CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 989 enrolled
Drug / intervention
Insulin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00443599
NCT00443599N/ACompleted
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Maintaining Normal Blood Sugar Levels in Children Undergoing Heart Surgery to Reduce the Risk of Infections and Improve Recovery (The SPECS Study)

Boston Children's Hospital·interventional·Posted Mar 6, 2007·Updated Jul 25, 2022

In Brief

A clinical study evaluating Insulin and Usual Care for Heart Defects, Congenital and Hyperglycemia. Completed, enrolled 989 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Defects, Congenital, Hyperglycemia
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 6, 2007
Enrollment StartNov 1, 2006
Primary CompletionJun 1, 2012
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 19.3 years ago

Interventions

Insulindrug

Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.

Usual Careother

Participants receive standard Cardiac ICU care without tight blood glucose control.