Trial · NCT02320669
Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass
NCT02320669, Phase 3, Completed, Seattle Children's Hospital; results first posted 2024-04-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass. Trials, record NCT02320669. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02320669
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass
- NCT number
- NCT02320669
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 220 participants, actual
- Lead sponsor
- Seattle Children's Hospital
- Conditions
- Congenital Heart Defects
- Interventions
- Triostat, Placebo
- First posted
- 2014-12-19
- Last updated
- 2024-04-09
- Results first posted
- 2024-04-09
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time To Extubation | 30 days | time on mechanical ventilation after aortic cross clamp removal |
| Secondary | ICU Length of Stay | 30 days | Length of stay in the ICU |
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 | Time To Extubation | 30 days | modified intention to treat | hours | MEDIAN |
| SECONDARY | ICU Length of Stay | 30 days | Children under age 5 mos undergoing cardiopulmonary bypass | days | MEDIAN |
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 |
|---|---|---|---|---|---|
| Time To Extubation | Triostat | 46.9 | 95% Confidence Interval 25.9 to 71.6 | hours | |
| Time To Extubation | Placebo | 48.0 | 95% Confidence Interval 31.0 to 65.4 | hours | |
| ICU Length of Stay | Triiodothyronine | 3.5 | 95% Confidence Interval 2.3 to 4.8 | days | |
| ICU Length of Stay | Placebo | 2.9 | 95% Confidence Interval 2.4 to 3.8 | days |
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 | Triiodothyronine | 110 | |
| Overall Study | STARTED | Placebo | 110 | |
| Overall Study | COMPLETED | Triiodothyronine | 104 | |
| Overall Study | COMPLETED | Placebo | 107 | |
| Overall Study | NOT COMPLETED | Triiodothyronine | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events4
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 | Cardiac Arrhythmia | Cardiac disorders | Triostat | 17 | 110 | 110 |
| other | Cardiac Arrhythmia | Cardiac disorders | Placebo | 20 | 110 | 110 |
| serious | Sentinel | Cardiac disorders | Triostat | 11 | 110 | 11 |
| serious | Sentinel | Cardiac disorders | Placebo | 11 | 110 | 11 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Triostat | 6 | 110 |
| Total, all-cause mortality | Placebo | 3 | 110 |
| Total, other adverse events | Triostat | 17 | 110 |
| Total, other adverse events | Placebo | 20 | 110 |
| Total, serious adverse events | Triostat | 11 | 110 |
| Total, serious adverse events | Placebo | 11 | 110 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35093535 | RESULT |
Source PubMed
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 |
|---|---|---|---|---|---|
| R01FD004362 | Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass | PORTMAN, MICHAEL A | SEATTLE CHILDREN'S HOSPITAL | FOOD AND DRUG ADMINISTRATION | 2014 to 2017 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Triostat vs Placebo: deaths from any cause | Trial comparisons |
| Triostat vs Placebo: serious adverse events | 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/NCT02320669
GET https://conductscience.org/api/trials/v1/NCT02320669/registered