Trial · NCT00585013
Inhaled NO as an Anti-inflammatory and Anti-reperfusion Agent in Infants and Children Undergoing Cardiopulmonary Bypass
NCT00585013, Phase 1, Phase 2, Completed, Washington University School of Medicine; results first posted 2015-11-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Inhaled NO as an Anti-inflammatory and Anti-reperfusion Agent in Infants and Children Undergoing Cardiopulmonary Bypass. Trials, record NCT00585013. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00585013
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Inhaled NO as an Anti-inflammatory and Anti-reperfusion Agent in Infants and Children Undergoing Cardiopulmonary Bypass
- NCT number
- NCT00585013
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Congenital Heart Disease
- Interventions
- Nitric Oxide
- First posted
- 2008-01-02
- Last updated
- 2015-11-04
- Results first posted
- 2015-11-04
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Serum Inflammatory Mediators Post CPB | 48 hours | Inflammation measured through the measurement inflammatory mediators, serum interleukin-6, serum interleukin-8, and tumor necrosis factor. Baseline (preoperative, 0h, 12h, 24h, and 48h. |
| Primary | Myocardial Injury | 48 hours | Troponin levels correlate with myocardial injury. Greater troponin levels represent greater myocardial injury |
| Primary | Myocardial Function as Measured by B-type Natiuretic Peptide (BNP) Levels | 48 hours | BNP levels correlate to ventricular and myocardial performance, function, and strain. Higher values represent greater strain and decreased function. |
| Primary | Ischemic Injury as Measured by Lactate Levels | 48 hours | Lactate levels correlate to ischemic injury. Higher values represent more injury. |
| Secondary | Incidence of Methhemoglobin >5%, Gene Expression Profiles, and S100B. | 48 hours |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Serum Inflammatory Mediators Post CPB | 48 hours | ng/mL | MEAN | |
| PRIMARY | Myocardial Injury | 48 hours | ng/mL | MEAN | |
| PRIMARY | Myocardial Function as Measured by B-type Natiuretic Peptide (BNP) Levels | 48 hours | pg/dL | MEAN | |
| PRIMARY | Ischemic Injury as Measured by Lactate Levels | 48 hours | mmol/L | MEAN | |
| SECONDARY | Incidence of Methhemoglobin >5%, Gene Expression Profiles, and S100B. | 48 hours | Data not collected for these assessments |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Serum Inflammatory Mediators Post CPB | Nitric Oxide Delivery Group | Interleukin-6 Preoperative | 3.8 | Standard Deviation 3.5 | ng/mL |
| Serum Inflammatory Mediators Post CPB | Placebo | Interleukin-6 Preoperative | 3.4 | Standard Deviation 2.5 | ng/mL |
| Serum Inflammatory Mediators Post CPB | Nitric Oxide Delivery Group | Interleukin-6, 0 hrs | 90.9 | Standard Deviation 44.6 | ng/mL |
| Serum Inflammatory Mediators Post CPB | Placebo | Interleukin-6, 0 hrs | 78.3 | Standard Deviation 45.7 | ng/mL |
| Serum Inflammatory Mediators Post CPB | Nitric Oxide Delivery Group | Interleukin-6, 12 hrs | 51.5 | Standard Deviation 38.7 | ng/mL |
| Serum Inflammatory Mediators Post CPB | Placebo | Interleukin-6, 12 hrs | 73.3 | Standard Deviation 67.0 | ng/mL |
| Serum Inflammatory Mediators Post CPB | Nitric Oxide Delivery Group | Interleukin-6, 24 hrs | 64.2 | Standard Deviation 28.4 | ng/mL |
| Serum Inflammatory Mediators Post CPB | Placebo | Interleukin-6, 24 hrs | 80.7 | Standard Deviation 82.1 | ng/mL |
| Serum Inflammatory Mediators Post CPB | Nitric Oxide Delivery Group | Interleukin-6, 48 hrs | 31.2 | Standard Deviation 30.6 | ng/mL |
| Serum Inflammatory Mediators Post CPB | Placebo | Interleukin-6, 48 hrs | 39.4 | Standard Deviation 48.9 | ng/mL |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 1 Treatment | 8 | |
| Overall Study | STARTED | 2 Placebo | 8 | |
| Overall Study | COMPLETED | 1 Treatment | 8 | |
| Overall Study | COMPLETED | 2 Placebo | 8 | |
| Overall Study | NOT COMPLETED | 1 Treatment | 0 | |
| Overall Study | NOT COMPLETED | 2 Placebo | 0 |
Source ClinicalTrials.gov
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 totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1 Treatment | ||
| Total, all-cause mortality | 2 Placebo | ||
| Total, other adverse events | 1 Treatment | 0 | 8 |
| Total, other adverse events | 2 Placebo | 0 | 8 |
| Total, serious adverse events | 1 Treatment | 0 | 8 |
| Total, serious adverse events | 2 Placebo | 0 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23228403 | DERIVED |
Source PubMed
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 |
|---|
| 1 Treatment vs 2 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/NCT00585013
GET https://conductscience.org/api/trials/v1/NCT00585013/results?page=2