Trial · NCT03823781
Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants
NCT03823781, Phase 3, Unknown, Shanghai Children's Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants. Trials, record NCT03823781. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03823781
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants
- NCT number
- NCT03823781
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 520 participants, estimated
- Lead sponsor
- Shanghai Children's Medical Center
- Conditions
- Low Cardiac Output Syndrome, Cardiac Surgical Procedures, Infant
- Interventions
- Milrinone, Normal saline
- First posted
- 2019-01-30
- Last updated
- 2019-01-30
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants died within 30 days postoperatively | up to 30 days postoperatively | |
| Primary | Number of participants developed low cardiac output syndrome within the first 36 hours after initiation of study drug | 36 hours after initiation of study drug | Low cardiac output syndrome was defined as the following: clinical signs or symptoms (eg, tachycardia, oliguria, poor perfusion, or cardiac arrest) with or without a widened arterial-mixed venous oxygen saturation difference or metabolic acidosis; mechanical support of the circulation (eg, extracorporeal life support, ventricular assist device), a cardiac index determined by Pulse indicator continuous cardiac output (PiCCO) of \<2.2 L/min/m2 |
| Secondary | Number of participants developed low cardiac output syndrome in the interval between 36 hours after initiation of study drug and the final Follow up. Cardiac index will be determined by Doppler echocardiography | up to 30 days postoperatively | |
| Secondary | Change in Vasoactive Inotrope Score. | 36 hours after initiation of study drug | Vasoactive Inotrope Score=100\*Epinephrine dose (ug/kg/min)+100\*Norepinephrine dose (ug/kg/min)+10\*Dopamine dose (ug/kg/min)+10\*Dobutamine dose (ug/kg/min) +10,000\*Vasopressin dose (units/kg/min) +10\*Milrinone dose (ug/kg/min) |
| Secondary | Length of intensive care stay. | up to 30 days postoperatively or until ICU discharge. | Length of intensive care stay will be calculated from date of ICU admission to date of ICU discharge |
| Secondary | Length of hospital stay. | up to 30 days postoperatively or until hospital discharge | Length of hospital stay will be calculated from date of hospital admission to date of hospital discharge |
| Secondary | Duration of mechanical ventilation. | up to 30 days postoperatively or until extubation | Duration of mechanical ventilation will be calculated from date and time of ICU admission to date and time of extubation |
| Secondary | Number of participants with improvement of ventriculoarterial coupling | 36 hours after initiation of study drug | ventriculoarterial coupling improvement will be assessed by means of ventriculoarterial coupling values shift closer to 1. ventriculoarterial coupling will be obtained as : (1-EF)/EF |
| Secondary | Number of participants requiring mechanical circulatory support. | up to 30 days postoperatively | eg. Extra-Corporeal Membrane Oxygenation, ventricular assist device |
| Secondary | Number of participants with a decrease in regional tissue oxygenation at least 20% from baseline. | 36 hours after initiation of study drug | Cerebral and abdominal regional tissue oxygenation will be monitored |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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/NCT03823781
GET https://conductscience.org/api/trials/v1/NCT03823781/registered