Trial · NCT01301313
Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children
NCT01301313, Phase 2, Terminated, Jose Luis Vazquez Martinez
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children. Trials, record NCT01301313. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01301313
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Levosimendan in Severe Acute Heart Failure in Critical Children
- NCT number
- NCT01301313
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 116 participants, actual
- Lead sponsor
- Jose Luis Vazquez Martinez
- Conditions
- Acute Heart Failure
- Interventions
- Levosimendan, Conventional intensified inotropic treatment
- First posted
- 2011-02-23
- Last updated
- 2013-01-31
- Other registries' IDs
- eudract:2009-017827-24
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hemodynamic improvement at 24 hours | 24 hours | To evaluate the efficacy of levosimendan in the treatment of severe acute heart failure in children in critical conditions comparing the proportion of patients with hemodynamic improvement at 24 hours between the group who received levosimendan as rescue therapy (experimental treatment) versus the one who received intensified conventional inotropic treatment (control treatment) |
| Secondary | Improvement in cardiac output | 24 and 48 hours | To compare the improvement in cardiac output induced by levosimendan in the treatment of severe acute heart failure in critical children versus the intensified conventional inotropic treatment, at 24 and 48h |
| Secondary | Improvement in the neurohormonal profile | 24 and 48 hours | To compare the improvement in the neurohormonal profile (assessed as a reduction of BNP) induced by levosimendan in the treatment of severe acute heart failure in critical children versus the intensified conventional inotropic treatment, at 24 and 48h. |
| Secondary | Number of days of hospital stay in paediatric intensive care unit | 30 days | To compare the number of days of hospital stay in paediatric intensive care unit and the number of days on mechanical ventilation, at 30 days. |
| Secondary | Safety | 30 days | To assess the safety of the use of levosimendan in the treatment of severe acute heart failure in children in critical conditions, at 30 days. |
| Secondary | Survival | 30 days | Survival, at 30 days |
Source ClinicalTrials.gov
Outcomes0
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/NCT01301313
GET https://conductscience.org/api/trials/v1/NCT01301313/registered