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NCT00443599 · ClinicalTrials.gov registry record · NA
SPECS: Safe Pediatric Euglycemia in Cardiac Surgery
A NA study of Hyperglycemia and Heart Defects, Congenital, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 989
- Enrollment target
- 2
- Study locations
NCT00443599: Completed NA study of Hyperglycemia and Heart Defects, Congenital, sponsored by Boston Children's Hospital.
NCT00443599 is a NA study of Hyperglycemia and Heart Defects, Congenital that has completed, run by Boston Children's Hospital. The registered enrollment target is 989 participants, above the 853-participant average among 38 other Hyperglycemia trials with a reported enrollment target (16% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00443599, a NA study of Hyperglycemia and Heart Defects, Congenital, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 989 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Nosocomial infections that are attributable to the subject's stay in the Cardiac ICU, according to Center for Disease Control-defined criteria. These definitions are extensive and cannot be accurately condensed to fit within this space. Current CDC/NHSN criteria may be accessed through this URL: https://www.cdc.gov/nhsn/pdfs/pscmanual/17pscnosinfdef\_current.pdf.
Conditions Studied
Interventions
- OTHER Usual Care
- DRUG Insulin
Study Locations (2)
Massachusetts
- Children's Hospital Boston - Boston
Michigan
- C.S. Mott Children's Hospital - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 989 participants |
| Start Date | 2006-11 |
| Est. Completion | 2014-01 |
| Phase | NA |
What the finished NCT00443599 record still lists
NCT00443599 is an interventional study that assigns participants to a tested intervention. The registered 989 participants enrollment target is mid-sized for trials with a published cap, above the 853-participant average among 38 other Hyperglycemia trials with a reported enrollment target (16% higher).
The record links to 2 conditions, with Hyperglycemia appearing as the primary indexed condition, and to 2 interventions - of which Usual Care is the first listed.
NCT00443599 reports a single indexed study location in Massachusetts, Michigan.
Frequently Asked Questions
What is clinical trial NCT00443599 about?
NCT00443599 is a clinical study titled "SPECS: Safe Pediatric Euglycemia in Cardiac Surgery". 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 nor...
What is the current status of trial NCT00443599?
This trial is currently completed. It is a NA study. The enrollment target is 989 participants. The study started on 2006-11. Estimated completion is 2014-01.
What conditions does trial NCT00443599 study?
This clinical trial studies the following conditions: Hyperglycemia, Heart Defects, Congenital.
What interventions are being tested in trial NCT00443599?
The interventions under investigation include: Usual Care (OTHER), Insulin (DRUG).
Who is sponsoring clinical trial NCT00443599?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00443599 being conducted?
This trial has 2 study locations across Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00443599's enrollment target sits among peer trials
989 5th of 38 higher than 34 of 38 other Hyperglycemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hyperglycemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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