Trial · NCT04588207

Urea for Chronic Hyponatremia

NCT04588207, Phase 2, Terminated, Helbert Rondon Berrios, MD, MS; results first posted 2024-05-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Urea for Chronic Hyponatremia. Trials, record NCT04588207. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04588207

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Urea for Chronic Hyponatremia
NCT number: NCT04588207
Status: Terminated
Phases: Phase 2
Enrollment: 2 participants, actual
Lead sponsor: Helbert Rondon Berrios, MD, MS
Conditions: Hyponatremia, Inappropriate ADH Syndrome
Interventions: Urea
First posted: 2020-10-19
Last updated: 2024-05-20
Results first posted: 2024-05-20
Limitations and caveats: Study was terminated because of inability to recruit. Only two participants were recruited of the estimated 30 participants.

Source ClinicalTrials.gov

Registered outcomes24

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number and Percentage of Participants Who Met Inclusion/Exclusion Criteria and Were Enrolled in the Study	9 months	Number and percentage of participants who met inclusion/exclusion criteria and were enrolled in the study. To be assessed by analysis of enrollment data.
Primary	Number and Percentage of Participants Enrolled Who Completed the Study	9 months	Number and percentage of participants enrolled who completed the study. To be assessed by analysis of enrollment and completion data.
Primary	Monthly Enrollment Rate	9 months	Number of participants enrolled in the study every month. To be assessed by analysis of enrollment data
Primary	Number of Prescribed Urea Doses Taken by Participants	Baseline to day 42 while taking urea	Number of prescribed urea doses taken by participants. To be assessed by records in study diary and number of returned medication doses.
Primary	Reasons for Non-Adherence to Urea Therapy	Baseline to day 42 while taking urea	Reasons for non-adherence to urea therapy. To be assessed by medication acceptability and medication side effect questionnaires
Primary	Change in Plasma Sodium Concentration	Baseline to day 42	Change in plasma sodium concentration from baseline to day 42. Based on plasma sodium assessments on days 0 and 42.
Primary	Change in Percentage Accuracy Action Boundary Selection	Baseline to day 42	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
Primary	Change in Overall Score of Sensorimotor Ability Battery	Baseline to day 42	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
Primary	Change in the Sample Entropy of the Center of Pressure Data From the Force Plate	Baseline to day 42	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
Primary	Change in Percentage Angular Deviation of Vestibular Control System Using Dynamic Representation of Upright Stance	Baseline to day 42	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.

1 to 10 of 24Source ClinicalTrials.gov

See all 24 registered outcomes

Outcomes24

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number and Percentage of Participants Who Met Inclusion/Exclusion Criteria and Were Enrolled in the Study	9 months		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number and Percentage of Participants Enrolled Who Completed the Study	9 months		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Monthly Enrollment Rate	9 months		participants per month	MEAN
PRIMARY	Number of Prescribed Urea Doses Taken by Participants	Baseline to day 42 while taking urea	The measure is only applicable when on urea	15-g urea packets	MEAN
PRIMARY	Reasons for Non-Adherence to Urea Therapy	Baseline to day 42 while taking urea	The measure is only applicable when on urea	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Change in Plasma Sodium Concentration	Baseline to day 42	All participants who received at least one dose of each intervention and completed all study visits were included	mmol/L	MEAN
PRIMARY	Change in Percentage Accuracy Action Boundary Selection	Baseline to day 42	All participants who received at least one dose of each intervention and completed all study visits were included	percentage accuracy	MEAN
PRIMARY	Change in Overall Score of Sensorimotor Ability Battery	Baseline to day 42	All participants who received at least one dose of each intervention and completed all study visits were included	score on a scale	MEAN
PRIMARY	Change in the Sample Entropy of the Center of Pressure Data From the Force Plate	Baseline to day 42	All participants who received at least one dose of each intervention and completed all study visits were included	percentage change from baseline	MEAN
PRIMARY	Change in Percentage Angular Deviation of Vestibular Control System Using Dynamic Representation of Upright Stance	Baseline to day 42	All participants who received at least one dose of each intervention and completed all study visits were included	percentage	MEAN

1 to 10 of 24Source ClinicalTrials.gov

See all 24 outcomes

Results by group60

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number and Percentage of Participants Who Met Inclusion/Exclusion Criteria and Were Enrolled in the Study	Urea		2		Participants
Number and Percentage of Participants Who Met Inclusion/Exclusion Criteria and Were Enrolled in the Study	No Urea		2		Participants
Number and Percentage of Participants Enrolled Who Completed the Study	Urea		2		Participants
Number and Percentage of Participants Enrolled Who Completed the Study	No Urea		2		Participants
Monthly Enrollment Rate	Urea		0.07	Standard Deviation 0	participants per month
Monthly Enrollment Rate	No Urea		0.07	Standard Deviation 0	participants per month
Number of Prescribed Urea Doses Taken by Participants	Urea		61.5	Full Range 11 to 112	15-g urea packets
Reasons for Non-Adherence to Urea Therapy	Urea	Inconvenient medication dose frequency	2		Participants
Reasons for Non-Adherence to Urea Therapy	Urea	Inconvenient medication amount	1		Participants
Reasons for Non-Adherence to Urea Therapy	Urea	Medication is unsuitable to take outside home	2		Participants

1 to 10 of 60Source ClinicalTrials.gov

See all 60 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period 1	STARTED	On Urea, Then Off Urea	1
Period 1	STARTED	Off Urea, Then On Urea	1
Period 1	COMPLETED	On Urea, Then Off Urea	1
Period 1	COMPLETED	Off Urea, Then On Urea	1
Period 1	NOT COMPLETED	On Urea, Then Off Urea	0
Period 1	NOT COMPLETED	Off Urea, Then On Urea	0
Washout Period	STARTED	On Urea, Then Off Urea	1
Washout Period	STARTED	Off Urea, Then On Urea	1
Washout Period	COMPLETED	On Urea, Then Off Urea	1
Washout Period	COMPLETED	Off Urea, Then On Urea	1

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Nausea	Gastrointestinal disorders	Urea	1	2	4
other	Nausea	Gastrointestinal disorders	No Urea	0	2	0
other	Diarrhea	Gastrointestinal disorders	Urea	1	2	1
other	Diarrhea	Gastrointestinal disorders	No Urea	0	2	0
other	Headaches	Nervous system disorders	Urea	1	2	2
other	Headaches	Nervous system disorders	No Urea	0	2	0
other	Hyponatremia	Metabolism and nutrition disorders	Urea	1	2	1
other	Hyponatremia	Metabolism and nutrition disorders	No Urea	0	2	0
other	Hyperglycemia	Metabolism and nutrition disorders	Urea	1	2	3
other	Hyperglycemia	Metabolism and nutrition disorders	No Urea	1	2	2

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Urea	0	2
Total, all-cause mortality	No Urea	0	2
Total, other adverse events	Urea	2	2
Total, other adverse events	No Urea	1	2
Total, serious adverse events	Urea	0	2
Total, serious adverse events	No Urea	0	2

Source ClinicalTrials.gov

Papers41

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
6621759	BACKGROUND	PubMed
6794768	BACKGROUND	PubMed
6805839	BACKGROUND	PubMed
7442772	BACKGROUND	PubMed
11524452	BACKGROUND	PubMed
16431193	BACKGROUND	PubMed
16737547	BACKGROUND	PubMed
16843090	BACKGROUND	PubMed
17105757	BACKGROUND	PubMed
18236239	BACKGROUND	PubMed

1 to 10 of 41

See all 41 papers

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R21DK122023	Urea for chronic hyponatremia: a pilot study	RONDON BERRIOS, HELBERT; WEISBORD, STEVEN	UNIVERSITY OF PITTSBURGH AT PITTSBURGH	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2020 to 2021

Source NIH RePORTER

Trial comparisons6

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Urea vs No Urea: Number and Proportion of Participants Who Thought the Medication Was Acceptable	Trial comparisons
Urea vs No Urea: Number and Percentage of Participants Enrolled Who Completed the Study	Trial comparisons
Urea vs No Urea: Number and Percentage of Participants Who Met Inclusion/Exclusion Criteria and Were Enrolled in the Study	Trial comparisons
Urea vs No Urea: Number and Proportion of Participants Enrolled in the Study With Adverse Events Related to the Use of Urea	Trial comparisons
Urea vs No Urea: deaths from any cause	Trial comparisons
Urea vs No Urea: serious adverse events	Trial comparisons

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Go/No-Go Task	Primary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04588207

GET https://conductscience.org/api/trials/v1/NCT04588207/registered?page=2

API reference For AI assistants