Trial Outcomes & Findings for Stress Response and Neurodevelopmental Outcome After Cardiac Surgery Utilizing CPB in Children: A Prospective, Double Blinded and Randomized Study (NCT NCT02492269)
NCT ID: NCT02492269
Last Updated: 2025-08-07
Results Overview
Cytokine levels in plasma samples will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
From baseline to 24 hrs post-op
Results posted on
2025-08-07
Participant Flow
Participant milestones
| Measure |
Dexmedetomidine
Dexmedetomidine in addition to 15 µg/kg of fentanyl
Dexmedetomidine
|
Placebo
Normal saline as a placebo in addition to 15 µg/kg of fentanyl
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
|
Overall Study
COMPLETED
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Dexmedetomidine
n=14 Participants
Dexmedetomidine in addition to 15 µg/kg of fentanyl
Dexmedetomidine
|
Placebo
n=16 Participants
Normal saline as a placebo in addition to 15 µg/kg of fentanyl
Placebo
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=14 Participants
|
16 Participants
n=16 Participants
|
30 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=14 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=30 Participants
|
|
Age, Continuous
|
6 months
STANDARD_DEVIATION 2 • n=14 Participants
|
6 months
STANDARD_DEVIATION 2 • n=16 Participants
|
6 months
STANDARD_DEVIATION 2 • n=30 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=14 Participants
|
6 Participants
n=16 Participants
|
10 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=14 Participants
|
10 Participants
n=16 Participants
|
20 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
16 participants
n=16 Participants
|
30 participants
n=30 Participants
|
|
Diagnosis
Ventricular Septal Defect
|
7 Participants
n=14 Participants
|
5 Participants
n=16 Participants
|
12 Participants
n=30 Participants
|
|
Diagnosis
Tetralogy of Fallot
|
6 Participants
n=14 Participants
|
9 Participants
n=16 Participants
|
15 Participants
n=30 Participants
|
|
Diagnosis
Atrioventricular septal defect
|
6 Participants
n=14 Participants
|
2 Participants
n=16 Participants
|
8 Participants
n=30 Participants
|
|
Weight
|
6 kilograms
STANDARD_DEVIATION 1 • n=14 Participants
|
7 kilograms
STANDARD_DEVIATION 1 • n=16 Participants
|
6.6 kilograms
STANDARD_DEVIATION 1 • n=30 Participants
|
PRIMARY outcome
Timeframe: From baseline to 24 hrs post-opCytokine levels in plasma samples will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively.
Outcome measures
| Measure |
Dexmedetomidine
n=14 Participants
Dexmedetomidine in addition to 15 µg/kg of fentanyl
Dexmedetomidine
|
Placebo
n=16 Participants
Normal saline as a placebo in addition to 15 µg/kg of fentanyl
Placebo
|
|---|---|---|
|
Change in Cytokine Levels
Baseline TNF-alpha
|
4.38 picograms per milliliter
Standard Deviation 1.63
|
4.2 picograms per milliliter
Standard Deviation 2.55
|
|
Change in Cytokine Levels
24 hr. post-op TNF-alph
|
2.68 picograms per milliliter
Standard Deviation 1.25
|
3.30 picograms per milliliter
Standard Deviation 2.43
|
|
Change in Cytokine Levels
Baseline IL-6
|
0.57 picograms per milliliter
Standard Deviation 0.71
|
0.96 picograms per milliliter
Standard Deviation 1.59
|
|
Change in Cytokine Levels
Post-sternotomy IL-6
|
0.61 picograms per milliliter
Standard Deviation 0.53
|
0.99 picograms per milliliter
Standard Deviation 1.29
|
|
Change in Cytokine Levels
End of surgery IL-6
|
11.95 picograms per milliliter
Standard Deviation 21.71
|
11.32 picograms per milliliter
Standard Deviation 14.73
|
|
Change in Cytokine Levels
Post-bypass IL-10
|
1.05 picograms per milliliter
Standard Deviation 1.02
|
1.24 picograms per milliliter
Standard Deviation 0.88
|
|
Change in Cytokine Levels
End of surgery IL-10
|
44.41 picograms per milliliter
Standard Deviation 48.95
|
78.27 picograms per milliliter
Standard Deviation 54.11
|
|
Change in Cytokine Levels
24 hr. post-op IL-10
|
1.37 picograms per milliliter
Standard Deviation 0.51
|
1.62 picograms per milliliter
Standard Deviation 1.03
|
|
Change in Cytokine Levels
Post-sternotomy TNF-alpha
|
3.98 picograms per milliliter
Standard Deviation 1.58
|
3.85 picograms per milliliter
Standard Deviation 2.37
|
|
Change in Cytokine Levels
Post-bypass TNF-alpha
|
2.88 picograms per milliliter
Standard Deviation 1.14
|
2.72 picograms per milliliter
Standard Deviation 1.76
|
|
Change in Cytokine Levels
End of surgery TNF-alpha
|
3.12 picograms per milliliter
Standard Deviation 1.94
|
2.96 picograms per milliliter
Standard Deviation 1.7
|
|
Change in Cytokine Levels
Post-bypass IL-6
|
0.87 picograms per milliliter
Standard Deviation 0.59
|
1.19 picograms per milliliter
Standard Deviation 1.3
|
|
Change in Cytokine Levels
24 hr. post-op IL-6
|
30.2 picograms per milliliter
Standard Deviation 17.04
|
41.93 picograms per milliliter
Standard Deviation 74.34
|
|
Change in Cytokine Levels
Baseline IL-8
|
6.55 picograms per milliliter
Standard Deviation 5.02
|
7.28 picograms per milliliter
Standard Deviation 5.61
|
|
Change in Cytokine Levels
Post-sternotomy IL-8
|
6.8 picograms per milliliter
Standard Deviation 4.68
|
8.46 picograms per milliliter
Standard Deviation 6.03
|
|
Change in Cytokine Levels
Post-bypass IL-8
|
7.04 picograms per milliliter
Standard Deviation 5.26
|
8.35 picograms per milliliter
Standard Deviation 5.94
|
|
Change in Cytokine Levels
End of surgery IL-8
|
28.83 picograms per milliliter
Standard Deviation 28.97
|
34.37 picograms per milliliter
Standard Deviation 32.76
|
|
Change in Cytokine Levels
24 hr. post-op IL-8
|
20.86 picograms per milliliter
Standard Deviation 16.76
|
32.52 picograms per milliliter
Standard Deviation 29.81
|
|
Change in Cytokine Levels
Baseline IL-10
|
0.27 picograms per milliliter
Standard Deviation 0.62
|
0.9 picograms per milliliter
Standard Deviation 0.65
|
|
Change in Cytokine Levels
Post-sternotomy IL-10
|
0.87 picograms per milliliter
Standard Deviation 0.46
|
1.26 picograms per milliliter
Standard Deviation 0.89
|
PRIMARY outcome
Timeframe: From baseline to 24 hrs post-opACTH, cortisol, epinephrine, \& norepinephrine will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively.
Outcome measures
| Measure |
Dexmedetomidine
n=14 Participants
Dexmedetomidine in addition to 15 µg/kg of fentanyl
Dexmedetomidine
|
Placebo
n=16 Participants
Normal saline as a placebo in addition to 15 µg/kg of fentanyl
Placebo
|
|---|---|---|
|
Change in Hormone Levels
Baseline ACTH
|
150.10 picograms per milliliter
Standard Deviation 119.78
|
139.48 picograms per milliliter
Standard Deviation 96.11
|
|
Change in Hormone Levels
Post-bypass Epinephrine
|
830.45 picograms per milliliter
Standard Deviation 757.89
|
830.73 picograms per milliliter
Standard Deviation 488.22
|
|
Change in Hormone Levels
End of surgery Epinephrine
|
203.73 picograms per milliliter
Standard Deviation 103.58
|
423.06 picograms per milliliter
Standard Deviation 406.03
|
|
Change in Hormone Levels
24 hr. post-op Epinephrine
|
172.05 picograms per milliliter
Standard Deviation 235.48
|
154.05 picograms per milliliter
Standard Deviation 176.39
|
|
Change in Hormone Levels
Baseline Norepinephrine
|
492.58 picograms per milliliter
Standard Deviation 475.2
|
696.5 picograms per milliliter
Standard Deviation 568.89
|
|
Change in Hormone Levels
End of surgery Norepinephrine
|
229.32 picograms per milliliter
Standard Deviation 207.5
|
477.66 picograms per milliliter
Standard Deviation 745.6
|
|
Change in Hormone Levels
24 hr. post-op Norepinephrine
|
913.12 picograms per milliliter
Standard Deviation 950.97
|
1320.9 picograms per milliliter
Standard Deviation 2263.32
|
|
Change in Hormone Levels
Post-sternotomy Norepinephrine
|
545.88 picograms per milliliter
Standard Deviation 656.81
|
891.86 picograms per milliliter
Standard Deviation 966.44
|
|
Change in Hormone Levels
Post-bypass Norepinephrine
|
499.37 picograms per milliliter
Standard Deviation 428.34
|
1145.05 picograms per milliliter
Standard Deviation 1281.1
|
|
Change in Hormone Levels
Post-sternotomy ACTH
|
105.63 picograms per milliliter
Standard Deviation 141.15
|
94.2 picograms per milliliter
Standard Deviation 93.8
|
|
Change in Hormone Levels
Post-bypass ACTH
|
108.09 picograms per milliliter
Standard Deviation 114.86
|
199.34 picograms per milliliter
Standard Deviation 160.34
|
|
Change in Hormone Levels
End of surgery ACTH
|
186.69 picograms per milliliter
Standard Deviation 170.06
|
201.49 picograms per milliliter
Standard Deviation 171.01
|
|
Change in Hormone Levels
24 hr. post-op ACTH
|
18.21 picograms per milliliter
Standard Deviation 9.8
|
26.78 picograms per milliliter
Standard Deviation 19.19
|
|
Change in Hormone Levels
Baseline Cortisol
|
448.27 picograms per milliliter
Standard Deviation 187.73
|
293.92 picograms per milliliter
Standard Deviation 138.53
|
|
Change in Hormone Levels
Post-sternotomy Cortisol
|
449.71 picograms per milliliter
Standard Deviation 144.4
|
316.58 picograms per milliliter
Standard Deviation 264.12
|
|
Change in Hormone Levels
Post-bypass Cortisol
|
314.42 picograms per milliliter
Standard Deviation 81.66
|
298.64 picograms per milliliter
Standard Deviation 217.82
|
|
Change in Hormone Levels
End of surgery Cortisol
|
553.88 picograms per milliliter
Standard Deviation 220.52
|
474.66 picograms per milliliter
Standard Deviation 256.16
|
|
Change in Hormone Levels
24 hr. post-op Cortisol
|
344.83 picograms per milliliter
Standard Deviation 344.79
|
357.3 picograms per milliliter
Standard Deviation 475.88
|
|
Change in Hormone Levels
Baseline Epinephrine
|
108.26 picograms per milliliter
Standard Deviation 98.2
|
112.13 picograms per milliliter
Standard Deviation 145.52
|
|
Change in Hormone Levels
Post-sternotomy Epinephrine
|
250.1 picograms per milliliter
Standard Deviation 261.97
|
379.68 picograms per milliliter
Standard Deviation 344.15
|
PRIMARY outcome
Timeframe: From baseline to 1 year post-opChildren will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested prior to discharge from the hospital, at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress. Mean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay. Score below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment.
Outcome measures
| Measure |
Dexmedetomidine
n=14 Participants
Dexmedetomidine in addition to 15 µg/kg of fentanyl
Dexmedetomidine
|
Placebo
n=16 Participants
Normal saline as a placebo in addition to 15 µg/kg of fentanyl
Placebo
|
|---|---|---|
|
Change in Bayley Cognitive Composite Scores
Baseline
|
102.14 score on a scale
Standard Deviation 11.04
|
95 score on a scale
Standard Deviation 16.12
|
|
Change in Bayley Cognitive Composite Scores
1-3 month post-op
|
102.86 score on a scale
Standard Deviation 14.9
|
96.82 score on a scale
Standard Deviation 17.07
|
|
Change in Bayley Cognitive Composite Scores
6 months post-op
|
98.57 score on a scale
Standard Deviation 7.95
|
97.27 score on a scale
Standard Deviation 16.49
|
|
Change in Bayley Cognitive Composite Scores
Prior to discharge
|
102.14 score on a scale
Standard Deviation 13.26
|
88.33 score on a scale
Standard Deviation 17.49
|
|
Change in Bayley Cognitive Composite Scores
1 yr. post-op
|
94.64 score on a scale
Standard Deviation 12.0
|
94.09 score on a scale
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: From baseline to 1 year post-opChildren will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested prior to discharge from the hospital, at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress. Mean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay. Score below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment.
Outcome measures
| Measure |
Dexmedetomidine
n=14 Participants
Dexmedetomidine in addition to 15 µg/kg of fentanyl
Dexmedetomidine
|
Placebo
n=16 Participants
Normal saline as a placebo in addition to 15 µg/kg of fentanyl
Placebo
|
|---|---|---|
|
Change in Bayley Language Composite Scores
Prior to discharge
|
91.14 score on a scale
Standard Deviation 20.0
|
77.6 score on a scale
Standard Deviation 12.26
|
|
Change in Bayley Language Composite Scores
1 yr. post-op
|
93.08 score on a scale
Standard Deviation 13.1
|
91.2 score on a scale
Standard Deviation 18.64
|
|
Change in Bayley Language Composite Scores
Baseline
|
98.14 score on a scale
Standard Deviation 13.95
|
86.81 score on a scale
Standard Deviation 14.45
|
|
Change in Bayley Language Composite Scores
1-3 month post-op
|
92.5 score on a scale
Standard Deviation 13.35
|
92.36 score on a scale
Standard Deviation 14.43
|
|
Change in Bayley Language Composite Scores
6 months post-op
|
86 score on a scale
Standard Deviation 11.81
|
91.36 score on a scale
Standard Deviation 8.98
|
SECONDARY outcome
Timeframe: From baseline to 1 year post-opChildren will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress. Mean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay. Score below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment.
Outcome measures
| Measure |
Dexmedetomidine
n=14 Participants
Dexmedetomidine in addition to 15 µg/kg of fentanyl
Dexmedetomidine
|
Placebo
n=16 Participants
Normal saline as a placebo in addition to 15 µg/kg of fentanyl
Placebo
|
|---|---|---|
|
Change in Bayley Motor Composite Scores
1 yr. post-op
|
91.69 score on a scale
Standard Deviation 10.62
|
87.5 score on a scale
Standard Deviation 17.37
|
|
Change in Bayley Motor Composite Scores
Baseline
|
95.14 score on a scale
Standard Deviation 15.02
|
84.2 score on a scale
Standard Deviation 15.89
|
|
Change in Bayley Motor Composite Scores
1-3 month post-op
|
92.07 score on a scale
Standard Deviation 13.9
|
84.27 score on a scale
Standard Deviation 16.84
|
|
Change in Bayley Motor Composite Scores
6 months post-op
|
92 score on a scale
Standard Deviation 13.98
|
87.18 score on a scale
Standard Deviation 10.66
|
Adverse Events
Dexmedetomidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place