Phase 2
Completed N=51
Measures to Lower the Stress Response in Pediatric Cardiac Surgery
Tetralogy of Fallot (TOF) · Ventricular Septal Defects (VSD) · Atrioventricular Septal Defects (AVSD)
Source: ClinicalTrials.gov NCT00848393 ↗
Enrolled (actual)
51
Serious AEs
3.9%
Results posted
Jul 2018
Primary outcomePrimary: ACTH and Cytokine Levels — 116.9; 182.7; 135.3; 44.5 pg/mL
Summary
Cardiac surgery induces a measurable stress response in patients which leads to increased morbidity and mortality post-operatively. Through clinical observation, anesthesiologists have determined that varying the combinations of anesthesia drugs used during surgery and just after reduces the stress response, and by extension, morbidity and mortality. However, only a few studies have explored this phenomenon scientifically.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ACTH and Cytokine Levels |
116.9; 182.7; 135.3; 44.5; 86.2; 106.9 | — |
| PRIMARY Comparisons Between Groups for Narcotic and/or Dexmedetomidine Intervention Influence on Length of CTICU Stay. |
1; 1; 2 | — |
| PRIMARY Comparisons Between Groups for Narcotic and/or Dexmedetomidine Intervention Influence on Time on Ventilator. |
10.75; 3.79; 2.4 | — |
| PRIMARY Stanford-Binet Intelligence Scales |
92; 98; 89; 93; 91; 80 | — |
| PRIMARY Stress Hormone Levels |
13.32618; 19.34153; 19.45968; 16.2606; 17.08766; 12.74458 | — |
| SECONDARY Stanford-Binet Cognitive Ability |
106; 96; 82; 91; 97; 95 | — |
| SECONDARY ABAS-II |
96; 102; 100; 99; 106; 99 | — |
Eligibility Criteria
Inclusion Criteria
- Childrens with the diagnosis of tetralogy of fallot, ventricular septal defect and atrioventricular septal defect who are under one year of age.
Exclusion Criteria
- Patients who are having reoperation.
- Patients with comorbidities, such as heart failure.
- Patients receiving digoxin preoperatively.
Data sourced from ClinicalTrials.gov (NCT00848393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.