An interventional study of Inhaled Nitric Oxide and placebo in Ischemia/Reperfusion Injury After Neonatal Cardiac Surgery and Inflammatory Reaction After Neonatal Cardiac Surgery, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 1 Day to 30 Days. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
Around 7500 neonates born yearly in the United States have complex congenital heart disease that require surgical repair in the first few days of life. The complexity of the surgical repair requires long periods of cardiopulmonary bypass (CPB) and the use of intermittent periods of low flow or complete circulatory arrest. The immature neonatal vital organs are more prone to the complications of the cardiopulmonary bypass circulation, namely ischemia/reperfusion (I/R) injury and systemic inflammatory response. Inhaled nitric oxide (NO) is used frequently in neonates for the treatment of pulmonary hypertension, Additionally, many studies have shown that NO has an anti-inflammatory effect by reducing I/R injury and endothelial dysfunction.
The purpose of this pilot study is to assess the efficacy of NO administration via the CPB circuit in attenuating the CPB induced I/R injury and systemic inflammatory reaction in neonates undergoing repair of complex congenital heart defects. Specific goals will be to demonstrate that NO use via CPB will:
Twelve neonates undergoing repair of complex congenital heart defects will receive NO via the CPB circuit, for the duration of surgery. They will be compared to a control group of 12 similar patients. Serum levels of different ischemic reperfusion injury and inflammatory markers will be measured at different time points after surgery and will be correlated with different end organ function tests and clinical course in the postoperative period. The results will be compared between the two groups to try to determine the clinical benefit of NO administration through CPB circuit.
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Exclusion Criteria:
neonates receiving inhaled NO into the cardiopulmonary bypass circuit during cardiac surgery
Drug: Inhaled Nitric Oxide
neonates not receiving inhaled NO into the cardiopulmonary bypass
Drug: placebo
delivering inhaled Nitric Oxide into the cardiopulmonary bypass circuit during neonatal cardiac surgery
Also known as: study group
inhaled Nitric Oxide not delivered to the cardiopulmonary bypass circuit during neonatal cardiac surgery
Also known as: control group
Change in Biochemical Markers of Ischemia/Reperfusion Injury and Oxidative Damage (Positive ~ Increase From Pre-op)
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.
Time frame: Pre-op baseline and up to 12 hours after surgery
Total Fluid Balance at 48 Hours
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.
Time frame: 48 hours post surgery
Time Until Start of Diuretic Therapy
hours until start of diuretic therapy
Time frame: Pre-op to 72 hours post surgery
Inotropic Score Day 1
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 )
Time frame: 24 hours post surgery
Length of Intubation and PSHU Stay
Days to extubation and Pediatric Surgical Heart Unit (PSHU) length of stay (LOS) as measuring patient surgical outcomes.
Time frame: Surgery to discharge
Surgical Morbidity
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..
Time frame: 1 month after cardiac surgery
| Milestone | Nitric Oxide on CPB | Control |
|---|---|---|
| Started | 12 | 12 |
| Completed | 12 | 12 |
| Not completed | 0 | 0 |
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.
| ng/ml | Nitric Oxide on CPB | Control |
|---|---|---|
| cardiac troponin I change | 0.46 ± 0.55 | 0.64 ± 0.64 |
| IL-6 change | 11.52 ± 12.98 | 26.98 ± 27.67 |
| IL-8 change | 49.36 ± 42.86 | 68.46 ± 81.09 |
| TNF alpha change | 0.03 ± 0.20 | -0.12 ± 0.21 |
| NT pro-BNP change | 7.03 ± 22.84 | 1.51 ± 2.29 |
| LDH change | 48.85 ± 117.39 | 53.44 ± 73.58 |
| Superoxide Dismutase change | -0.04 ± 0.04 | -0.05 ± 0.06 |
| Plasma MDA change | 7.61 ± 12.90 | 10.65 ± 14.99 |
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.
| ml/kg | Nitric Oxide on CPB | Control |
|---|---|---|
| Total Fluid Balance at 48 Hours | 32.24 (-52.90 to 165.26) | 15.93 (-160.55 to 73.245) |
hours until start of diuretic therapy
| hour | Nitric Oxide on CPB | Control |
|---|---|---|
| Time Until Start of Diuretic Therapy | 25 (22.5 to 30.25) | 21.5 (19.25 to 24) |
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 )
| mcg/kg/min | Nitric Oxide on CPB | Control |
|---|---|---|
| Inotropic Score Day 1 | 16.5 (12.75 to 19.75) | 15 (13.5 to 18.75) |
Days to extubation and Pediatric Surgical Heart Unit (PSHU) length of stay (LOS) as measuring patient surgical outcomes.
| days | Nitric Oxide on CPB | Control |
|---|---|---|
| Days to extubation | 7.5 (6.25 to 9.5) | 6.5 (5.25 to 14.75) |
| PSHU Length of Stay (LOS) | 15 (10.5 to 22.25) | 12 (11 to 15) |
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..
| Participants | Nitric Oxide on CPB | Control |
|---|---|---|
| Surgical Morbidity | 0 | 0 |
Collected over Adverse events (AEs) were collected for the entire hospitalization period, from surgical date to 104 days.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nitric Oxide on CPB | 0/12 (0%) | 0/12 (0%) | 2/12 (16.7%) |
| Control | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) |
| Event | Nitric Oxide on CPB | Control |
|---|---|---|
| ChylothoraxBlood and lymphatic system disorders | 1/12 | 0/12 |
| needed cath interventionCardiac disorders | 1/12 | 1/12 |
| Age, Categorical(Participants) | Nitric Oxide on CPB | Control | Total |
|---|---|---|---|
| <=18 years | 12 | 12 | 24 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(days) | Nitric Oxide on CPB | Control | Total |
|---|---|---|---|
| Mean | 5.67 ± 1.87 | 5.92 ± 1.78 | 5.79 ± 1.82 |
| Sex: Female, Male(Participants) | Nitric Oxide on CPB | Control | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 8 | 7 | 15 |
| Race (NIH/OMB)(Participants) | Nitric Oxide on CPB | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 5 |
| White | 10 | 9 | 19 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Nitric Oxide on CPB | Control | Total |
|---|---|---|---|
| United States | 12 | 12 | 24 |
| anatomical diagnosis, hypoplastic left heart syndrome(Participants) | Nitric Oxide on CPB | Control | Total |
|---|---|---|---|
| Count of participants | 10 | 11 | 21 |
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Studies of the drug tested here: Nitric Oxide
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