocrinol (Oxf). 2017 Jun;86(6):761-771. doi: 10.1111/cen.13315. Epub 2017 Mar 27.

  PMID: 28214374 BACKGROUND

• Jaber BL, Almarzouqi L, Borgi L, Seabra VF, Balk EM, Madias NE. Short-term efficacy and safety of vasopressin receptor antagonists for treatment of hyponatremia. Am J Med. 2011 Oct;124(10):977.e1-9. doi: 10.1016/j.amjmed.2011.04.028.

  PMID: 21962320 BACKGROUND

• Li B, Fang D, Qian C, Feng H, Wang Y. The Efficacy and Safety of Tolvaptan in Patients with Hyponatremia: A Meta-Analysis of Randomized Controlled Trials. Clin Drug Investig. 2017 Apr;37(4):327-342. doi: 10.1007/s40261-016-0470-3.

  PMID: 27766511 BACKGROUND

• Rozen-Zvi B, Yahav D, Gheorghiade M, Korzets A, Leibovici L, Gafter U. Vasopressin receptor antagonists for the treatment of hyponatremia: systematic review and meta-analysis. Am J Kidney Dis. 2010 Aug;56(2):325-37. doi: 10.1053/j.ajkd.2010.01.013. Epub 2010 Jun 9.

  PMID: 20538391 BACKGROUND

• Zhang X, Zhao M, Du W, Zu D, Sun Y, Xiang R, Yang J. Efficacy and Safety of Vasopressin Receptor Antagonists for Euvolemic or Hypervolemic Hyponatremia: A Meta-Analysis. Medicine (Baltimore). 2016 Apr;95(15):e3310. doi: 10.1097/MD.0000000000003310.

  PMID: 27082573 BACKGROUND

• Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Grantham JJ, Higashihara E, Perrone RD, Krasa HB, Ouyang J, Czerwiec FS; TEMPO 3:4 Trial Investigators. Tolvaptan in patients with autosomal dominant polycystic kidney disease. N Engl J Med. 2012 Dec 20;367(25):2407-18. doi: 10.1056/NEJMoa1205511. Epub 2012 Nov 3.

  PMID: 23121377 BACKGROUND

• Spasovski G, Vanholder R, Allolio B, Annane D, Ball S, Bichet D, Decaux G, Fenske W, Hoorn EJ, Ichai C, Joannidis M, Soupart A, Zietse R, Haller M, van der Veer S, Van Biesen W, Nagler E; Hyponatraemia Guideline Development Group. Clinical practice guideline on diagnosis and treatment of hyponatraemia. Nephrol Dial Transplant. 2014 Apr;29 Suppl 2:i1-i39. doi: 10.1093/ndt/gfu040. Epub 2014 Feb 25.

  PMID: 24569496 BACKGROUND

• Decaux G, Andres C, Gankam Kengne F, Soupart A. Treatment of euvolemic hyponatremia in the intensive care unit by urea. Crit Care. 2010;14(5):R184. doi: 10.1186/cc9292. Epub 2010 Oct 14.

  PMID: 20946646 BACKGROUND

• Lockett J, Berkman KE, Dimeski G, Russell AW, Inder WJ. Urea treatment in fluid restriction-refractory hyponatraemia. Clin Endocrinol (Oxf). 2019 Apr;90(4):630-636. doi: 10.1111/cen.13930. Epub 2019 Jan 25.

  PMID: 30614552 BACKGROUND

• Nervo A, D'Angelo V, Rosso D, Castellana E, Cattel F, Arvat E, Grossi E. Urea in cancer patients with chronic SIAD-induced hyponatremia: Old drug, new evidence. Clin Endocrinol (Oxf). 2019 Jun;90(6):842-848. doi: 10.1111/cen.13966. Epub 2019 Mar 29.

  PMID: 30868608 BACKGROUND

• Soupart A, Coffernils M, Couturier B, Gankam-Kengne F, Decaux G. Efficacy and tolerance of urea compared with vaptans for long-term treatment of patients with SIADH. Clin J Am Soc Nephrol. 2012 May;7(5):742-7. doi: 10.2215/CJN.06990711. Epub 2012 Mar 8.

  PMID: 22403276 BACKGROUND

• Corona G, Giuliani C, Verbalis JG, Forti G, Maggi M, Peri A. Hyponatremia improvement is associated with a reduced risk of mortality: evidence from a meta-analysis. PLoS One. 2015 Apr 23;10(4):e0124105. doi: 10.1371/journal.pone.0124105. eCollection 2015.

  PMID: 25905459 BACKGROUND

• Vandergheynst F, Gombeir Y, Bellante F, Perrotta G, Remiche G, Melot C, Mavroudakis N, Decaux G. Impact of hyponatremia on nerve conduction and muscle strength. Eur J Clin Invest. 2016 Apr;46(4):328-33. doi: 10.1111/eci.12597. Epub 2016 Feb 23.

  PMID: 26835607 BACKGROUND

• Refardt J, Kling B, Krausert K, Fassnacht M, von Felten S, Christ-Crain M, Fenske W. Impact of chronic hyponatremia on neurocognitive and neuromuscular function. Eur J Clin Invest. 2018 Nov;48(11):e13022. doi: 10.1111/eci.13022. Epub 2018 Sep 19.

  PMID: 30153330 BACKGROUND

• Verbalis JG, Greenberg A, Burst V, Haymann JP, Johannsson G, Peri A, Poch E, Chiodo JA 3rd, Dave J. Diagnosing and Treating the Syndrome of Inappropriate Antidiuretic Hormone Secretion. Am J Med. 2016 May;129(5):537.e9-537.e23. doi: 10.1016/j.amjmed.2015.11.005. Epub 2015 Nov 14.

  PMID: 26584969 BACKGROUND

• Connaboy C, Johnson CD, LaGoy AD, Pepping GJ, Simpson RJ, Deng Z, Ma L, Bower JL, Eagle SR, Flanagan SD, Alfano CA. Intersession Reliability and Within-Session Stability of a Novel Perception-Action Coupling Task. Aerosp Med Hum Perform. 2019 Feb 1;90(2):77-83. doi: 10.3357/AMHP.5190.2019.

  PMID: 30670116 BACKGROUND

• Erickson GB, Citek K, Cove M, Wilczek J, Linster C, Bjarnason B, Langemo N. Reliability of a computer-based system for measuring visual performance skills. Optometry. 2011 Sep;82(9):528-42. doi: 10.1016/j.optm.2011.01.012. Epub 2011 Jun 25.

  PMID: 21705283 BACKGROUND

• Wang L, Krasich K, Bel-Bahar T, Hughes L, Mitroff SR, Appelbaum LG. Mapping the structure of perceptual and visual-motor abilities in healthy young adults. Acta Psychol (Amst). 2015 May;157:74-84. doi: 10.1016/j.actpsy.2015.02.005. Epub 2015 Mar 5.

  PMID: 25747573 BACKGROUND

• Borg FG, Laxaback G. Entropy of balance--some recent results. J Neuroeng Rehabil. 2010 Jul 30;7:38. doi: 10.1186/1743-0003-7-38.

  PMID: 20670457 BACKGROUND

• Kang HG, Costa MD, Priplata AA, Starobinets OV, Goldberger AL, Peng CK, Kiely DK, Cupples LA, Lipsitz LA. Frailty and the degradation of complex balance dynamics during a dual-task protocol. J Gerontol A Biol Sci Med Sci. 2009 Dec;64(12):1304-11. doi: 10.1093/gerona/glp113. Epub 2009 Aug 13.

  PMID: 19679739 BACKGROUND

• Vereeck L, Wuyts F, Truijen S, Van de Heyning P. Clinical assessment of balance: normative data, and gender and age effects. Int J Audiol. 2008 Feb;47(2):67-75. doi: 10.1080/14992020701689688.

  PMID: 18236239 BACKGROUND

• Wallmann HW. Comparison of elderly nonfallers and fallers on performance measures of functional reach, sensory organization, and limits of stability. J Gerontol A Biol Sci Med Sci. 2001 Sep;56(9):M580-3. doi: 10.1093/gerona/56.9.m580.

  PMID: 11524452 BACKGROUND

• Sterns RH, Silver SM, Hix JK. Urea for hyponatremia? Kidney Int. 2015 Feb;87(2):268-70. doi: 10.1038/ki.2014.320.

  PMID: 25635717 BACKGROUND

Related Links

• FDA Drug Safety Communication: FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death

MeSH Terms

Conditions

Hyponatremia; Inappropriate ADH Syndrome

Interventions

Urea

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals

Limitations and Caveats

Study was terminated because of inability to recruit. Only two participants were recruited of the estimated 30 participants.

Results Point of Contact

• Title: Dr. Helbert Rondon Berrios, Professor of Medicine
• Organization: University of Pittsburgh School of Medicine

rondonberriosh@upmc.edu

4126473120

Study Officials

• Helbert Rondon Berrios, MD. MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 19, 2020
• Study Start: December 28, 2021
• Primary Completion: September 29, 2022
• Study Completion: September 29, 2022
• Last Updated: May 20, 2024
• Results First Posted: May 20, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 12 months after publication of primary manuscript
• Access Criteria: Request in writing addressed to the principal investigator

Locations

US (1)