Trial · NCT02151877
Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass
NCT02151877, Not applicable, Completed, Wake Forest University Health Sciences; results first posted 2020-04-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass. Trials, record NCT02151877. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02151877
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass
- NCT number
- NCT02151877
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 24 participants, actual
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Ischemia/Reperfusion Injury After Neonatal Cardiac Surgery, Inflammatory Reaction After Neonatal Cardiac Surgery
- Interventions
- Inhaled Nitric Oxide, placebo
- First posted
- 2014-06-02
- Last updated
- 2024-10-08
- Results first posted
- 2020-04-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op) | Pre-op baseline and up to 12 hours after surgery | The primary study endpoints are to evaluate whether NO delivered through the neonatal cardiopulmonary bypass (CPB) circuit can decrease various biochemical markers of ischemia/reperfusion injury and oxidative damage. Markers to be analyzed will include cardiac troponin I, interleukins (IL), tumor necrosis factor, N-terminal prohormone for brain natriuretic peptide (NT-proBNP),lactate dehydrogenase (LDH), plasma anti-oxidant levels, plasma malondialdehyde (MDA) levels. |
| Secondary | Total Fluid Balance at 48 Hours | 48 hours post surgery | The secondary study endpoints are to evaluate whether NO delivered through the neonatal CPB circuit can decrease the clinical signs of ischemia/reperfusion injury and/or cardiac dysfunction. Clinical parameters (post surgery) include inotropic support, fluid balances, diuretic support, ventilator times, and length of ICU stay will be evaluated. |
| Secondary | Time Until Start of Diuretic Therapy | Pre-op to 72 hours post surgery | hours until start of diuretic therapy |
| Secondary | Inotropic Score Day 1 | 24 hours post surgery | The Inotropic Score is an objective clinical tool used to quantify the need for cardiovascular support in children and adolescents after surgery and to predict prognosis of pediatric septic shock (higher score predicts higher risk or worse prognosis).The Inotropic Score is low if \<= 20, intermediate if 21-30, and high if \> 30. Formula used in the study: Daily inotropic score (mcg/kg/min) = Dopamine drip dose+ dobutamine drip dose+ (milrinone drip dose times 10) + (epinephrine drip dose times 100 ) |
| Secondary | Length of Intubation and PSHU Stay | Surgery to discharge | Days to extubation and Pediatric Surgical Heart Unit (PSHU) length of stay (LOS) as measuring patient surgical outcomes. |
| Other | Surgical Morbidity | 1 month after cardiac surgery | include all complications that may happen after cardiac surgery for the whole period of hospital stay, that is expected to be around 1 month. This include renal failure, prolonged intubation and ventilatory support, infections.. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op) | Pre-op baseline and up to 12 hours after surgery | Intent to treat (ITT) | ng/ml | MEAN |
| SECONDARY | Total Fluid Balance at 48 Hours | 48 hours post surgery | Intent to treat | ml/kg | MEDIAN |
| SECONDARY | Time Until Start of Diuretic Therapy | Pre-op to 72 hours post surgery | Intent to treat | hour | MEDIAN |
| SECONDARY | Inotropic Score Day 1 | 24 hours post surgery | ITT | mcg/kg/min | MEDIAN |
| SECONDARY | Length of Intubation and PSHU Stay | Surgery to discharge | ITT | days | MEDIAN |
| OTHER_PRE_SPECIFIED | Surgical Morbidity | 1 month after cardiac surgery | Intent to treat | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op) | Nitric Oxide on CPB | cardiac troponin I change | 0.46 | Standard Deviation 0.55 | ng/ml |
| Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op) | Control | cardiac troponin I change | 0.64 | Standard Deviation 0.64 | ng/ml |
| Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op) | Nitric Oxide on CPB | IL-6 change | 11.52 | Standard Deviation 12.98 | ng/ml |
| Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op) | Control | IL-6 change | 26.98 | Standard Deviation 27.67 | ng/ml |
| Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op) | Nitric Oxide on CPB | IL-8 change | 49.36 | Standard Deviation 42.86 | ng/ml |
| Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op) | Control | IL-8 change | 68.46 | Standard Deviation 81.09 | ng/ml |
| Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op) | Nitric Oxide on CPB | TNF alpha change | 0.03 | Standard Deviation 0.20 | ng/ml |
| Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op) | Control | TNF alpha change | -0.12 | Standard Deviation 0.21 | ng/ml |
| Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op) | Nitric Oxide on CPB | NT pro-BNP change | 7.03 | Standard Deviation 22.84 | ng/ml |
| Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op) | Control | NT pro-BNP change | 1.51 | Standard Deviation 2.29 | ng/ml |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nitric Oxide on CPB | 12 | |
| Overall Study | STARTED | Control | 12 | |
| Overall Study | COMPLETED | Nitric Oxide on CPB | 12 | |
| Overall Study | COMPLETED | Control | 12 | |
| Overall Study | NOT COMPLETED | Nitric Oxide on CPB | 0 | |
| Overall Study | NOT COMPLETED | Control | 0 |
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 | Chylothorax | Blood and lymphatic system disorders | Nitric Oxide on CPB | 1 | 12 | 1 |
| other | Chylothorax | Blood and lymphatic system disorders | Control | 0 | 12 | 0 |
| other | needed cath intervention | Cardiac disorders | Nitric Oxide on CPB | 1 | 12 | 1 |
| other | needed cath intervention | Cardiac disorders | Control | 1 | 12 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nitric Oxide on CPB | 0 | 12 |
| Total, all-cause mortality | Control | 0 | 12 |
| Total, other adverse events | Nitric Oxide on CPB | 2 | 12 |
| Total, other adverse events | Control | 1 | 12 |
| Total, serious adverse events | Nitric Oxide on CPB | 0 | 12 |
| Total, serious adverse events | Control | 0 | 12 |
Source ClinicalTrials.gov
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nitric Oxide on CPB vs Control: Surgical Morbidity | Trial comparisons |
| Nitric Oxide on CPB vs Control: deaths from any cause | Trial comparisons |
| Nitric Oxide on CPB vs Control: 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/NCT02151877
GET https://conductscience.org/api/trials/v1/NCT02151877/results?page=2