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SPECS: Safe Pediatric Euglycemia in Cardiac Surgery

NCT00443599 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 989

Last updated 2022-07-25

Study results available
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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.

Conditions

Interventions

DRUG

Insulin

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.

OTHER

Usual Care

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

Sponsors & Collaborators

Principal Investigators

  • Michael Agus, MD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2012-06-30
Completion
2014-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00443599 on ClinicalTrials.gov