N/A
N=989
SPECS: Safe Pediatric Euglycemia in Cardiac Surgery
Heart Defects, Congenital · Hyperglycemia
Bottom Line
View on ClinicalTrials.gov: NCT00443599 ↗Enrolled (actual)
989
Serious AEs
2.1%
Results posted
Mar 2014
Primary outcome: Primary: Incidence of Nosocomial Infections in the Cardiac ICU — 8.6; 9.9 infections / 1000 pt days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Insulin (Drug); Usual Care (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Nosocomial Infections in the Cardiac ICU |
8.6; 9.9 | — |
| SECONDARY Cardiac Index (CI) |
2.0; 1.8 | — |
| SECONDARY Duration of ICU Stay |
3; 3 | — |
| SECONDARY Duration of Hospital Stay |
8; 7 | — |
| SECONDARY Duration of Endotracheal Intubation |
3; 2 | — |
| SECONDARY Mortality at Hospital Discharge. |
11; 11 | — |
| SECONDARY Mortality at 30 Days. |
5; 6 | — |
| SECONDARY Cardiac Function |
2; 2 | — |
| SECONDARY Immune Function |
3.1; 4.3 | — |
| SECONDARY Endocrine Function |
84; 75 | — |
| SECONDARY Nutritional Status |
41; 38 | — |
| SECONDARY Neurodevelopmental Evaluation, Cognitive |
100.2; 100.8 | — |
| SECONDARY Neurodevelopmental Evaluation, Language |
94.7; 94.7 | — |
| SECONDARY Neurodevelopmental Evaluation, Motor |
87.2; 88.9 | — |
Summary
Critically ill children, including children undergoing heart surgery, commonly develop elevated blood glucose (also known as "blood sugar") levels during their illness, which can lead to poor health outcomes and an increased risk of death. This study will examine the effectiveness of maintaining normal blood glucose levels at decreasing infections and improving recovery in young children undergoing heart surgery.
Eligibility Criteria
Inclusion Criteria
- Undergoing heart surgery with cardiopulmonary bypass
- Recovering in the Cardiac ICU
Exclusion Criteria
- Enrolled in another interventional clinical trial with related study outcomes
Data sourced from ClinicalTrials.gov (NCT00443599). 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.