SPECS: Safe Pediatric Euglycemia in Cardiac Surgery

Hyperglycemia Clinical Trial

— SPECS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443599
• Other study ID #: 512
• Secondary ID: 5R01HL088448-05
• Status: Completed
• Phase: N/A
• Start date: November 2006
• Est. completion date: January 2014

Study information

• Verified date: July 2022
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Children undergoing heart surgery are under significant bodily stress, which can lead to higher than normal or lower than normal blood glucose levels. A synthetic form of insulin, a naturally occurring hormone in the body, can be injected into people to normalize blood glucose levels. Insulin is most commonly used to treat people with diabetes, but it is also used in hospitals to control blood glucose levels in patients. Previous studies of adult intensive care unit (ICU) patients have shown that patients whose blood sugar levels are maintained at normal levels with the use of insulin contract fewer infections and are released more quickly from the ICU than patients who do not maintain normal blood glucose levels. This study will use a continuous blood glucose monitoring system to detect changes in blood glucose levels. Intravenous insulin infusions will be used to then safely maintain normal blood glucose levels. The purpose of this study is to determine if maintaining normal blood glucose levels during an ICU stay will help decrease the incidence of infections and improve surgical recovery in young children following heart surgery. This study will enroll children who are undergoing heart surgery that requires a cardiopulmonary bypass procedure. Participants will be randomly assigned to either a control group or the treatment group. All participants will receive usual care while in the ICU and will undergo continuous glucose monitoring. Participants in the treatment group will receive intravenous insulin infusions to keep their blood glucose within the normal range. While in the ICU, blood will be collected from all participants once a day for the first 3 days and then once a week to monitor glucose levels, hormone levels, and measurements of nutrition and immune function. On days 1 and 5 following surgery, participants who are on a ventilator will have their breath measured to monitor heart function and energy use. Thirty days and 1 year following surgery, study researchers will contact the participant's parent or doctor to collect information on health status and any new infections at the surgical site. Children who enroll in the study will be asked to participate in follow-up neurodevelopmental evaluations at 1 and 3 years of age to assess longer term cognitive effects of tight glycemic control in the ICU.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 989
• Est. completion date: January 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital
• Hyperglycemia

Intervention

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.

Locations

Country	Name	City	State
United States	C.S. Mott Children's Hospital	Ann Arbor	Michigan
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children's Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Agus MS, Javid PJ, Piper HG, Wypij D, Duggan CP, Ryan DP, Jaksic T. The effect of insulin infusion upon protein metabolism in neonates on extracorporeal life support. Ann Surg. 2006 Oct;244(4):536-44. — View Citation

Agus MS, Javid PJ, Ryan DP, Jaksic T. Intravenous insulin decreases protein breakdown in infants on extracorporeal membrane oxygenation. J Pediatr Surg. 2004 Jun;39(6):839-44; discussion 839-44. — View Citation

Agus MS, Steil GM, Wypij D, Costello JM, Laussen PC, Langer M, Alexander JL, Scoppettuolo LA, Pigula FA, Charpie JR, Ohye RG, Gaies MG; SPECS Study Investigators. Tight glycemic control versus standard care after pediatric cardiac surgery. N Engl J Med. 2 — View Citation

Gaies MG, Langer M, Alexander J, Steil GM, Ware J, Wypij D, Laussen PC, Newburger JW, Goldberg CS, Pigula FA, Shukla AC, Duggan CP, Agus MS; Safe Pediatric Euglycemia after Cardiac Surgery Study Group. Design and rationale of safe pediatric euglycemia after cardiac surgery: a randomized controlled trial of tight glycemic control after pediatric cardiac surgery. Pediatr Crit Care Med. 2013 Feb;14(2):148-56. doi: 10.1097/PCC.0b013e31825b549a. — View Citation

Javid PJ, Halwick DR, Betit P, Thompson JE, Long K, Zhang Y, Jaksic T, Agus MS. The first use of live continuous glucose monitoring in patients on extracorporeal life support. Diabetes Technol Ther. 2005 Jun;7(3):431-9. — View Citation

Piper HG, Alexander JL, Shukla A, Pigula F, Costello JM, Laussen PC, Jaksic T, Agus MS. Real-time continuous glucose monitoring in pediatric patients during and after cardiac surgery. Pediatrics. 2006 Sep;118(3):1176-84. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Nosocomial Infections in the Cardiac ICU	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.	Measured during participant's ICU stay, a median duration of 3 days.
Secondary	Cardiac Index (CI)	Cardiac index is a measure of cardiac function, relating the cardiac output from the left ventricle in one minute to body surface area. It is calculated using the Fick principle, using oxygen consumption measured with a metabolic cart, hemoglobin levels, and the difference between arterial and superior vena cava oxygen saturation measured by co-oximetry.	Day 2 (day after cardiopulmonary bypass surgery).
Secondary	Duration of ICU Stay	Duration of ICU stay spans from post-operative cardiac ICU admission to cardiac ICU discharge.	The duration of cardiac ICU stay was evaluated from the date of postoperative cardiac ICU admission until the date of cardiac ICU discharge or date of death from any cause, whichever came first, assessed up to 30 days.
Secondary	Duration of Hospital Stay	Duration of hospital stay spans from post-operative cardiac ICU admission to hospital discharge.	The duration of hospital stay was evaluated from the day of postoperative cardiac ICU admission until the day of hospital discharge or day of death from any cause, whichever came first, assessed up to 30 days.
Secondary	Duration of Endotracheal Intubation	Duration of endotracheal intubation spans from endotracheal tube intubation/initiation of mechanical ventilation to endotracheal tube extubation.	The duration of endotracheal intubation (mechanical ventilation) was evaluated from the day of postoperative cardiac ICU admission until the day of extubation or day of death from any cause, whichever came first, assessed up to 30 days.
Secondary	Mortality at Hospital Discharge.	Mortality is assessed at hospital discharge and at 30 days.	Mortality at hospital discharge (In-hospital mortality) was evaluated on the day of hospital discharge or day of death from any cause, whichever came first (no upper limit).
Secondary	Mortality at 30 Days.	Mortality is assessed at hospital discharge and at 30 days. If the participant is discharged from the hospital prior to 30 days, status is determined by a follow-up phone call to the family.	Measured at 30 days.
Secondary	Cardiac Function	Cardiac function is assessed by duration of vasoactive support.	The duration of vasoactive support was evaluated from the day of postoperative cardiac ICU admission until the last day of vasoactive support or day of death from any cause, whichever came first, assessed up to 30 days.
Secondary	Immune Function	Immune function is assessed by C-reactive protein (CRP) on post-operative day 7.	Post-operative day 7.
Secondary	Endocrine Function	Endocrine function is assessed by total triiodothyronine (T3) on post-operative day 7.	Measured during participant's ICU stay on Day 7.
Secondary	Nutritional Status	Nutritional status assessed by percentage of total caloric intake as enteral nutrition during critical illness period.	The percentage of total caloric intake was evaluated from the day of postoperative cardiac ICU admission until the last day of the critical illness period, as defined by the presence of the arterial catheter, assessed up to 30 days.
Secondary	Neurodevelopmental Evaluation, Cognitive	Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.; Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154.; Higher values indicate better neurodevelopmental outcomes.; These three composite scores cannot be combined and are presented as separate scores in the literature.	Measured at one year of age.
Secondary	Neurodevelopmental Evaluation, Language	Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.; Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154.; Higher values indicate better neurodevelopmental outcomes.; These three composite scores cannot be combined and are presented as separate scores in the literature.	Measured at one year of age.
Secondary	Neurodevelopmental Evaluation, Motor	Neurodevelopmental follow-up includes in-person testing using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), measured at one year of age.; Bayley-III cognitive composite score ranges from 55-145, Bayley-III language composite score ranges from 47-153, and Bayley-III motor composite score ranges from 46-154.; Higher values indicate better neurodevelopmental outcomes.; These three composite scores cannot be combined and are presented as separate scores in the literature.	Measured at one year of age.