Trial · NCT05060523
To Study Effect of the Combination of Midodrine and Tolvaptan Versus Tolvaptan Alone in Patients With Severe Hyponatremia in Cirrhosis(TOLMINA Trial)
NCT05060523, Not applicable, Unknown, Institute of Liver and Biliary Sciences, India
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. To Study Effect of the Combination of Midodrine and Tolvaptan Versus Tolvaptan Alone in Patients With Severe Hyponatremia in Cirrhosis(TOLMINA Trial). Trials, record NCT05060523. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05060523
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- To Study Effect of the Combination of Midodrine and Tolvaptan Versus Tolvaptan Alone in Patients With Severe Hyponatremia in Cirrhosis(TOLMINA Trial)
- NCT number
- NCT05060523
- Status
- Unknown
- Phases
- Not applicable
- Enrollment
- 220 participants, estimated
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Conditions
- Liver Cirrhosis
- Interventions
- Tolvaptan Tablets, Midodrine Oral Tablet, Placebo
- First posted
- 2021-09-29
- Last updated
- 2021-11-29
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Improvement in Na+ to 125meq/L | 1 week | |
| Secondary | Improvement in Na + (120 -125 meq/L) | 3 days | |
| Secondary | Improvement in Na + (120 -125 meq/L) | 5 days | |
| Secondary | Changes in Serum osmolality | 0,1day,3day,1week ,2 week,1 month | Serum osmolality normal range is 285 to 295 millimol/kg |
| Secondary | Changes in urine volume | 0,1day,3day,1week ,2 week,1 month | |
| Secondary | Changes in urinay Na + excretion in body | 0,1day,3day,1week ,2 week,1 month | |
| Secondary | Change in clinical complications(AKI,HE) in patients with hyponatremia | 1 week,1month | |
| Secondary | Development of AKI | 7 day | Changes is serum creatine level more than 0.3 within 24 hours |
| Secondary | Failure to achieve sodium concentration to 125 meq/L | 7 day | |
| Secondary | Improvement in Na+ concentration from base line to 130 meq/l | Day 7 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT05060523
GET https://conductscience.org/api/trials/v1/NCT05060523/registered