Trial Outcomes & Findings for Nitric Oxide Administration During Pediatric Cardiopulmonary Bypass Surgery to Prevent Platelet Activation (NCT NCT03455218)

NCT ID: NCT03455218

Last Updated: 2020-08-13

Results Overview

Change in platelet count from baseline to conclusion of cardiopulmonary bypass = (Platelet count at end of CPB) - (Platelet count prior to start of CPB)

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 40 participants
• Primary outcome timeframe: From baseline to end of cardiopulmonary bypass (2-6 hours)
• Results posted on: 2020-08-13

Participant Flow

Participant milestones

Measure	Nitric Oxide 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator	Placebo INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator
Overall Study STARTED	18	22
Overall Study COMPLETED	18	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nitric Oxide Administration During Pediatric Cardiopulmonary Bypass Surgery to Prevent Platelet Activation

Baseline characteristics by cohort

Measure	Nitric Oxide n=18 Participants 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator	Placebo n=22 Participants INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator	Total n=40 Participants Total of all reporting groups
Age, Continuous	100.6 Days STANDARD_DEVIATION 77.7 • n=5 Participants	112.4 Days STANDARD_DEVIATION 92.5 • n=7 Participants	107.1 Days STANDARD_DEVIATION 85.3 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	19 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Weight	4.62 Kilogram STANDARD_DEVIATION 1.50 • n=5 Participants	4.80 Kilogram STANDARD_DEVIATION 1.48 • n=7 Participants	4.72 Kilogram STANDARD_DEVIATION 1.47 • n=5 Participants
Known Genetic Disorder	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
STAT Category STAT Category 1 & 2	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
STAT Category STAT Category 3-5	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Total Cardiopulmonary Bypass Time	123.5 Minutes n=5 Participants	115.0 Minutes n=7 Participants	115.0 Minutes n=5 Participants
Total Aortic Cross Clamp Time	77.4 Minutes STANDARD_DEVIATION 40.6 • n=5 Participants	74.1 Minutes STANDARD_DEVIATION 45.4 • n=7 Participants	75.6 Minutes STANDARD_DEVIATION 42.8 • n=5 Participants

PRIMARY outcome

Timeframe: From baseline to end of cardiopulmonary bypass (2-6 hours)

Change in platelet count from baseline to conclusion of cardiopulmonary bypass = (Platelet count at end of CPB) - (Platelet count prior to start of CPB)

Outcome measures

Measure	Nitric Oxide n=18 Participants 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator	Placebo n=22 Participants INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator
Change in Platelet Count	-221 Count of platelets Standard Deviation 107	-242 Count of platelets Standard Deviation 114

PRIMARY outcome

Timeframe: 30 days

30 day all cause mortality

Outcome measures

Measure	Nitric Oxide n=18 Participants 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator	Placebo n=22 Participants INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator
30 Day Mortality	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 6 months

Length of stay in the hospital following the operation

Outcome measures

Measure	Nitric Oxide n=18 Participants 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator	Placebo n=22 Participants INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator
Hospital Length of Stay	8 Days Interval 5.0 to 39.3	16.5 Days Interval 8.3 to 28.8

PRIMARY outcome

Timeframe: 24 hours

Methemoglobin levels in the blood measured at baseline

Outcome measures

Measure	Nitric Oxide n=18 Participants 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator	Placebo n=22 Participants INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator
Methemoglobin Level Pre-CPB	0.77 % methemoglobin Standard Deviation 0.42	0.99 % methemoglobin Standard Deviation 0.40

PRIMARY outcome

Timeframe: 4 hours

Methemoglobin Level obtained at the end of cardiopulmonary bypass

Outcome measures

Measure	Nitric Oxide n=18 Participants 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator	Placebo n=22 Participants INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator
Methemoglobin Level-End of CPB	1.56 % methemoglobin Standard Deviation 0.43	1.10 % methemoglobin Standard Deviation 0.43

PRIMARY outcome

Timeframe: 24 hours

Methemoglobin level obtained at the time of ICU Admit

Outcome measures

Measure	Nitric Oxide n=18 Participants 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator	Placebo n=22 Participants INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator
Methemoglobin Level-ICU Admit	1.3 % methemoglobin Standard Deviation 0.49	1.08 % methemoglobin Standard Deviation 0.29

SECONDARY outcome

Timeframe: From baseline to end of cardiopulmonary bypass (2-6 hours)

The P-selectin expression measured as a mean florescence was measured in platelets stimulated with thrombin receptor activating protein (TRAP) was measured at baseline and at conclusion of cardiopulmonary bypass. Mean of each assessment measured multiple times at each time point. Median change values were reported. The change in these values is the outcome measure = (Platelet response to TRAP at end of CPB) - (Platelet response to TRAP prior to CPB)

Outcome measures

Measure	Nitric Oxide n=18 Participants 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator	Placebo n=22 Participants INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator
Change in Platelet Response to TRAP as Measured by P-selectin Expression	24 Florescence arbitrary units Interval -6.0 to 39.0	30 Florescence arbitrary units Interval 7.0 to 58.0

SECONDARY outcome

Timeframe: From baseline to end of cardiopulmonary bypass (2-6 hours)

The P-selectin expression measured as a mean florescence was measured in platelets stimulated with U46619 was measured at baseline and at conclusion of cardiopulmonary bypass. Mean of each assessment measured multiple times at each time point. Median change values were reported. The change in these values is the outcome measure = (Platelet response to U46619 at end of CPB) - (Platelet response to U46619 prior to CPB)

Outcome measures

Measure	Nitric Oxide n=18 Participants 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator	Placebo n=22 Participants INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator
Change in Platelet Response to U46619 as Measured by P-selectin Expression	51 Florescence arbitrary units Interval 38.0 to 64.0	40 Florescence arbitrary units Interval 19.0 to 70.0

SECONDARY outcome

Timeframe: From baseline to end of cardiopulmonary bypass (2-6 hours)

The P-selectin expression measured as a mean florescence was measured in platelets stimulated with CRP was measured at baseline and at conclusion of cardiopulmonary bypass. Mean of each assessment measured multiple times at each time point. Median change values were reported. The change in these values is the outcome measure = (Platelet response to CRP at end of CPB) - (Platelet response to CRP prior to CPB)

Outcome measures

Measure	Nitric Oxide n=18 Participants 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator	Placebo n=22 Participants INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator
Change in Platelet Response to CRP as Measured by P-selectin Expression	23 Florescence arbitrary units Interval -3.0 to 42.0	23 Florescence arbitrary units Interval -6.0 to 50.0

SECONDARY outcome

Timeframe: 48 hours post-operatively

Volume per kg of platelet transfusion given to patient from the conclusion of cardiopulmonary bypass to 48 hours post-operatively

Outcome measures

Measure	Nitric Oxide n=18 Participants 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator	Placebo n=22 Participants INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator
Volume of Platelet Transfusion	4 mL/kg Interval 0.0 to 25.0	9.8 mL/kg Interval 0.0 to 32.6

SECONDARY outcome

Timeframe: 48 hours post-operatively

Volume per kg of packed red blood cell transfusion given to patient from the conclusion of cardiopulmonary bypass to 48 hours post-operatively

Outcome measures

Measure	Nitric Oxide n=18 Participants 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator	Placebo n=22 Participants INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator
Volume of Packed Red Blood Cell Transfusion	3.1 mL/kg Interval 0.0 to 19.1	0 mL/kg Interval 0.0 to 26.1

SECONDARY outcome

Timeframe: 48 hours post-operatively

Total number of transfusion exposures for a patient from the conclusion of cardiopulmonary bypass to 48 hours post-operatively

Outcome measures

Measure	Nitric Oxide n=18 Participants 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator	Placebo n=22 Participants INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator
Transfusion Exposures	2 Transfusions Interval 1.0 to 4.0	3 Transfusions Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: 30 days post-operatively

Time (days) spent on ventilator following the operation

Outcome measures

Measure	Nitric Oxide n=18 Participants 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator	Placebo n=22 Participants INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator
Length of Mechanical Ventilation	35.7 Hours Interval 0.0 to 111.5	28.2 Hours Interval 0.0 to 115.4

SECONDARY outcome

Timeframe: 24 hours post-operatively

Highest vasoactive infusion score (VIS) within 24 hours post-operatively. Vasoactive infusion score is based on the dose of the vasoactive infusions the patient is given VIS = Dopamine dose (μg/kg/min) + Dobutamine dose (μg/kg/min) +100 × epinephrine dose (μg/kg/min) + 10 X Milrinone dose (μg/kg/min) +10,000 × Vasopressin dose (U/kg/min) + 100 × Norepinephrine dose (μg/kg/min).

The minimum value is 0 if the patient is not on any vasoactive medications. There is no "maximum" score as there is no "maximum" dose of vasoactive medications. Higher scores indicate that the patient is on more vasoactive medications which is generally considered worse.

Outcome measures

Measure	Nitric Oxide n=18 Participants 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator	Placebo n=22 Participants INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator
Vasoactive Infusion Score	9 VIS Score Interval 6.3 to 16.1	9.5 VIS Score Interval 5.5 to 15.0

SECONDARY outcome

Timeframe: 48 hours post-operatively

Dichotomous outcome-required extracorporeal membrane oxygenation within 48 hours post-operatively

Outcome measures

Measure	Nitric Oxide n=18 Participants 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator	Placebo n=22 Participants INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator
Number of Subjects Requiring Extracorporeal Membrane Oxygenation	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months post-operatively

Total hospital cost at the time of discharge

Outcome measures

Measure	Nitric Oxide n=18 Participants 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator	Placebo n=22 Participants INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator
Hospital Cost	137.7 1000's of dollars Interval 99.5 to 490.7	224.3 1000's of dollars Interval 145.0 to 283.4

Adverse Events

Nitric Oxide

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nitric Oxide n=18 participants at risk 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator	Placebo n=22 participants at risk INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator
Cardiac disorders Cardiac Arrest	5.6% 1/18 • Number of events 1 • From the start of the operation till the time of hospital discharge. All patients were observed for adverse events from the start of the operation in which they were enrolled in the study till the time of hospital discharge following the operation. This ranged from 3 to 200 days. We used the definitions of major and minor adverse events as described by the Pediatric Cardiac Critical Care Consortium Database as this is a validated method to describe adverse events in pediatric patients following cardiac surgery.	4.5% 1/22 • Number of events 1 • From the start of the operation till the time of hospital discharge. All patients were observed for adverse events from the start of the operation in which they were enrolled in the study till the time of hospital discharge following the operation. This ranged from 3 to 200 days. We used the definitions of major and minor adverse events as described by the Pediatric Cardiac Critical Care Consortium Database as this is a validated method to describe adverse events in pediatric patients following cardiac surgery.
Cardiac disorders Heart block requiring pacemaker	5.6% 1/18 • Number of events 1 • From the start of the operation till the time of hospital discharge. All patients were observed for adverse events from the start of the operation in which they were enrolled in the study till the time of hospital discharge following the operation. This ranged from 3 to 200 days. We used the definitions of major and minor adverse events as described by the Pediatric Cardiac Critical Care Consortium Database as this is a validated method to describe adverse events in pediatric patients following cardiac surgery.	0.00% 0/22 • From the start of the operation till the time of hospital discharge. All patients were observed for adverse events from the start of the operation in which they were enrolled in the study till the time of hospital discharge following the operation. This ranged from 3 to 200 days. We used the definitions of major and minor adverse events as described by the Pediatric Cardiac Critical Care Consortium Database as this is a validated method to describe adverse events in pediatric patients following cardiac surgery.
Cardiac disorders Unplanned reoperation	5.6% 1/18 • Number of events 4 • From the start of the operation till the time of hospital discharge. All patients were observed for adverse events from the start of the operation in which they were enrolled in the study till the time of hospital discharge following the operation. This ranged from 3 to 200 days. We used the definitions of major and minor adverse events as described by the Pediatric Cardiac Critical Care Consortium Database as this is a validated method to describe adverse events in pediatric patients following cardiac surgery.	0.00% 0/22 • From the start of the operation till the time of hospital discharge. All patients were observed for adverse events from the start of the operation in which they were enrolled in the study till the time of hospital discharge following the operation. This ranged from 3 to 200 days. We used the definitions of major and minor adverse events as described by the Pediatric Cardiac Critical Care Consortium Database as this is a validated method to describe adverse events in pediatric patients following cardiac surgery.

Other adverse events

Measure	Nitric Oxide n=18 participants at risk 20 ppm of Nitric Oxide delivered to the oxygenator via the INOmax device for the duration of the cardiopulmonary bypass time Nitric Oxide: 20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass INOmax: All patients will have the INOmax device connected to the oxygenator	Placebo n=22 participants at risk INOmax device attached to the oxygenator, but no gas is delivered through the device Placebo: INOmax device connected to oxygenator, but no gas is delivered INOmax: All patients will have the INOmax device connected to the oxygenator
Cardiac disorders Arrhythmia requiring temporary pacemaker	38.9% 7/18 • Number of events 8 • From the start of the operation till the time of hospital discharge. All patients were observed for adverse events from the start of the operation in which they were enrolled in the study till the time of hospital discharge following the operation. This ranged from 3 to 200 days. We used the definitions of major and minor adverse events as described by the Pediatric Cardiac Critical Care Consortium Database as this is a validated method to describe adverse events in pediatric patients following cardiac surgery.	36.4% 8/22 • Number of events 8 • From the start of the operation till the time of hospital discharge. All patients were observed for adverse events from the start of the operation in which they were enrolled in the study till the time of hospital discharge following the operation. This ranged from 3 to 200 days. We used the definitions of major and minor adverse events as described by the Pediatric Cardiac Critical Care Consortium Database as this is a validated method to describe adverse events in pediatric patients following cardiac surgery.
Infections and infestations Sepsis	16.7% 3/18 • Number of events 3 • From the start of the operation till the time of hospital discharge. All patients were observed for adverse events from the start of the operation in which they were enrolled in the study till the time of hospital discharge following the operation. This ranged from 3 to 200 days. We used the definitions of major and minor adverse events as described by the Pediatric Cardiac Critical Care Consortium Database as this is a validated method to describe adverse events in pediatric patients following cardiac surgery.	4.5% 1/22 • Number of events 1 • From the start of the operation till the time of hospital discharge. All patients were observed for adverse events from the start of the operation in which they were enrolled in the study till the time of hospital discharge following the operation. This ranged from 3 to 200 days. We used the definitions of major and minor adverse events as described by the Pediatric Cardiac Critical Care Consortium Database as this is a validated method to describe adverse events in pediatric patients following cardiac surgery.
Respiratory, thoracic and mediastinal disorders Chylothorax	11.1% 2/18 • Number of events 2 • From the start of the operation till the time of hospital discharge. All patients were observed for adverse events from the start of the operation in which they were enrolled in the study till the time of hospital discharge following the operation. This ranged from 3 to 200 days. We used the definitions of major and minor adverse events as described by the Pediatric Cardiac Critical Care Consortium Database as this is a validated method to describe adverse events in pediatric patients following cardiac surgery.	9.1% 2/22 • Number of events 2 • From the start of the operation till the time of hospital discharge. All patients were observed for adverse events from the start of the operation in which they were enrolled in the study till the time of hospital discharge following the operation. This ranged from 3 to 200 days. We used the definitions of major and minor adverse events as described by the Pediatric Cardiac Critical Care Consortium Database as this is a validated method to describe adverse events in pediatric patients following cardiac surgery.
Cardiac disorders Pulmonary hypertension	11.1% 2/18 • Number of events 2 • From the start of the operation till the time of hospital discharge. All patients were observed for adverse events from the start of the operation in which they were enrolled in the study till the time of hospital discharge following the operation. This ranged from 3 to 200 days. We used the definitions of major and minor adverse events as described by the Pediatric Cardiac Critical Care Consortium Database as this is a validated method to describe adverse events in pediatric patients following cardiac surgery.	0.00% 0/22 • From the start of the operation till the time of hospital discharge. All patients were observed for adverse events from the start of the operation in which they were enrolled in the study till the time of hospital discharge following the operation. This ranged from 3 to 200 days. We used the definitions of major and minor adverse events as described by the Pediatric Cardiac Critical Care Consortium Database as this is a validated method to describe adverse events in pediatric patients following cardiac surgery.
Nervous system disorders Seizure	5.6% 1/18 • Number of events 1 • From the start of the operation till the time of hospital discharge. All patients were observed for adverse events from the start of the operation in which they were enrolled in the study till the time of hospital discharge following the operation. This ranged from 3 to 200 days. We used the definitions of major and minor adverse events as described by the Pediatric Cardiac Critical Care Consortium Database as this is a validated method to describe adverse events in pediatric patients following cardiac surgery.	4.5% 1/22 • Number of events 1 • From the start of the operation till the time of hospital discharge. All patients were observed for adverse events from the start of the operation in which they were enrolled in the study till the time of hospital discharge following the operation. This ranged from 3 to 200 days. We used the definitions of major and minor adverse events as described by the Pediatric Cardiac Critical Care Consortium Database as this is a validated method to describe adverse events in pediatric patients following cardiac surgery.

Additional Information

Robert Niebler, MD

Medical College of Wisconsin

Phone: 4142663360

Email: rniebler@mcw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place