Trial · NCT00590018
Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease
NCT00590018, Phase 2, Completed, Baylor College of Medicine; results first posted 2016-05-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease. Trials, record NCT00590018. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00590018
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Corticosteroids in Postoperative Critically Ill Neonates With Low Cardiac Output Syndrome With Congenital Heart Disease
- NCT number
- NCT00590018
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- Baylor College of Medicine
- Conditions
- Cardiac Output, Low
- Interventions
- Hydrocortisone, Placebo
- First posted
- 2008-01-10
- Last updated
- 2016-05-26
- Results first posted
- 2016-05-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Blood Pressure. | 2 days | Change in mean blood pressure recorded prior to (15 minutes prior to study drug) and subsequent to medication/placebo administration (at 2 days post drug administration). |
| Secondary | Change in Inotrope Score. This is the Change in the Inotrope Score Between 15 Minutes Prior to Drug Administration and at 2 Days After Drug Administration. | 2 days | Inotrope score: epinephrine (mcg/kg/min x 100) + norepinephrine (mcg/kg/min x 100) + phenylephrine (mcg/kg/min x 100) + dopamine (mcg/kg/min x1) + dobutamine (mcg/kg/min x 1) + milrinone (mcg/kg/min x15). A lower inotrope score is better with the minimum being 0 and the maximum being 85. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Blood Pressure. | 2 days | mmHg | MEAN | |
| SECONDARY | Change in Inotrope Score. This is the Change in the Inotrope Score Between 15 Minutes Prior to Drug Administration and at 2 Days After Drug Administration. | 2 days | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Blood Pressure. | Hydrocortisone | 6 | Standard Deviation 7.86 | mmHg | |
| Blood Pressure. | Placebo | 5.89 | Standard Deviation 9.24 | mmHg | |
| Change in Inotrope Score. This is the Change in the Inotrope Score Between 15 Minutes Prior to Drug Administration and at 2 Days After Drug Administration. | Hydrocortisone | 8.83 | Standard Deviation 9.61 | units on a scale | |
| Change in Inotrope Score. This is the Change in the Inotrope Score Between 15 Minutes Prior to Drug Administration and at 2 Days After Drug Administration. | Placebo | 7.17 | Standard Deviation 4.8 | units on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Hydrocortisone | 9 | |
| Overall Study | STARTED | Placebo | 9 | |
| Overall Study | COMPLETED | Hydrocortisone | 9 | |
| Overall Study | COMPLETED | Placebo | 9 | |
| Overall Study | NOT COMPLETED | Hydrocortisone | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Death | Cardiac disorders | Hydrocortisone | 0 | 9 | 0 |
| serious | Death | Cardiac disorders | Placebo | 1 | 9 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Hydrocortisone | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Hydrocortisone | 0 | 9 |
| Total, other adverse events | Placebo | 0 | 9 |
| Total, serious adverse events | Hydrocortisone | 0 | 9 |
| Total, serious adverse events | Placebo | 1 | 9 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Hydrocortisone vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT00590018
GET https://conductscience.org/api/trials/v1/NCT00590018/registered