Trial · NCT00848393
Measures to Lower the Stress Response in Pediatric Cardiac Surgery
NCT00848393, Phase 2, Completed, Nationwide Children's Hospital; results first posted 2018-07-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Measures to Lower the Stress Response in Pediatric Cardiac Surgery. Trials, record NCT00848393. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00848393
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Measures to Lower the Stress Response in Pediatric Cardiac Surgery
- NCT number
- NCT00848393
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 52 participants, actual
- Lead sponsor
- Nationwide Children's Hospital
- Conditions
- Tetralogy of Fallot (TOF), Ventricular Septal Defects (VSD), Atrioventricular Septal Defects (AVSD)
- Interventions
- Fentanyl (High Dose), Fentanyl (Low Dose), Fentanyl (Low Dose) + Dexmedetomidine
- First posted
- 2009-02-20
- Last updated
- 2018-07-27
- Results first posted
- 2018-07-27
- Limitations and caveats
Small sample size related to: study components conceived after completion of initial stress response study, declined participation, and loss to follow-up. Inability to obtain pre-surgical baseline neurodevelopmental evaluations.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ACTH and Cytokine Levels | Blood draws to measure cytokines levels within one hour of draw: after induction; after sternotomy; after starting cardiopulmonary bypass; at the end of the procedure; and 24 hours after the procedure. | N = 48 n = 16 (LDF); n = 17 (HDF); n = 15 (LDF + Dex) ACTH assayed by enzyme-linked immunosorbent assay (ELISA); Cytokine levels in plasma were measured using the Immulite automated chemiluminometer. Measured cytokines include interleukin (IL)-6, IL-8, IL-10, and tumor necrosis factor-α. |
| Primary | Comparisons Between Groups for Narcotic and/or Dexmedetomidine Intervention Influence on Length of CTICU Stay. | Hospital admission to discharge from CTICU (average of 2-4 days) | |
| Primary | Comparisons Between Groups for Narcotic and/or Dexmedetomidine Intervention Influence on Time on Ventilator. | Time of intubation to extubation (variable) | |
| Primary | Stanford-Binet Intelligence Scales | 1-4 yrs. post-surgery | The Stanford-Binet test evaluates the overall IQ score from the assessment of cognitive ability. The test consists of 15 subtests, grouped into the four area scores. Six subtests are administered to all age levels. The subtests are: Vocabulary, Comprehension, Pattern Analysis, Quantitative, Bead Memory, and Memory for Sentences. Number of tests administered and test difficulty are based on the test taker's age and performance on subtest measuring word knowledge. The word knowledge subtest is given to all test takers and is the first subtest administered. A score of 100 is in the normal or average range. Higher scores suggest a higher level of functioning related to each category. (University of Cincinnati, 2003) Raw scores for each subtest within the overall test are converted to scaled scores using a table within each test manual to look up equivalents. Scaled scores are then converted to standard scores (range=50-150). |
| Primary | Stress Hormone Levels | Blood draws to measure stress hormone levels within one hour of draw: after induction; after sternotomy; after starting cardiopulmonary bypass; at the end of the procedure; and 24 hours after the procedure. | Cortisol, epinephrine, and norepinephrine assayed by enzyme-linked immunosorbent assay (ELISA). |
| Secondary | Stanford-Binet Cognitive Ability | 1-4 yrs post-surgery | The Stanford-Binet Intelligence Scale is now in its fifth edition (SB5) and was released in 2003. It is a cognitive ability and intelligence test that is used to diagnose developmental or intellectual deficiencies in young children. The test measures five weighted factors and consists of both verbal and nonverbal subtests. The five factors being tested are knowledge, quantitative reasoning, visual-spatial processing, working memory, and fluid reasoning. Raw scores for each subtest within the overall test are converted to scaled scores using a table within each test manual to look up equivalents. Scaled scores are then converted to standard scores (range=50-150). Higher scores suggest a higher level of functioning related to each category. |
| Secondary | ABAS-II | 1-4 yrs post-surgery | The ABAS-II is designed to evaluate whether an individual displays various functional skills necessary for daily living without the assistance of others. Thus, this instrument focuses on independent behaviors and measures what an individual actually does, in addition to measuring what he or she may be able to do. In addition, the ABAS-II focuses on behaviors an individual displays on his or her own, without assistance from others. The Parent/Primary Caregiver Form is a comprehensive, diagnostic measure of the adaptive skills that have primary relevance for the functioning of infants, toddlers, and preschoolers in the home and other settings, and can be completed by parents or other primary care providers. Each composite or domain score is determined by summing the appropriate scaled scores and then determining its equivalent composite or domain score by looking it up in a table located in the manual.The range for all scores is 50-150, with a higher score equaling a better outcome. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | ACTH and Cytokine Levels | Blood draws to measure cytokines levels within one hour of draw: after induction; after sternotomy; after starting cardiopulmonary bypass; at the end of the procedure; and 24 hours after the procedure. | pg/mL | MEAN | |
| PRIMARY | Comparisons Between Groups for Narcotic and/or Dexmedetomidine Intervention Influence on Length of CTICU Stay. | Hospital admission to discharge from CTICU (average of 2-4 days) | Days | MEDIAN | |
| PRIMARY | Comparisons Between Groups for Narcotic and/or Dexmedetomidine Intervention Influence on Time on Ventilator. | Time of intubation to extubation (variable) | Hours | MEDIAN | |
| PRIMARY | Stanford-Binet Intelligence Scales | 1-4 yrs. post-surgery | Six patients underwent their surgical repair after 1 y of age and were excluded from the follow-up neurodevelopmental testing post-surgery. 2 patients were deceased, 11 families refused to participate, 8 patients could not be reached due to relocation to other states or outside the country leaving a total of 21 patients. | IQ | MEAN |
| PRIMARY | Stress Hormone Levels | Blood draws to measure stress hormone levels within one hour of draw: after induction; after sternotomy; after starting cardiopulmonary bypass; at the end of the procedure; and 24 hours after the procedure. | ng/mL | MEAN | |
| SECONDARY | Stanford-Binet Cognitive Ability | 1-4 yrs post-surgery | Six patients underwent their surgical repair after 1 y of age and were excluded from the follow-up neurodevelopmental testing post-surgery. 2 patients were deceased, 11 families refused to participate, 8 patients could not be reached due to relocation to other states or outside the country leaving a total of 21 patients. | units on a scale | MEAN |
| SECONDARY | ABAS-II | 1-4 yrs post-surgery | Six patients underwent their surgical repair after 1 y of age and were excluded from the follow-up neurodevelopmental testing post-surgery. 2 patients were deceased, 11 families refused to participate, 8 patients could not be reached due to relocation to other states or outside the country leaving a total of 21 patients. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group162
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| ACTH and Cytokine Levels | Fentanyl (High Dose) | Baseline ACTH (pg/mL) | 116.9 | Standard Deviation 117.0 | pg/mL |
| ACTH and Cytokine Levels | Fentanyl (Low Dose) | Baseline ACTH (pg/mL) | 182.7 | Standard Deviation 111.3 | pg/mL |
| ACTH and Cytokine Levels | Fentanyl (Low Dose) + Dexmedetomidine | Baseline ACTH (pg/mL) | 135.3 | Standard Deviation 129.8 | pg/mL |
| ACTH and Cytokine Levels | Fentanyl (High Dose) | Post-Sternotomy ACTH (pg/mL) | 44.5 | Standard Deviation 39.7 | pg/mL |
| ACTH and Cytokine Levels | Fentanyl (Low Dose) | Post-Sternotomy ACTH (pg/mL) | 86.2 | Standard Deviation 76.5 | pg/mL |
| ACTH and Cytokine Levels | Fentanyl (Low Dose) + Dexmedetomidine | Post-Sternotomy ACTH (pg/mL) | 106.9 | Standard Deviation 153.5 | pg/mL |
| ACTH and Cytokine Levels | Fentanyl (High Dose) | Post-Bypass ACTH (pg/mL) | 57.2 | Standard Deviation 61.2 | pg/mL |
| ACTH and Cytokine Levels | Fentanyl (Low Dose) | Post-Bypass ACTH (pg/mL) | 172.7 | Standard Deviation 121.8 | pg/mL |
| ACTH and Cytokine Levels | Fentanyl (Low Dose) + Dexmedetomidine | Post-Bypass ACTH (pg/mL) | 191.6 | Standard Deviation 220.2 | pg/mL |
| ACTH and Cytokine Levels | Fentanyl (High Dose) | End-Of-Surgery ACTH (pg/mL) | 66.4 | Standard Deviation 77.9 | pg/mL |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fentanyl (High Dose) | 17 | |
| Overall Study | STARTED | Fentanyl (Low Dose) | 16 | |
| Overall Study | STARTED | Fentanyl (Low Dose) + Dexmedetomidine | 18 | |
| Overall Study | COMPLETED | Fentanyl (High Dose) | 17 | |
| Overall Study | COMPLETED | Fentanyl (Low Dose) | 16 | |
| Overall Study | COMPLETED | Fentanyl (Low Dose) + Dexmedetomidine | 15 | |
| Overall Study | NOT COMPLETED | Fentanyl (High Dose) | 0 | |
| Overall Study | NOT COMPLETED | Fentanyl (Low Dose) | 0 | |
| Overall Study | NOT COMPLETED | Fentanyl (Low Dose) + Dexmedetomidine | 3 |
Source ClinicalTrials.gov
Adverse events6
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 | Unblinded | Surgical and medical procedures | Fentanyl (High Dose) | 0 | 17 | 0 |
| other | Unblinded | Surgical and medical procedures | Fentanyl (Low Dose) | 0 | 16 | 0 |
| other | Unblinded | Surgical and medical procedures | Fentanyl (Low Dose) + Dexmedetomidine | 1 | 18 | 1 |
| serious | Morbidity | Surgical and medical procedures | Fentanyl (High Dose) | 0 | 17 | 0 |
| serious | Morbidity | Surgical and medical procedures | Fentanyl (Low Dose) | 0 | 16 | 0 |
| serious | Morbidity | Surgical and medical procedures | Fentanyl (Low Dose) + Dexmedetomidine | 2 | 18 | 2 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fentanyl (High Dose) | ||
| Total, all-cause mortality | Fentanyl (Low Dose) | ||
| Total, all-cause mortality | Fentanyl (Low Dose) + Dexmedetomidine | ||
| Total, other adverse events | Fentanyl (High Dose) | 0 | 17 |
| Total, other adverse events | Fentanyl (Low Dose) | 0 | 16 |
| Total, other adverse events | Fentanyl (Low Dose) + Dexmedetomidine | 1 | 18 |
| Total, serious adverse events | Fentanyl (High Dose) | 0 | 17 |
| Total, serious adverse events | Fentanyl (Low Dose) | 0 | 16 |
| Total, serious adverse events | Fentanyl (Low Dose) + Dexmedetomidine | 2 | 18 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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
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