Trial · NCT04622709
Pilot Study of Loop Diuretics Among Individuals Receiving Hemodialysis
NCT04622709, Phase 2, Completed, University of North Carolina, Chapel Hill; results first posted 2022-06-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pilot Study of Loop Diuretics Among Individuals Receiving Hemodialysis. Trials, record NCT04622709. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04622709
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study of Loop Diuretics Among Individuals Receiving Hemodialysis
- NCT number
- NCT04622709
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 39 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Chronic Kidney Disease Requiring Chronic Dialysis
- Interventions
- Furosemide (loop diuretic) Tablets
- First posted
- 2020-11-10
- Last updated
- 2022-06-13
- Results first posted
- 2022-06-13
Source ClinicalTrials.gov
Registered outcomes214
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 5 | Baseline and study week 5 (5 weeks after study medication start | Participants will follow standard dialysis clinic protocols for 24-urine volume collection. Classifying participants as has having an increase in 24-hour urine volume will be contingent on the amount of urine the participant makes at baseline. * Among participants with baseline 24-hour urine volume ≥200 mL: ≥25% increase in urine volume is considered an increase. * Among participants with baseline 24-hour urine volume \<200 mL: ≥50 mL increase in urine volume to a urine volume of at least 100 mL/24-hours is considered an increase. The percentage of participants who have a defined increase in 24-urine volume from baseline to week 5 will be determined. |
| Primary | Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 12 | Baseline and study week 12 (12 weeks after study medication start) | Participants will follow standard dialysis clinic protocols for 24-urine volume collection. Classifying participants as has having an increase in 24-hour urine volume will be contingent on the amount of urine the participant makes at baseline. * Among participants with baseline 24-hour urine volume ≥200 mL: ≥25% increase in urine volume is considered an increase. * Among participants with baseline 24-hour urine volume \<200 mL: ≥50 mL increase in urine volume to a urine volume of at least 100 mL/24-hours is considered an increase. The percentage of participants who have a defined increase in 24-urine volume from baseline to week 12 will be determined. |
| Primary | Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 18 | Baseline and study week 18 (18 weeks after study medication start) | Participants will follow standard dialysis clinic protocols for 24-urine volume collection. Classifying participants as has having an increase in 24-hour urine volume will be contingent on the amount of urine the participant makes at baseline. * Among participants with baseline 24-hour urine volume ≥200 mL: ≥25% increase in urine volume is considered an increase. * Among participants with baseline 24-hour urine volume \<200 mL: ≥50 mL increase in urine volume to a urine volume of at least 100 mL/24-hours is considered an increase. The percentage of participants who have a defined increase in 24-urine volume from baseline to week 18 will be determined. |
| Primary | Percentage of Participants With A Serum Potassium <3.2 mEq/L at Week 1 | Study week 1 (1 week after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 1 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 2 | Study week 2 (2 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 2 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 3 | Study week 3 (3 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 3 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 4 | Study week 4 (4 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 4 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 5 | Study week 5 (5 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 5 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 6 | Study week 6 (6 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 6 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined. |
| Primary | Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 9 | Study week 9 (9 weeks after study medication start) | Blood samples will be collected from participants prior to their dialysis treatments at the week 9 study visit. The percentage of participants who have a serum potassium \<3.2 mEq/L will be determined. |
1 to 10 of 214Source ClinicalTrials.gov
See all 214 registered outcomesOutcomes214
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 5 | Baseline and study week 5 (5 weeks after study medication start | Summarizing outcome events as a single arm (i.e., patients with a baseline 24-hour urine volume ≥200 mL and \< 200 mL as a single group) was pre-specified in the protocol. 36 participants completed the week 5 24-hour urine volume collection. Thus, the analysis population is 36 participants. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 12 | Baseline and study week 12 (12 weeks after study medication start) | Summarizing outcome events as a single arm (i.e., patients with a baseline 24-hour urine volume ≥200 mL and \< 200 mL as a single group) was pre-specified in the protocol. 33 participants completed the week 12 24-hour urine volume collection. Thus, the analysis population is 33 participants. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 18 | Baseline and study week 18 (18 weeks after study medication start) | Summarizing outcome events as a single arm (i.e., patients with a baseline 24-hour urine volume ≥200 mL and \< 200 mL as a single group) was pre-specified in the protocol. Out of the 33 participants still enrolled in the study at week 18, 32 completed the week 18 24-hour urine volume collection. Thus, the analysis population is 32 participants. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With A Serum Potassium <3.2 mEq/L at Week 1 | Study week 1 (1 week after study medication start) | 38 participants completed the week 1 blood collection. Thus, the analysis population is 38 participants. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 2 | Study week 2 (2 weeks after study medication start) | 37 participants completed the week 2 blood collection. Thus, the analysis population is 37 participants. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 3 | Study week 3 (3 weeks after study medication start) | 37 participants completed the week 3 blood collection. Thus, the analysis population is 37 participants. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 4 | Study week 4 (4 weeks after study medication start) | 37 participants completed the week 4 blood collection. Thus, the analysis population is 37 participants. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 5 | Study week 5 (5 weeks after study medication start) | 36 participants completed the week 5 blood collection. Thus, the analysis population is 36 participants. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 6 | Study week 6 (6 weeks after study medication start) | 36 participants completed the week 6 blood collection. Thus, the analysis population is 36 participants. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 9 | Study week 9 (9 weeks after study medication start) | 36 participants completed the week 9 blood collection. Thus, the analysis population is 36 participants. | Percentage of participants | NUMBER |
1 to 10 of 214Source ClinicalTrials.gov
See all 214 outcomesResults by group208
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 5 | Study Drug Administration: Furosemide | 33 | percentage of participants | ||
| Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 12 | Study Drug Administration: Furosemide | 33 | Percentage of participants | ||
| Percentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 18 | Study Drug Administration: Furosemide | 22 | Percentage of participants | ||
| Percentage of Participants With A Serum Potassium <3.2 mEq/L at Week 1 | Study Drug Administration: Furosemide | 0 | percentage of participants | ||
| Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 2 | Study Drug Administration: Furosemide | 0 | Percentage of participants | ||
| Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 3 | Study Drug Administration: Furosemide | 0 | Percentage of participants | ||
| Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 4 | Study Drug Administration: Furosemide | 0 | Percentage of participants | ||
| Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 5 | Study Drug Administration: Furosemide | 0 | Percentage of participants | ||
| Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 6 | Study Drug Administration: Furosemide | 0 | Percentage of participants | ||
| Percentage of Participants With a Serum Potassium <3.2 mEq/L at Week 9 | Study Drug Administration: Furosemide | 0 | Percentage of participants |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (First 6 Weeks) | STARTED | Study Drug Administration: Furosemide | 39 | |
| Period 1 (First 6 Weeks) | COMPLETED | Study Drug Administration: Furosemide | 36 | |
| Period 1 (First 6 Weeks) | NOT COMPLETED | Study Drug Administration: Furosemide | 3 | |
| Period 2 (Subsequent 12 Weeks) | STARTED | Study Drug Administration: Furosemide | 36 | |
| Period 2 (Subsequent 12 Weeks) | COMPLETED | Study Drug Administration: Furosemide | 32 | |
| Period 2 (Subsequent 12 Weeks) | NOT COMPLETED | Study Drug Administration: Furosemide | 4 |
Source ClinicalTrials.gov
Adverse events12
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 | Inner EAR hearing assessment score decreased by >10 points from baseline | Ear and labyrinth disorders | Study Drug Administration: Furosemide | 3 | 39 | 4 |
| other | Hypotension during dialysis treatment | Renal and urinary disorders | Study Drug Administration: Furosemide | 2 | 39 | 2 |
| other | Severe tinnitus | Ear and labyrinth disorders | Study Drug Administration: Furosemide | 1 | 39 | 9 |
| serious | Hospitalization for stroke | Nervous system disorders | Study Drug Administration: Furosemide | 1 | 39 | 1 |
| serious | Hospitalization for cardiogenic shock | Cardiac disorders | Study Drug Administration: Furosemide | 1 | 39 | 1 |
| serious | Hospitalization for clostridium difficile infection | Infections and infestations | Study Drug Administration: Furosemide | 1 | 39 | 1 |
| serious | Hospitalization for COVID-19 infection | Infections and infestations | Study Drug Administration: Furosemide | 2 | 39 | 2 |
| serious | Death due to COVID-19-related respiratory failure | Infections and infestations | Study Drug Administration: Furosemide | 1 | 39 | 1 |
| serious | Hospitalization for acute respiratory failure due to volume overload | Respiratory, thoracic and mediastinal disorders | Study Drug Administration: Furosemide | 1 | 39 | 1 |
| serious | Hospitalization for non-ST-elevation myocardial infarction | Cardiac disorders | Study Drug Administration: Furosemide | 1 | 39 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Study Drug Administration: Furosemide | 2 | 39 |
| Total, other adverse events | Study Drug Administration: Furosemide | 6 | 39 |
| Total, serious adverse events | Study Drug Administration: Furosemide | 8 | 39 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| R03DK124651 | Pilot feasibility study of loop diuretics among individuals receiving hemodialysis | FLYTHE, JENNIFER E | UNIV OF NORTH CAROLINA CHAPEL HILL | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2020 to 2021 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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/NCT04622709
GET https://conductscience.org/api/trials/v1/NCT04622709/registered?page=2